Effects of Long-Term Administration of Human Albumin in P... | NCT03451292

ID	Type	Description	Link
2016-001789-28	EudraCT Number

Name	Class
Instituto Grifols, S.A.	INDUSTRY

Label	Type	Description	Intervention Names
SMT + Albutein 20%	Experimental	Participants received Albutein 20%, at a dose of 1.5 grams/kilograms (g/kg), based on their body weight (maximum 100 grams per participant), as an intravenous (IV) infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with standard medical treatment (SMT) administered as per institution standards for the management of decompensated cirrhosis up to 12 months.	Drug: Albutein 20% Other: SMT
SMT	Active Comparator	Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.	Other: SMT

Name	Type	Description	Arm Group Labels	Other Names
Albutein 20%	Drug	Injectable solution	SMT + Albutein 20%
SMT

Measure	Description	Time Frame
Time to Liver Transplantation or Death Through 1 Year After Randomization: Percentage of Participants With an Event	Time to one-year transplant-free survival was calculated as earlier of [(date of liver transplantation or date of death) - randomization date + 1] for participants who died or had liver transplant within the analysis period of 361 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 361, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as [(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)].	Up to Day 361

Measure	Description	Time Frame
Time to Liver Transplantation or Death Through 3 Months After Randomization: Percentage of Participants With an Event	Time to 3-months transplant-free survival was calculated as earlier of [(date of liver transplantation or date of death) - randomization date + 1] for participants who died or had liver transplant within the analysis period of 91 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 91, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as [(participants with an event up to the analysis cut-off Day 91) / (number of participants in the ITT group)].

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female participants ≥18 years of age.
Participants with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
Participants who have been hospitalized for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without ACLF at admission or during hospitalization but without ACLF at Screening.
In participants with cirrhosis due to hepatitis B virus, decompensation must occur in the setting of continuous (no less than 3 months) appropriate antiviral therapy.
In participants with cirrhosis due to hepatitis C virus, only decompensated participants who will not receive antiviral therapy during the study period will be included (Participants receiving antiviral therapy within 14 days prior to enrollment cannot be included in the study).
In participants with cirrhosis due to autoimmune hepatitis, decompensation must occur in the setting of continuous immunosuppressive therapy.
Participants must be willing and able to provide written informed consent or have an authorized representative able to provide written informed consent on behalf of the participant in accordance with local law and institutional policy.
Chronic liver failure-consortium acute decompensation (CLIF-C AD) score > 50 points at screening.

Exclusion Criteria:

Participants with ACLF at Screening
Participants with type 1 hepatorenal syndrome (HRS) currently on treatment with vasoconstrictors or hemodialysis.
Participants with transjugular intrahepatic portosystemic shunt (TIPS) or other surgical porto-caval shunts.
Participants with refractory ascites as defined by the International Club of Ascites (ICA) criteria without any other event of acute decompensation.
Participants receiving dual anti-platelet therapy or anti-coagulant therapy (exception: deep vein thrombosis (DVT) prophylaxis).
Participants with ongoing endoscopic eradication of esophageal varices with ≤ 2 endoscopic sessions completed before screening.
Participants with evidence of current locally advanced or metastatic malignancy.
Participants with acute or chronic heart failure (New York Heart Association [NYHA]).
Participants with severe (grade III or IV) pulmonary disease (Global Obstructive Lung Disease [GOLD]).
Participants with nephropathy with renal failure with serum creatinine >2 milligrams/deciliters (mg/dL) or systemic hypertension.
Participants with severe psychiatric disorders.
Participants with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection.
Females who are pregnant, breastfeeding, or if of childbearing potential, unwilling to practice effective methods of contraception
Participants with previous liver transplantation.
Participants with known or suspected hypersensitivity to albumin.
Participants participating in another clinical study within 3 months prior to screening.
Participants with active drug addiction (exceptions: active alcoholism or marijuana).
In the opinion of the investigator, the participants may have compliance problems with the protocol and the procedures of the protocol.
Participants with ongoing or recent variceal bleeding (participants can be included 2 weeks after hemorrhagic episode).
Participants with septic shock at screening.
Participants with ongoing spontaneous bacterial peritonitis (SBP) infection (participants can be included upon resolution).
Participants with current infection of coronavirus disease of 2019 (COVID19), those who are less than 14 days post recovery, or those who have clinical signs and symptoms consistent with COVID19 infection.

Facility	Status	City	State	ZIP	Country	Contacts
Southern California Research Center		Coronado	California	92118	United States
University of Miami Hospital

PubMed Identifier	Type	Citation	Retractions
30905652	Derived	Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.

ID	Title	Description
FG000	SMT + Albutein 20%	Participants received Albutein 20%, at a dose of 1.5 grams/kilograms (g/kg), based on their body weight (maximum 100 grams per participant), as an intravenous (IV) infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 24, 2020	May 21, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Liver Transplantation or Death Through 1 Year After Randomization: Percentage of Participants With an Event

Time to one-year transplant-free survival was calculated as earlier of [(date of liver transplantation or date of death) - randomization date + 1] for participants who died or had liver transplant within the analysis period of 361 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 361, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as [(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)].

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Up to Day 361

ID	Title	Description
OG000	SMT + Albutein 20%	Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.
OG001	SMT Alone	Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.

Units	Counts
Participants	OG000203 OG001207

Title

Denominators

Categories

Title	Measurements
	OG00033.5 OG00138.6

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Stratification factors included were the region (Europe or North America) and history of hospitalization for acute decompensation of liver cirrhosis (yes or no).	Cox Proportional- Hazards (PH) model		0.17		Hazard Ratio (HR)	0.80			2-Sided	95	0.58	1.10					Superiority

Secondary

Time to Liver Transplantation or Death Through 3 Months After Randomization: Percentage of Participants With an Event

Time to 3-months transplant-free survival was calculated as earlier of [(date of liver transplantation or date of death) - randomization date + 1] for participants who died or had liver transplant within the analysis period of 91 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 91, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as [(participants with an event up to the analysis cut-off Day 91) / (number of participants in the ITT group)].

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Up to Day 91

ID	Title	Description
OG000	SMT + Albutein 20%	Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.
OG001	SMT Alone

Secondary

Time to Liver Transplantation or Death Through 6 Months After Randomization: Percentage of Participants With an Event

Time to 6-months transplant-free survival was calculated as earlier of [(date of liver transplantation or date of death) - randomization date + 1] for participants who died or had liver transplant within the analysis period of 181 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 181, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as [(participants with an event up to the analysis cut-off Day 181) / (number of participants in the ITT group)].

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Up to Day 181

ID	Title	Description
OG000	SMT + Albutein 20%	Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.
OG001	SMT Alone

Secondary

Time to Death Through 3 Months After Randomization: Percentage of Participants With an Event

Time to 3-months survival was calculated as the earlier of [(date of death) - randomization date + 1] for those participants who died within the analysis period of 91 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 91 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as [(participants with an event up to the analysis cut-off Day 91) / (number of participants in the ITT group)].

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Up to Day 91

ID	Title	Description
OG000	SMT + Albutein 20%	Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.
OG001	SMT Alone

Secondary

Time to Death Through 6 Months After Randomization: Percentage of Participants With an Event

Time to 6-months survival was calculated as the earlier of [(date of death) - randomization date + 1] for those participants who died within the analysis period of 181 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 181 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as [(participants with an event up to the analysis cut-off Day 181) / (number of participants in the ITT group)].

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Up to Day 181

ID	Title	Description
OG000	SMT + Albutein 20%	Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.
OG001	SMT Alone

Secondary

Time to Death Through 1 Year After Randomization: Percentage of Participants With an Event

Time to 1 year survival was calculated as the earlier of [(date of death) - randomization date + 1] for those participants who died within the analysis period of 361 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 361 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as [(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)].

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Up to Day 361

ID	Title	Description
OG000	SMT + Albutein 20%	Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.
OG001	SMT Alone

Secondary

Total Number of Paracenteses Through 1 Year After Randomization

Paracenteses is a medical procedure used to remove excess fluid from the abdominal cavity. For each participant, the total number of reported paracenteses on treatment was calculated. Number of paracenteses per participant while on treatment was reported.

ITT population included all participants who were randomized.

Posted

Mean

Standard Deviation

paracenteses per participant

Up to Day 361

ID	Title	Description
OG000	SMT + Albutein 20%	Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.
OG001	SMT Alone	Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.

Units	Counts
Participants

Secondary

Number of Participants With Refractory Ascites According to the International Club of Ascites (ICA) Through 1 Year After Randomization

Refractory Ascites was defined as ascites that cannot be mobilized, or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic, or the development of diuretic-induced complications that preclude the use of an effective diuretic dosage treatment. Incidence of refractory ascites occurring on treatment was defined as any incidence that occurred with a start date/time on or after the participants date/time of randomization (for SMT Alone group) or commencement of Albutein (SMT+ Albutein 20% group) treatment.

ITT population included all participants who were randomized. Overall number of participants analyzed included participants with at least one refractory ascites assessment.

Posted

Count of Participants

Participants

Up to Day 361

ID	Title	Description
OG000	SMT + Albutein 20%	Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.
OG001	SMT Alone	Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0018 affected207 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0017 affected207 at risk
Sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0015 affected207 at risk
COVID-19 Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0011 affected207 at risk
Septic Shock	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0014 affected207 at risk
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0011 affected207 at risk
Cellulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0011 affected207 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0011 affected207 at risk
Systemic Candida	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0011 affected207 at risk
Enterococcal Bacteraemia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Influenza	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Wound Infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Clostridium Difficile Infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0013 affected207 at risk
Acute Endocarditis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Enterococcal Sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Erysipelas	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Escherichia Sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Gastroenteritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Peritonitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Pneumonia Aspiration	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Pneumonia Escherichia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Staphylococcal Bacteraemia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Staphylococcal Osteomyelitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Tuberculosis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Urinary Tract Infection Enterococcal	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Cardiac Failure	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0011 affected207 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0010 affected207 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0011 affected207 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0011 affected207 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Myocardial Injury	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Death	General disorders	MedDRA 27.0	Systematic Assessment	EG0005 affected203 at risk EG0014 affected207 at risk
Sudden death	General disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0011 affected207 at risk
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
General physical health deterioration	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Hernia	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Oedema peripheral	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0015 affected207 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0011 affected207 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0011 affected207 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0010 affected207 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00011 affected203 at risk EG0010 affected207 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0014 affected207 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0012 affected207 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Oesophagitis haemorrhagic	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Umbilical hernia, obstructive	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0010 affected207 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0010 affected207 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0010 affected207 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Strangulated incisional hernia	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Bone fissure	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Epilepsy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0013 affected207 at risk
Seizure	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0011 affected207 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0011 affected207 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0010 affected207 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0011 affected207 at risk
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Haematoma	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected203 at risk EG0011 affected207 at risk
Hypotension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Shock	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0013 affected207 at risk
Renal failure	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0012 affected207 at risk
Delirium tremens	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Device dislocation	Product Issues	MedDRA 27.0	Systematic Assessment	EG0001 affected203 at risk EG0010 affected207 at risk
Device breakage	Product Issues	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk
Gram stain positive	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected203 at risk EG0011 affected207 at risk

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	SMT + Albutein 20%	Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.
BG001	SMT Alone	Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SMT + Albutein 20%	Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.	53	203	52	203	51	203
EG001	SMT Alone	Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.	67	207	70	207	47	207

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00011 affected203 at risk EG0018 affected207 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0007 affected203 at risk EG00111 affected207 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG00014 affected203 at risk EG00117 affected207 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00013 affected203 at risk EG00115 affected207 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG00012 affected203 at risk EG0012 affected207 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00011 affected203 at risk EG0018 affected207 at risk