Trial Outcomes & Findings for Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites (NCT NCT03451292)
NCT ID: NCT03451292
Last Updated: 2025-06-06
Results Overview
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 \[(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)\].
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
410 participants
Primary outcome timeframe
Up to Day 361
Results posted on
2025-06-06
Participant Flow
A total of 410 participants took part in the study at 40 investigative sites across 14 countries in Europe and the United States from 24 July 2018 to 21 May 2024.
476 participants with decompensated cirrhosis and ascites were screened of which 410 participants were randomized in a 1:1 ratio to receive either the Standard Medical Treatment (SMT) + Albutein 20% or the SMT alone.
Participant milestones
| Measure |
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.
|
SMT Alone
Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
207
|
|
Overall Study
COMPLETED
|
110
|
105
|
|
Overall Study
NOT COMPLETED
|
93
|
102
|
Reasons for withdrawal
| Measure |
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.
|
SMT Alone
Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
|
|---|---|---|
|
Overall Study
Death
|
44
|
59
|
|
Overall Study
Withdrawal by Subject
|
18
|
13
|
|
Overall Study
Transplantation
|
18
|
12
|
|
Overall Study
Lost to Follow-up
|
4
|
12
|
|
Overall Study
Physician Decision
|
4
|
3
|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Non-compliance with Study Drug
|
2
|
0
|
Baseline Characteristics
Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites
Baseline characteristics by cohort
| Measure |
SMT + Albutein 20%
n=203 Participants
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.
|
SMT Alone
n=207 Participants
Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
|
Total
n=410 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 10.03 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 10.30 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 10.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
185 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
375 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
197 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
396 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 361Population: ITT population included all participants who were randomized.
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 \[(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)\].
Outcome measures
| Measure |
SMT + Albutein 20%
n=203 Participants
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.
|
SMT Alone
n=207 Participants
Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
|
|---|---|---|
|
Time to Liver Transplantation or Death Through 1 Year After Randomization: Percentage of Participants With an Event
|
33.5 percentage of participants
|
38.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 91Population: ITT population included all participants who were randomized.
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 \[(participants with an event up to the analysis cut-off Day 91) / (number of participants in the ITT group)\].
Outcome measures
| Measure |
SMT + Albutein 20%
n=203 Participants
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.
|
SMT Alone
n=207 Participants
Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
|
|---|---|---|
|
Time to Liver Transplantation or Death Through 3 Months After Randomization: Percentage of Participants With an Event
|
10.8 percentage of participants
|
17.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 181Population: ITT population included all participants who were randomized.
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 \[(participants with an event up to the analysis cut-off Day 181) / (number of participants in the ITT group)\].
Outcome measures
| Measure |
SMT + Albutein 20%
n=203 Participants
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.
|
SMT Alone
n=207 Participants
Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
|
|---|---|---|
|
Time to Liver Transplantation or Death Through 6 Months After Randomization: Percentage of Participants With an Event
|
22.7 percentage of participants
|
28.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 91Population: ITT population included all participants who were randomized.
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 \[(participants with an event up to the analysis cut-off Day 91) / (number of participants in the ITT group)\].
Outcome measures
| Measure |
SMT + Albutein 20%
n=203 Participants
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.
|
SMT Alone
n=207 Participants
Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
|
|---|---|---|
|
Time to Death Through 3 Months After Randomization: Percentage of Participants With an Event
|
9.4 percentage of participants
|
14.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 181Population: ITT population included all participants who were randomized.
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 \[(participants with an event up to the analysis cut-off Day 181) / (number of participants in the ITT group)\].
Outcome measures
| Measure |
SMT + Albutein 20%
n=203 Participants
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.
|
SMT Alone
n=207 Participants
Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
|
|---|---|---|
|
Time to Death Through 6 Months After Randomization: Percentage of Participants With an Event
|
16.7 percentage of participants
|
23.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 361Population: ITT population included all participants who were randomized.
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 \[(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)\].
Outcome measures
| Measure |
SMT + Albutein 20%
n=203 Participants
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.
|
SMT Alone
n=207 Participants
Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
|
|---|---|---|
|
Time to Death Through 1 Year After Randomization: Percentage of Participants With an Event
|
26.1 percentage of participants
|
31.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 361Population: ITT population included all participants who were randomized.
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.
Outcome measures
| Measure |
SMT + Albutein 20%
n=203 Participants
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.
|
SMT Alone
n=207 Participants
Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
|
|---|---|---|
|
Total Number of Paracenteses Through 1 Year After Randomization
|
1.3 paracenteses per participant
Standard Deviation 3.58
|
2.3 paracenteses per participant
Standard Deviation 5.07
|
SECONDARY outcome
Timeframe: Up to Day 361Population: ITT population included all participants who were randomized. Overall number of participants analyzed included participants with at least one refractory ascites assessment.
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.
Outcome measures
| Measure |
SMT + Albutein 20%
n=195 Participants
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.
|
SMT Alone
n=203 Participants
Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
|
|---|---|---|
|
Number of Participants With Refractory Ascites According to the International Club of Ascites (ICA) Through 1 Year After Randomization
|
33 Participants
|
46 Participants
|
Adverse Events
SMT + Albutein 20%
Serious events: 52 serious events
Other events: 51 other events
Deaths: 53 deaths
SMT Alone
Serious events: 70 serious events
Other events: 47 other events
Deaths: 67 deaths
Serious adverse events
| Measure |
SMT + Albutein 20%
n=203 participants at risk
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.
|
SMT Alone
n=207 participants at risk
Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
3.9%
8/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Urinary Tract Infection
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
3.4%
7/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Sepsis
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
2.4%
5/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
COVID-19 Pneumonia
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Septic Shock
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
1.9%
4/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
COVID-19
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Cellulitis
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Systemic Candida
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Enterococcal Bacteraemia
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Influenza
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Wound Infection
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
1.4%
3/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Acute Endocarditis
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Enterococcal Sepsis
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Pneumonia Aspiration
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Pneumonia Escherichia
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Staphylococcal Osteomyelitis
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Urinary Tract Infection Enterococcal
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Cardiac disorders
Cardiac Failure
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Cardiac disorders
Cardiac Arrest
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Cardiac disorders
Cardiomyopathy
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Cardiac disorders
Myocardial Injury
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
General disorders
Death
|
2.5%
5/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
1.9%
4/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
General disorders
Sudden death
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
General disorders
Pyrexia
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
General disorders
General physical health deterioration
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
General disorders
Hernia
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
General disorders
Oedema peripheral
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
2.4%
5/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Haematemesis
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Constipation
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
5.4%
11/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
1.9%
4/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.97%
2/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Injury, poisoning and procedural complications
Fall
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Injury, poisoning and procedural complications
Strangulated incisional hernia
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Nervous system disorders
Epilepsy
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
1.4%
3/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Nervous system disorders
Seizure
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Vascular disorders
Haematoma
|
0.99%
2/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Vascular disorders
Hypotension
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Vascular disorders
Shock
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Hepatobiliary disorders
Cholangitis
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
1.4%
3/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.97%
2/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Psychiatric disorders
Delirium tremens
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Product Issues
Device dislocation
|
0.49%
1/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.00%
0/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Product Issues
Device breakage
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Investigations
Gram stain positive
|
0.00%
0/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.48%
1/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
Other adverse events
| Measure |
SMT + Albutein 20%
n=203 participants at risk
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.
|
SMT Alone
n=207 participants at risk
Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.4%
11/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
3.9%
8/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.4%
7/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
5.3%
11/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.9%
14/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
8.2%
17/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Infections and infestations
Urinary tract infection
|
6.4%
13/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
7.2%
15/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
12/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
0.97%
2/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
11/203 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
3.9%
8/207 • Up to 12 months
The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site may publish results from the Study, after providing Sponsor 30 days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsors' request, Site will remove any Confidential Information (other than Study results), and Site will upon Sponsors' request, delay publication or presentation for a period of up to 120 days to allow Sponsor to protect its interests in any Sponsor Inventions.
- Publication restrictions are in place
Restriction type: OTHER