Trial Outcomes & Findings for To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure (NCT NCT01829347)

NCT ID: NCT01829347

Last Updated: 2019-02-19

Results Overview

The primary endpoint of the study was a comparison of overall survival (OS) between ELAD-treated and Control groups, with protocol VTI-210E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (11 July 2016).

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 18 participants
• Primary outcome timeframe: Up to at least Study Day 91, with protocol VTI-208E providing additional survival data at the time of database lock (11 July 2016), approximately 27 months
• Results posted on: 2019-02-19

Participant Flow

Participant milestones

Measure	ELAD (Plus Standard of Care) Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care treatment for a period of up to 10 days, followed by Standard of Care treatment through Study Day 91.	Standard of Care (Control) Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
VTI-210 STARTED	9	9
VTI-210 COMPLETED	3	6
VTI-210 NOT COMPLETED	6	3
VTI-210E STARTED	3	6
VTI-210E COMPLETED	0	0
VTI-210E NOT COMPLETED	3	6

Reasons for withdrawal

Measure	ELAD (Plus Standard of Care) Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care treatment for a period of up to 10 days, followed by Standard of Care treatment through Study Day 91.	Standard of Care (Control) Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
VTI-210 Death	5	3
VTI-210 Withdrawal by Subject	1	0
VTI-210E Death	2	1
VTI-210E Study terminated prematurely	1	5

Baseline Characteristics

To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure

Baseline characteristics by cohort

Measure	ELAD (Plus Standard of Care) n=9 Participants Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care treatment for a period of up to 10 days, followed by Standard of Care treatment through Study Day 91.	Standard of Care (Control) n=9 Participants Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	46.1 years STANDARD_DEVIATION 7.29 • n=5 Participants	50.0 years STANDARD_DEVIATION 9.79 • n=7 Participants	48.1 years STANDARD_DEVIATION 8.61 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United Kingdom	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Spain	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Baseline MELD Score	27.531 MELD Score STANDARD_DEVIATION 2.8870 • n=5 Participants	26.323 MELD Score STANDARD_DEVIATION 2.8524 • n=7 Participants	26.962 MELD Score STANDARD_DEVIATION 2.8484 • n=5 Participants

PRIMARY outcome

Timeframe: Up to at least Study Day 91, with protocol VTI-208E providing additional survival data at the time of database lock (11 July 2016), approximately 27 months

The primary endpoint of the study was a comparison of overall survival (OS) between ELAD-treated and Control groups, with protocol VTI-210E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (11 July 2016).

Outcome measures

Measure	ELAD (Plus Standard of Care) n=9 Participants Participants randomized to the ELAD group received ELAD treatment plus protocol-directed standard of care treatment for a period of up to 10 days followed by standard of care treatment through Study Day 91.	Standard of Care (Control) n=9 Participants Participants randomized to the Control group received protocol-directed standard of care treatment in accord with AASLD and EASL guidelines for up to 91 days.
Overall Survival	2 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to Study Day 91.

Assess the proportion of survivors at Study Day 91.

Outcome measures

Measure	ELAD (Plus Standard of Care) n=9 Participants Participants randomized to the ELAD group received ELAD treatment plus protocol-directed standard of care treatment for a period of up to 10 days followed by standard of care treatment through Study Day 91.	Standard of Care (Control) n=9 Participants Participants randomized to the Control group received protocol-directed standard of care treatment in accord with AASLD and EASL guidelines for up to 91 days.
Proportion of Survivors at Study Day 91.	5 Participants	6 Participants

Adverse Events

ELAD (Plus Standard of Care)

Serious events: 6 serious events

Other events: 9 other events

Deaths: 7 deaths

Standard of Care (Control)

Serious events: 5 serious events

Other events: 9 other events

Deaths: 4 deaths

Serious adverse events

Measure	ELAD (Plus Standard of Care) n=9 participants at risk Participants randomized to the ELAD group received ELAD treatment plus protocol-directed standard of care treatment for a period of up to 10 days followed by standard of care treatment through Study Day 91.	Standard of Care (Control) n=9 participants at risk Participants randomized to the Control group received protocol-directed standard of care treatment in accord with AASLD and EASL guidelines for up to 91 days.
Cardiac disorders Cardiac arrest	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Ascites	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Gastrointestinal haemorrhage	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Melaena	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Hepatobiliary disorders Alcoholic liver disease	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Hepatobiliary disorders Hepatitis alcoholic	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Infections and infestations Peritonitis bacterial	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Infections and infestations Sepsis	11.1% 1/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Infections and infestations Septic shock	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Metabolism and nutrition disorders Fluid retention	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Metabolism and nutrition disorders Hyponatraemia	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Nervous system disorders Hepatic encephalopathy	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Renal and urinary disorders Acute kidney injury	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Respiratory failure	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Vascular disorders Haematoma	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.

Other adverse events

Measure	ELAD (Plus Standard of Care) n=9 participants at risk Participants randomized to the ELAD group received ELAD treatment plus protocol-directed standard of care treatment for a period of up to 10 days followed by standard of care treatment through Study Day 91.	Standard of Care (Control) n=9 participants at risk Participants randomized to the Control group received protocol-directed standard of care treatment in accord with AASLD and EASL guidelines for up to 91 days.
Blood and lymphatic system disorders Anaemia	77.8% 7/9 • Number of events 7 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Blood and lymphatic system disorders Coagulopathy	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Blood and lymphatic system disorders Haemolysis	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Blood and lymphatic system disorders Splenomegaly	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Blood and lymphatic system disorders Thrombocytopenia	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Cardiac disorders Cardiomegaly	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Ear and labyrinth disorders Middle ear effusion	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Endocrine disorders Hypothyroidism	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Abdominal distension	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Abdominal pain	33.3% 3/9 • Number of events 3 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Abdominal tenderness	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Ascites	33.3% 3/9 • Number of events 4 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	44.4% 4/9 • Number of events 4 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Colonic pseudo-obstruction	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Constipation	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Diarrhoea	22.2% 2/9 • Number of events 3 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Duodenal ulcer	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Gastrointestinal angiodysplasia	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Gastrooesophageal reflux disease	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Haemorrhoidal haemorrhage	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Nausea	22.2% 2/9 • Number of events 3 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Rectal haemorrhage	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Stomatitis	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Varices oesophageal	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Gastrointestinal disorders Vomiting	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
General disorders Asthenia	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
General disorders Catheter site haemorrhage	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
General disorders Device malfunction	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
General disorders Generalised oedema	33.3% 3/9 • Number of events 3 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
General disorders Medical device complication	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
General disorders Non-cardiac chest pain	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
General disorders Oedema	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
General disorders Oedema peripheral	33.3% 3/9 • Number of events 4 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	33.3% 3/9 • Number of events 3 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
General disorders Pain	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
General disorders Pyrexia	22.2% 2/9 • Number of events 6 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	22.2% 2/9 • Number of events 3 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
General disorders Xerosis	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Infections and infestations Bacteraemia	33.3% 3/9 • Number of events 7 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	22.2% 2/9 • Number of events 4 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Infections and infestations Cellulitis	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Infections and infestations Gingival abscess	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Infections and infestations Oesophageal candidiasis	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Infections and infestations Pneumonia	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Infections and infestations Sepsis	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Infections and infestations Septic shock	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Infections and infestations Urinary tract infection	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Infections and infestations Urinary tract infection fungal	11.1% 1/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Infections and infestations Vulval cellulitis	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Injury, poisoning and procedural complications Perineal injury	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Injury, poisoning and procedural complications Periorbital haematoma	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Metabolism and nutrition disorders Fluid overall	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Metabolism and nutrition disorders Hyperammonaemia	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Metabolism and nutrition disorders Hyperglycaemia	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Metabolism and nutrition disorders Hypocalcaemia	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Metabolism and nutrition disorders Hypokalaemia	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Metabolism and nutrition disorders Hypomagnesaemia	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Metabolism and nutrition disorders Hypophosphataemia	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Metabolism and nutrition disorders Lactic acidosis	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Metabolism and nutrition disorders Metabolic acidosis	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Musculoskeletal and connective tissue disorders Critical illness myopathy	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Nervous system disorders Asterixis	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Nervous system disorders Headache	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Nervous system disorders Hepatic encephalopathy	33.3% 3/9 • Number of events 4 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Nervous system disorders Irregular sleep phase	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Nervous system disorders Stupor	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Nervous system disorders Tremor	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Psychiatric disorders Depression	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Psychiatric disorders Flat affect	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Psychiatric disorders Insomnia	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Renal and urinary disorders Acute kidney injury	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Renal and urinary disorders Renal failure	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Renal and urinary disorders Renal impairment	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Reproductive system and breast disorders Hydrocele	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Reproductive system and breast disorders Scrotal oedema	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Atelectasis	22.2% 2/9 • Number of events 3 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Bronchospasm	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 3/9 • Number of events 4 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Epistaxis	22.2% 2/9 • Number of events 3 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Haemoptysis	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Hiccups	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Respiratory failure	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Tachypnoea	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Respiratory, thoracic and mediastinal disorders Wheezing	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Skin and subcutaneous tissue disorders Blister	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Skin and subcutaneous tissue disorders Contusion	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Skin and subcutaneous tissue disorders Decubitus ulcer	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Skin and subcutaneous tissue disorders Ecchymosis	22.2% 2/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Skin and subcutaneous tissue disorders Excoriation	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Skin and subcutaneous tissue disorders Hyperhidrosis	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • Number of events 2 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Skin and subcutaneous tissue disorders Pruritus generalised	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Skin and subcutaneous tissue disorders Rash	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Skin and subcutaneous tissue disorders Skin plaque	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Vascular disorders Hypotension	66.7% 6/9 • Number of events 7 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.
Vascular disorders Peripheral venous disease	0.00% 0/9 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.	11.1% 1/9 • Number of events 1 • Randomization through Study Day 91. Additional relevant information: It should be noted that the outcome of the serious adverse events is recorded as the subject status at Study Day 91. Note, one serious adverse event (melaena) was ongoing at Study Day 91, and ultimately resulted in death of the subject at Study Day 91, at which time the subject had entered VTI-210E.

Additional Information

Robert Ashley

Vital Therapies, Inc.

Phone: 858-673-6840

Email: rashley@vitaltherapies.com

Results disclosure agreements

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