Trial Outcomes & Findings for Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids (NCT NCT00149890)
NCT ID: NCT00149890
Last Updated: 2011-09-22
Results Overview
Graft loss is defined as being listed for a re-transplantation. The analysis was based on the locally performed biopsy assessments. Generally, patients not experiencing a relevant event (i.e., acute rejection, graft loss or death) were censored with the last visit date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
77 participants
Primary outcome timeframe
3 months after treatment
Results posted on
2011-09-22
Participant Flow
Participant milestones
| Measure |
With Intraoperative Steroids
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
|
Without Intraoperative Steroids
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
38
|
|
Overall Study
COMPLETED
|
26
|
20
|
|
Overall Study
NOT COMPLETED
|
13
|
18
|
Reasons for withdrawal
| Measure |
With Intraoperative Steroids
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
|
Without Intraoperative Steroids
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
8
|
|
Overall Study
Lack of Efficacy
|
8
|
9
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Graft Loss
|
2
|
1
|
Baseline Characteristics
Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
Baseline characteristics by cohort
| Measure |
With Intraoperative Steroids
n=39 Participants
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
|
Without Intraoperative Steroids
n=38 Participants
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
3.08 years
STANDARD_DEVIATION 4.09 • n=39 Participants
|
3.71 years
STANDARD_DEVIATION 5.36 • n=41 Participants
|
3.39 years
STANDARD_DEVIATION 4.74 • n=35 Participants
|
|
Age, Customized
<2 years
|
21 participants
n=39 Participants
|
24 participants
n=41 Participants
|
45 participants
n=35 Participants
|
|
Age, Customized
from 2 to 16 years
|
18 participants
n=39 Participants
|
14 participants
n=41 Participants
|
32 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
37 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 3 months after treatmentPopulation: safety/Intent to Treat (ITT) population
Graft loss is defined as being listed for a re-transplantation. The analysis was based on the locally performed biopsy assessments. Generally, patients not experiencing a relevant event (i.e., acute rejection, graft loss or death) were censored with the last visit date.
Outcome measures
| Measure |
With Intraoperative Steroids
n=39 Participants
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
|
Without Intraoperative Steroids
n=38 Participants
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
|
|---|---|---|
|
Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation
Stratum age < 2 years (N=21, 24)
|
8 Participants
|
15 Participants
|
|
Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation
Stratum age 2-16 years (N=18, 14)
|
14 Participants
|
11 Participants
|
|
Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation
Total (N= 39, 38)
|
22 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: safety/Intent to Treat (ITT) population
At biopsy of transplanted tissue sample, acute rejection has an onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever, and hypertension.
Outcome measures
| Measure |
With Intraoperative Steroids
n=39 Participants
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
|
Without Intraoperative Steroids
n=38 Participants
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
|
|---|---|---|
|
Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months
|
20 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 3 and 6 monthsPopulation: safety/Intent to Treat (ITT) population
To evaluate the efficacy of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the incidence of steroid resistant rejection episodes within three and six months.
Outcome measures
| Measure |
With Intraoperative Steroids
n=39 Participants
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
|
Without Intraoperative Steroids
n=38 Participants
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
|
|---|---|---|
|
Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months
Within 3 months post treatment
|
2 Participants
|
2 Participants
|
|
Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months
Within 6 months post treatment
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 months and 6 monthsPopulation: safety/Intent to Treat (ITT) population
Graft loss is defined as being listed for a re-transplantation.
Outcome measures
| Measure |
With Intraoperative Steroids
n=39 Participants
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
|
Without Intraoperative Steroids
n=38 Participants
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
|
|---|---|---|
|
Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation
Death within 3 months post treatment
|
0.0 Percentage of participants
|
2.6 Percentage of participants
|
|
Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation
Death within 6 months post treatment
|
0.0 Percentage of participants
|
2.6 Percentage of participants
|
|
Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation
Graft Loss within 3 months post treatment
|
5.1 Percentage of participants
|
2.6 Percentage of participants
|
|
Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation
Graft Loss within 6 months post treatment
|
5.1 Percentage of participants
|
5.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Safety Population
To evaluate the safety of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the episodes of bacterial, viral and fungal infections during six months.
Outcome measures
| Measure |
With Intraoperative Steroids
n=39 Participants
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
|
Without Intraoperative Steroids
n=38 Participants
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
|
|---|---|---|
|
Number of Participants With Bacterial, Viral and Fungal Infections During Six Months
Fungal
|
16 Participants
|
16 Participants
|
|
Number of Participants With Bacterial, Viral and Fungal Infections During Six Months
Viral
|
15 Participants
|
14 Participants
|
|
Number of Participants With Bacterial, Viral and Fungal Infections During Six Months
Bacterial
|
10 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: safety/Intent to Treat (ITT) population
Biopsied Tissue shows rejection at onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever and hypertension .
Outcome measures
| Measure |
With Intraoperative Steroids
n=39 Participants
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
|
Without Intraoperative Steroids
n=38 Participants
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
|
|---|---|---|
|
Time of Onset of a First Biopsy Proven Acute Rejection
|
1.93 Months
Interval 0.89 to
Upper bound of the Confidence Interval was not attained
|
0.75 Months
Interval 0.49 to 1.31
|
SECONDARY outcome
Timeframe: 3 and 6 monthsPopulation: Intention to treat population
To evaluate the proportion of patients with treatment failure treated with a therapy consisting of intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids within three and six months.
Outcome measures
| Measure |
With Intraoperative Steroids
n=39 Participants
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
|
Without Intraoperative Steroids
n=38 Participants
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
|
|---|---|---|
|
Percentage of Participants With Treatment Failure Within Three and Six Months
3 month: Age < 2 years (N= 21, 24)
|
0.00 Percentage of participants
Interval 0.0 to 16.11
|
4.17 Percentage of participants
Interval 0.11 to 21.12
|
|
Percentage of Participants With Treatment Failure Within Three and Six Months
3 month: Age 2-16 years (N= 18, 14)
|
11.11 Percentage of participants
Interval 1.38 to 34.71
|
7.14 Percentage of participants
Interval 0.18 to 33.87
|
|
Percentage of Participants With Treatment Failure Within Three and Six Months
3 Month: Total
|
5.13 Percentage of participants
Interval 0.63 to 17.32
|
5.26 Percentage of participants
Interval 0.64 to 17.75
|
|
Percentage of Participants With Treatment Failure Within Three and Six Months
6 month: Age < 2 years (N= 21, 24)
|
0.00 Percentage of participants
Interval 0.0 to 16.11
|
4.17 Percentage of participants
Interval 0.11 to 21.12
|
|
Percentage of Participants With Treatment Failure Within Three and Six Months
6 month: Age 2-16 years (N= 18, 14)
|
11.11 Percentage of participants
Interval 1.38 to 34.71
|
7.14 Percentage of participants
Interval 0.18 to 33.87
|
|
Percentage of Participants With Treatment Failure Within Three and Six Months
6 Month: Total
|
5.13 Percentage of participants
Interval 0.63 to 17.32
|
5.26 Percentage of participants
Interval 0.64 to 17.75
|
Adverse Events
With Intraoperative Steroids
Serious events: 18 serious events
Other events: 39 other events
Deaths: 0 deaths
Without Intraoperative Steroids
Serious events: 23 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
With Intraoperative Steroids
n=39 participants at risk
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
|
Without Intraoperative Steroids
n=38 participants at risk
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.6%
1/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Cardiac disorders
Cardiac arrest
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Congenital, familial and genetic disorders
Hydrocele
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Gastrointestinal disorders
Coeliac disease
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Gastrointestinal disorders
Ileal fistula
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Gastrointestinal disorders
Peritonitis
|
5.1%
2/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Gastrointestinal disorders
Small intestinal perforation
|
5.1%
2/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
General disorders
Device occlusion
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
General disorders
Disease progression
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
General disorders
Obstruction
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
General disorders
Pain
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
General disorders
Pyrexia
|
5.1%
2/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Hepatobiliary disorders
Cholangitis
|
5.1%
2/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Hepatobiliary disorders
Cholestasis
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Hepatobiliary disorders
Haemobilia
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Hepatobiliary disorders
Hepatic artery thrombosis
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Hepatobiliary disorders
Hepatic necrosis
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Hepatobiliary disorders
Hepatic vein thrombosis
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Hepatobiliary disorders
Portal vein stenosis
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Infections and infestations
Cytomegalovirus infection
|
12.8%
5/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Infections and infestations
Epstein-barr viraemia
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Infections and infestations
Gastroenteritis
|
5.1%
2/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Infections and infestations
Gastroenteritis astroviral
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Injury, poisoning and procedural complications
Biliary anastomosis complication
|
2.6%
1/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Injury, poisoning and procedural complications
Complications of transplanted liver
|
7.7%
3/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Injury, poisoning and procedural complications
Hepatic haematoma
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Injury, poisoning and procedural complications
Hepatic rupture
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/39 • 6 months
|
13.2%
5/38 • 6 months
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Investigations
Epstein-barr virus antibody positive
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Investigations
Hepatic enzyme increased
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Investigations
Immunosuppressant drug level decreased
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Investigations
Transaminases increased
|
5.1%
2/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.6%
1/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.6%
1/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytosis haematophagic
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Renal and urinary disorders
Renal impairment
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchomalacia
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic rupture
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hepatopulmonary syndrome
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Vascular disorders
Inferior vena caval occlusion
|
0.00%
0/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Vascular disorders
Intra-abdominal haematoma
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Vascular disorders
Intra-abdominal haemorrhage
|
2.6%
1/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Vascular disorders
Reperfusion injury
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
Other adverse events
| Measure |
With Intraoperative Steroids
n=39 participants at risk
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
|
Without Intraoperative Steroids
n=38 participants at risk
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
43.6%
17/39 • 6 months
|
44.7%
17/38 • 6 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
5.1%
2/39 • 6 months
|
15.8%
6/38 • 6 months
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
7.7%
3/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.1%
2/39 • 6 months
|
15.8%
6/38 • 6 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.6%
1/39 • 6 months
|
10.5%
4/38 • 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.6%
10/39 • 6 months
|
28.9%
11/38 • 6 months
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
2.6%
1/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Cardiac disorders
Bradycardia
|
2.6%
1/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Cardiac disorders
Tachycardia
|
7.7%
3/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Endocrine disorders
Hyperparathyroidism
|
5.1%
2/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Endocrine disorders
Hypothyroidism
|
7.7%
3/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
20.5%
8/39 • 6 months
|
36.8%
14/38 • 6 months
|
|
Gastrointestinal disorders
Ascites
|
30.8%
12/39 • 6 months
|
31.6%
12/38 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
38.5%
15/39 • 6 months
|
44.7%
17/38 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
6/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
51.3%
20/39 • 6 months
|
42.1%
16/38 • 6 months
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
15.4%
6/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Gastrointestinal disorders
Peritonitis
|
2.6%
1/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
25.6%
10/39 • 6 months
|
39.5%
15/38 • 6 months
|
|
General disorders
Drug withdrawal syndrome
|
17.9%
7/39 • 6 months
|
18.4%
7/38 • 6 months
|
|
General disorders
Obstruction
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
General disorders
Oedema
|
2.6%
1/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
General disorders
Pain
|
5.1%
2/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
General disorders
Pyrexia
|
48.7%
19/39 • 6 months
|
65.8%
25/38 • 6 months
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Hepatobiliary disorders
Bile duct necrosis
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Hepatobiliary disorders
Bile duct obstruction
|
5.1%
2/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Hepatobiliary disorders
Cholangitis
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Hepatobiliary disorders
Cholestasis
|
2.6%
1/39 • 6 months
|
18.4%
7/38 • 6 months
|
|
Hepatobiliary disorders
Hepatic ischaemia
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.1%
2/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Hepatobiliary disorders
Pneumobilia
|
7.7%
3/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Hepatobiliary disorders
Portal vein stenosis
|
2.6%
1/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Infections and infestations
Abdominal infection
|
5.1%
2/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Infections and infestations
Adenovirus infection
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Infections and infestations
Bacterial infection
|
2.6%
1/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Infections and infestations
Bronchitis
|
7.7%
3/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Infections and infestations
Candidiasis
|
17.9%
7/39 • 6 months
|
28.9%
11/38 • 6 months
|
|
Infections and infestations
Cytomegalovirus infection
|
15.4%
6/39 • 6 months
|
15.8%
6/38 • 6 months
|
|
Infections and infestations
Enterococcal infection
|
2.6%
1/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Infections and infestations
Epstein-barr virus infection
|
17.9%
7/39 • 6 months
|
23.7%
9/38 • 6 months
|
|
Infections and infestations
Fungal infection
|
2.6%
1/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Infections and infestations
Gastroenteritis
|
10.3%
4/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Infections and infestations
Human herpesvirus 6 infection
|
5.1%
2/39 • 6 months
|
10.5%
4/38 • 6 months
|
|
Infections and infestations
Infection
|
10.3%
4/39 • 6 months
|
13.2%
5/38 • 6 months
|
|
Infections and infestations
Infectious disease carrier
|
15.4%
6/39 • 6 months
|
10.5%
4/38 • 6 months
|
|
Infections and infestations
Oral herpes
|
5.1%
2/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Infections and infestations
Respiratory tract infection
|
2.6%
1/39 • 6 months
|
10.5%
4/38 • 6 months
|
|
Infections and infestations
Rhinitis
|
7.7%
3/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Infections and infestations
Sepsis
|
7.7%
3/39 • 6 months
|
10.5%
4/38 • 6 months
|
|
Infections and infestations
Staphylococcal infection
|
7.7%
3/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Infections and infestations
Wound infection
|
5.1%
2/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Injury, poisoning and procedural complications
Complications of transplanted liver
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Injury, poisoning and procedural complications
Hepatic haematoma
|
5.1%
2/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
5.1%
2/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.1%
2/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Investigations
Antithrombin iii decreased
|
41.0%
16/39 • 6 months
|
42.1%
16/38 • 6 months
|
|
Investigations
Blood magnesium decreased
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Investigations
Blood urea increased
|
2.6%
1/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Investigations
C-reactive protein increased
|
7.7%
3/39 • 6 months
|
18.4%
7/38 • 6 months
|
|
Investigations
Drug level decreased
|
0.00%
0/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Investigations
Immunoglobulins decreased
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Investigations
Platelet count decreased
|
2.6%
1/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Investigations
Red blood cell count decreased
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
|
Investigations
Transaminases increased
|
12.8%
5/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Metabolism and nutrition disorders
Acidosis
|
12.8%
5/39 • 6 months
|
15.8%
6/38 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.5%
8/39 • 6 months
|
39.5%
15/38 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
20.5%
8/39 • 6 months
|
21.1%
8/38 • 6 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
7.7%
3/39 • 6 months
|
10.5%
4/38 • 6 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.1%
2/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.3%
4/39 • 6 months
|
10.5%
4/38 • 6 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
20.5%
8/39 • 6 months
|
39.5%
15/38 • 6 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
10.3%
4/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.5%
8/39 • 6 months
|
34.2%
13/38 • 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
53.8%
21/39 • 6 months
|
39.5%
15/38 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.4%
6/39 • 6 months
|
15.8%
6/38 • 6 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.8%
5/39 • 6 months
|
10.5%
4/38 • 6 months
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
25.6%
10/39 • 6 months
|
13.2%
5/38 • 6 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.6%
1/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Metabolism and nutrition disorders
Vitamin k deficiency
|
7.7%
3/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Nervous system disorders
Headache
|
5.1%
2/39 • 6 months
|
2.6%
1/38 • 6 months
|
|
Psychiatric disorders
Insomnia
|
10.3%
4/39 • 6 months
|
10.5%
4/38 • 6 months
|
|
Psychiatric disorders
Restlessness
|
25.6%
10/39 • 6 months
|
36.8%
14/38 • 6 months
|
|
Renal and urinary disorders
Oliguria
|
5.1%
2/39 • 6 months
|
13.2%
5/38 • 6 months
|
|
Renal and urinary disorders
Renal failure
|
7.7%
3/39 • 6 months
|
15.8%
6/38 • 6 months
|
|
Renal and urinary disorders
Renal failure chronic
|
5.1%
2/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
25.6%
10/39 • 6 months
|
31.6%
12/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
2.6%
1/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
2/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
28.2%
11/39 • 6 months
|
36.8%
14/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
46.2%
18/39 • 6 months
|
63.2%
24/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
7.7%
3/39 • 6 months
|
10.5%
4/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.1%
2/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
2.6%
1/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/39 • 6 months
|
5.3%
2/38 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
3/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Vascular disorders
Hypertension
|
74.4%
29/39 • 6 months
|
71.1%
27/38 • 6 months
|
|
Vascular disorders
Hypotension
|
17.9%
7/39 • 6 months
|
21.1%
8/38 • 6 months
|
|
Vascular disorders
Intra-abdominal haemorrhage
|
2.6%
1/39 • 6 months
|
7.9%
3/38 • 6 months
|
|
Vascular disorders
Vena cava thrombosis
|
5.1%
2/39 • 6 months
|
0.00%
0/38 • 6 months
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER