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Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of immunosuppressive drugs) given in combination with basiliximab, cyclosporine and steroids in pediatric de novo liver transplant recipients. The treatment is compared to the same treatment regimen including intraoperative steroids with respect to rejection episodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With Intraoperative Steroids | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basiliximab | Drug | Basiliximab (10 mg) was supplied as a lyophilisate in vials with ampoules of sterile water for injection (5 mL) and had to be given of 10 mg (body weight <35 kg) or 20 mg (body weight ≥35 kg) strength. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation | 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. | 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigational Site | Various Cities | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Cyclosporine/cyclosporine microemulsion | Drug | Cyclosporine/cyclosporine microemulsion had to be started with 100 mg/m²/day intravenous (i.v) (2x4h) for 7 days and was to be continued i.v. or orally from day 8 onwards as per center practice. During the 6 months treatment period Cyclosporine doses had to be adjusted according to Cyclosporine A (CsA)-trough levels. |
|
|
| Steroid | Drug | Intravenous prednisolone (loading dose: 300 mg/m2, maximum 500 mg) had to be administered intraoperatively only in treatment arm 1 (day 0). The first dose of steroids in treatment arm 2 (day 0) had to be administered within 8 hours after reperfusion of the graft. Beginning from day 1 to day 6 doses of 15 mg/m2/day had to be given intravenously (i.v.) in both treatment arms. Then, the steroid doses (oral prednisone or its equivalent) were to be decreased from 10 mg/m²/day orally (day 7-13), to 7.5 mg/m²/day orally (day 14-30), to 4 mg/m²/day orally (until end of month 2), to 2.5 mg/m²/day orally (until end of month 3) and to 1 mg/m²/day orally (until end of month 6). |
|
| 3 months |
| Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months | 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. | 3 and 6 months |
| Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation | Graft loss is defined as being listed for a re-transplantation. | 3 months and 6 months |
| Number of Participants With Bacterial, Viral and Fungal Infections During Six Months | 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. | 6 months |
| Time of Onset of a First Biopsy Proven Acute Rejection | 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 . | 6 months |
| Percentage of Participants With Treatment Failure Within Three and Six Months | 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. | 3 and 6 months |
| FG001 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation | 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. | safety/Intent to Treat (ITT) population | Posted | Number | Participants | 3 months after treatment |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months | 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. | safety/Intent to Treat (ITT) population | Posted | Number | Participants | 3 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months | 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. | safety/Intent to Treat (ITT) population | Posted | Number | Participants | 3 and 6 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation | Graft loss is defined as being listed for a re-transplantation. | safety/Intent to Treat (ITT) population | Posted | Number | Percentage of participants | 3 months and 6 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Bacterial, Viral and Fungal Infections During Six Months | 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. | Safety Population | Posted | Number | Participants | 6 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Time of Onset of a First Biopsy Proven Acute Rejection | 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 . | safety/Intent to Treat (ITT) population | Posted | Median | 95% Confidence Interval | Months | 6 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Failure Within Three and Six Months | 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. | Intention to treat population | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 and 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 18 | 39 | 39 | 39 | ||
| EG001 | 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. | 23 | 38 | 38 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Coeliac disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ileal fistula | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Device occlusion | General disorders | MedDRA | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA | Systematic Assessment |
| |
| Obstruction | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Biloma | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Chronic hepatic failure | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Haemobilia | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic artery thrombosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic necrosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic vein thrombosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Portal vein stenosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Epstein-barr viraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis astroviral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Anastomotic haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Biliary anastomosis complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Complications of transplanted liver | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Graft complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hepatic haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hepatic rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Epstein-barr virus antibody positive | Investigations | MedDRA | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA | Systematic Assessment |
| |
| Immunosuppressant drug level decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Histiocytosis haematophagic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Bronchomalacia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Diaphragmatic rupture | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hepatopulmonary syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Inferior vena caval occlusion | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Intra-abdominal haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Reperfusion injury | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gingival hyperplasia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA | Systematic Assessment |
| |
| Obstruction | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA | Systematic Assessment |
| |
| Bile duct necrosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic ischaemia | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Pneumobilia | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Portal vein stenosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Epstein-barr virus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Human herpesvirus 6 infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infectious disease carrier | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Complications of transplanted liver | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hepatic haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Antithrombin iii decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA | Systematic Assessment |
| |
| Drug level decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Immunoglobulins decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Vitamin k deficiency | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077552 | Basiliximab |
| D016572 | Cyclosporine |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| from 2 to 16 years |
|
| Male |
|
| Total (N= 39, 38) |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|