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Trial record 4 of 881 for:    Liver Transplant

Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00149994
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : February 14, 2011
Last Update Posted : April 12, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Liver Transplant
Interventions Drug: Cyclosporine A
Drug: Tacrolimus
Drug: Basiliximab
Drug: Methylprednisolone
Drug: Prednisone
Enrollment 171
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cyclosporine A Tacrolimus
Hide Arm/Group Description Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature. Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
Period Title: Overall Study
Started 85 [1] 86
Completed 84 [2] 85
Not Completed 1 1
Reason Not Completed
Administrative problems:             1             0
Protocol Violation             0             1
[1]
"Started" indicates Safety population.
[2]
"Completed" indicates intention to treat (ITT) population.
Arm/Group Title Cyclosporine A Tacrolimus Total
Hide Arm/Group Description Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature. Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature. Total of all reporting groups
Overall Number of Baseline Participants 84 85 169
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 84 participants 85 participants 169 participants
48.1  (12.069) 49.9  (9.886) 48.98  (11.029)
[1]
Measure Description: Baseline measures are based on intention to treat (ITT) population.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 85 participants 169 participants
Female
31
  36.9%
30
  35.3%
61
  36.1%
Male
53
  63.1%
55
  64.7%
108
  63.9%
1.Primary Outcome
Title Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation.
Hide Description A BPAR is defined when the investigator had a suspicion of an acute rejection, where the final clinical diagnosis confirmed the occurrence of an acute rejection, where a biopsy was performed that confirmed the presence of an acute rejection, and where anti-rejection treatment intervention was initiated. The efficacy measured the first rejections (clinically and biopsy proven rejections) at 3 months.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population.
Arm/Group Title Cyclosporine A Tacrolimus
Hide Arm/Group Description:
Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
Overall Number of Participants Analyzed 84 85
Measure Type: Number
Unit of Measure: Percentage of Participants
33.3 32.9
Time Frame Up to 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tacrolimus Cyclosporine A
Hide Arm/Group Description Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature. Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
All-Cause Mortality
Tacrolimus Cyclosporine A
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tacrolimus Cyclosporine A
Affected / at Risk (%) Affected / at Risk (%)
Total   42/86 (48.84%)   33/85 (38.82%) 
Blood and lymphatic system disorders     
Pancytopenia  1  0/86 (0.00%)  1/85 (1.18%) 
Cardiac disorders     
Arrhythmia  1  1/86 (1.16%)  0/85 (0.00%) 
Cardiac arrest  1  1/86 (1.16%)  0/85 (0.00%) 
Myocardial infarction  1  1/86 (1.16%)  0/85 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/86 (1.16%)  0/85 (0.00%) 
Abdominal pain upper  1  1/86 (1.16%)  1/85 (1.18%) 
Ascites  1  0/86 (0.00%)  2/85 (2.35%) 
Constipation  1  0/86 (0.00%)  1/85 (1.18%) 
Crohn's disease  1  0/86 (0.00%)  1/85 (1.18%) 
Diarrhoea  1  0/86 (0.00%)  2/85 (2.35%) 
Gastric haemorrhage  1  0/86 (0.00%)  1/85 (1.18%) 
Gastrointestinal necrosis  1  1/86 (1.16%)  0/85 (0.00%) 
Megacolon  1  1/86 (1.16%)  0/85 (0.00%) 
Nausea  1  2/86 (2.33%)  0/85 (0.00%) 
Pancreatitis  1  0/86 (0.00%)  1/85 (1.18%) 
Truncus coeliacus thrombosis  1  1/86 (1.16%)  0/85 (0.00%) 
Umbilical hernia  1  0/86 (0.00%)  1/85 (1.18%) 
Vomiting  1  3/86 (3.49%)  0/85 (0.00%) 
General disorders     
Chest pain  1  0/86 (0.00%)  1/85 (1.18%) 
Chills  1  1/86 (1.16%)  0/85 (0.00%) 
Malaise  1  0/86 (0.00%)  1/85 (1.18%) 
Pain  1  0/86 (0.00%)  1/85 (1.18%) 
Pyrexia  1  11/86 (12.79%)  4/85 (4.71%) 
Hepatobiliary disorders     
Biliary dilatation  1  0/86 (0.00%)  1/85 (1.18%) 
Biliary ischaemia  1  0/86 (0.00%)  1/85 (1.18%) 
Biloma  1  2/86 (2.33%)  0/85 (0.00%) 
Cholangitis  1  3/86 (3.49%)  2/85 (2.35%) 
Cholestasis  1  0/86 (0.00%)  2/85 (2.35%) 
Hepatic artery thrombosis  1  1/86 (1.16%)  1/85 (1.18%) 
Hepatic failure  1  1/86 (1.16%)  0/85 (0.00%) 
Hepatic haemorrhage  1  1/86 (1.16%)  0/85 (0.00%) 
Hepatic necrosis  1  0/86 (0.00%)  1/85 (1.18%) 
Jaundice  1  1/86 (1.16%)  1/85 (1.18%) 
Liver function test abnormal  1  1/86 (1.16%)  0/85 (0.00%) 
Liver injury  1  0/86 (0.00%)  1/85 (1.18%) 
Portal vein thrombosis  1  2/86 (2.33%)  0/85 (0.00%) 
Immune system disorders     
Graft versus host disease  1  1/86 (1.16%)  0/85 (0.00%) 
Infections and infestations     
Bacteraemia  1  0/86 (0.00%)  1/85 (1.18%) 
Cytomegalovirus colitis  1  0/86 (0.00%)  1/85 (1.18%) 
Cytomegalovirus infection  1  2/86 (2.33%)  0/85 (0.00%) 
Hepatitis C  1  0/86 (0.00%)  1/85 (1.18%) 
Liver abscess  1  1/86 (1.16%)  0/85 (0.00%) 
Pneumonia  1  1/86 (1.16%)  0/85 (0.00%) 
Sepsis  1  2/86 (2.33%)  1/85 (1.18%) 
Septic shock  1  1/86 (1.16%)  1/85 (1.18%) 
Urinary tract infection  1  1/86 (1.16%)  0/85 (0.00%) 
Injury, poisoning and procedural complications     
Biliary anastomosis complication  1  3/86 (3.49%)  3/85 (3.53%) 
Hepatic haematoma  1  1/86 (1.16%)  0/85 (0.00%) 
Post procedural haemorrhage  1  0/86 (0.00%)  1/85 (1.18%) 
Transplant failure  1  0/86 (0.00%)  1/85 (1.18%) 
Investigations     
Hepatic enzyme increased  1  0/86 (0.00%)  1/85 (1.18%) 
Transaminases increased  1  2/86 (2.33%)  1/85 (1.18%) 
Metabolism and nutrition disorders     
Dehydration  1  1/86 (1.16%)  0/85 (0.00%) 
Diabetes mellitus  1  0/86 (0.00%)  1/85 (1.18%) 
Hyperglycaemia  1  0/86 (0.00%)  2/85 (2.35%) 
Hyperkalaemia  1  1/86 (1.16%)  0/85 (0.00%) 
Ketoacidosis  1  0/86 (0.00%)  1/85 (1.18%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/86 (2.33%)  2/85 (2.35%) 
Compartment syndrome  1  1/86 (1.16%)  0/85 (0.00%) 
Musculoskeletal pain  1  1/86 (1.16%)  0/85 (0.00%) 
Nervous system disorders     
Amnesia  1  0/86 (0.00%)  1/85 (1.18%) 
Cerebral haemorrhage  1  1/86 (1.16%)  0/85 (0.00%) 
Convulsion  1  1/86 (1.16%)  0/85 (0.00%) 
Epilepsy  1  0/86 (0.00%)  1/85 (1.18%) 
Neurotoxicity  1  1/86 (1.16%)  0/85 (0.00%) 
Psychiatric disorders     
Completed suicide  1  1/86 (1.16%)  0/85 (0.00%) 
Renal and urinary disorders     
Nephropathy toxic  1  0/86 (0.00%)  2/85 (2.35%) 
Oliguria  1  0/86 (0.00%)  1/85 (1.18%) 
Renal failure  1  1/86 (1.16%)  1/85 (1.18%) 
Renal impairment  1  1/86 (1.16%)  0/85 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Brain hypoxia  1  0/86 (0.00%)  1/85 (1.18%) 
Cough  1  0/86 (0.00%)  1/85 (1.18%) 
Dyspnoea  1  1/86 (1.16%)  2/85 (2.35%) 
Interstitial lung disease  1  0/86 (0.00%)  1/85 (1.18%) 
Pleural effusion  1  1/86 (1.16%)  1/85 (1.18%) 
Pneumonia aspiration  1  2/86 (2.33%)  0/85 (0.00%) 
Respiratory failure  1  1/86 (1.16%)  1/85 (1.18%) 
Stridor  1  1/86 (1.16%)  0/85 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis herpetiformis  1  1/86 (1.16%)  0/85 (0.00%) 
Pruritus  1  1/86 (1.16%)  0/85 (0.00%) 
Rash  1  1/86 (1.16%)  0/85 (0.00%) 
Vascular disorders     
Arterial haemorrhage  1  0/86 (0.00%)  1/85 (1.18%) 
Deep vein thrombosis  1  0/86 (0.00%)  1/85 (1.18%) 
Hypovolaemic shock  1  0/86 (0.00%)  1/85 (1.18%) 
Intra-abdominal haemorrhage  1  0/86 (0.00%)  1/85 (1.18%) 
Shock haemorrhagic  1  1/86 (1.16%)  1/85 (1.18%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tacrolimus Cyclosporine A
Affected / at Risk (%) Affected / at Risk (%)
Total   84/86 (97.67%)   85/85 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  20/86 (23.26%)  28/85 (32.94%) 
Thrombocytopenia  1  5/86 (5.81%)  7/85 (8.24%) 
Cardiac disorders     
Cardiac failure  1  5/86 (5.81%)  4/85 (4.71%) 
Tachycardia  1  5/86 (5.81%)  7/85 (8.24%) 
Gastrointestinal disorders     
Abdominal pain  1  14/86 (16.28%)  24/85 (28.24%) 
Abdominal pain upper  1  10/86 (11.63%)  9/85 (10.59%) 
Ascites  1  29/86 (33.72%)  35/85 (41.18%) 
Constipation  1  26/86 (30.23%)  32/85 (37.65%) 
Diarrhoea  1  26/86 (30.23%)  54/85 (63.53%) 
Dyspepsia  1  4/86 (4.65%)  5/85 (5.88%) 
Ileus  1  6/86 (6.98%)  2/85 (2.35%) 
Impaired gastric emptying  1  2/86 (2.33%)  7/85 (8.24%) 
Nausea  1  40/86 (46.51%)  39/85 (45.88%) 
Vomiting  1  25/86 (29.07%)  26/85 (30.59%) 
General disorders     
Chest pain  1  7/86 (8.14%)  3/85 (3.53%) 
Fatigue  1  8/86 (9.30%)  12/85 (14.12%) 
Oedema  1  41/86 (47.67%)  37/85 (43.53%) 
Pain  1  8/86 (9.30%)  10/85 (11.76%) 
Pyrexia  1  25/86 (29.07%)  33/85 (38.82%) 
Hepatobiliary disorders     
Biloma  1  5/86 (5.81%)  1/85 (1.18%) 
Cholestasis  1  4/86 (4.65%)  8/85 (9.41%) 
Jaundice  1  6/86 (6.98%)  0/85 (0.00%) 
Infections and infestations     
- Unknown Infections -  1  23/86 (26.74%)  18/85 (21.18%) 
Candidiasis  1  23/86 (26.74%)  27/85 (31.76%) 
Clostridial infection  1  5/86 (5.81%)  5/85 (5.88%) 
Cytomegalovirus infection  1  16/86 (18.60%)  14/85 (16.47%) 
Enterobacter infection  1  12/86 (13.95%)  9/85 (10.59%) 
Enterococcal infection  1  28/86 (32.56%)  37/85 (43.53%) 
Epstein-Barr virus infection  1  2/86 (2.33%)  7/85 (8.24%) 
Escherichia infection  1  27/86 (31.40%)  19/85 (22.35%) 
Haemophilus infection  1  1/86 (1.16%)  5/85 (5.88%) 
Herpes simplex  1  3/86 (3.49%)  6/85 (7.06%) 
Infection  1  4/86 (4.65%)  8/85 (9.41%) 
Pneumonia klebsiella  1  9/86 (10.47%)  16/85 (18.82%) 
Pseudomonas infection  1  8/86 (9.30%)  9/85 (10.59%) 
Staphylococcal infection  1  34/86 (39.53%)  33/85 (38.82%) 
Streptococcal infection  1  8/86 (9.30%)  9/85 (10.59%) 
Injury, poisoning and procedural complications     
Biliary anastomosis complication  1  9/86 (10.47%)  7/85 (8.24%) 
Procedural pain  1  22/86 (25.58%)  33/85 (38.82%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  8/86 (9.30%)  15/85 (17.65%) 
Fluid retention  1  8/86 (9.30%)  8/85 (9.41%) 
Hyperglycaemia  1  5/86 (5.81%)  10/85 (11.76%) 
Hyperkalaemia  1  13/86 (15.12%)  8/85 (9.41%) 
Hypokalaemia  1  8/86 (9.30%)  6/85 (7.06%) 
Hypomagnesaemia  1  5/86 (5.81%)  3/85 (3.53%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  16/86 (18.60%)  26/85 (30.59%) 
Myalgia  1  7/86 (8.14%)  9/85 (10.59%) 
Pain in extremity  1  2/86 (2.33%)  5/85 (5.88%) 
Nervous system disorders     
Dizziness  1  8/86 (9.30%)  12/85 (14.12%) 
Headache  1  26/86 (30.23%)  23/85 (27.06%) 
Paraesthesia  1  13/86 (15.12%)  7/85 (8.24%) 
Somnolence  1  5/86 (5.81%)  1/85 (1.18%) 
Tremor  1  12/86 (13.95%)  18/85 (21.18%) 
Psychiatric disorders     
Anxiety  1  7/86 (8.14%)  5/85 (5.88%) 
Delirium  1  9/86 (10.47%)  5/85 (5.88%) 
Insomnia  1  30/86 (34.88%)  46/85 (54.12%) 
Restlessness  1  10/86 (11.63%)  15/85 (17.65%) 
Renal and urinary disorders     
Nephropathy toxic  1  19/86 (22.09%)  24/85 (28.24%) 
Oliguria  1  5/86 (5.81%)  7/85 (8.24%) 
Polyuria  1  16/86 (18.60%)  10/85 (11.76%) 
Renal failure  1  5/86 (5.81%)  4/85 (4.71%) 
Renal impairment  1  7/86 (8.14%)  12/85 (14.12%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  8/86 (9.30%)  4/85 (4.71%) 
Cough  1  6/86 (6.98%)  3/85 (3.53%) 
Dyspnoea  1  19/86 (22.09%)  16/85 (18.82%) 
Oropharyngeal pain  1  6/86 (6.98%)  0/85 (0.00%) 
Pleural effusion  1  24/86 (27.91%)  21/85 (24.71%) 
Respiratory failure  1  5/86 (5.81%)  0/85 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  9/86 (10.47%)  12/85 (14.12%) 
Rash  1  6/86 (6.98%)  5/85 (5.88%) 
Vascular disorders     
Hypertension  1  33/86 (38.37%)  21/85 (24.71%) 
Hypotension  1  7/86 (8.14%)  6/85 (7.06%) 
Intra-abdominal haemorrhage  1  3/86 (3.49%)  6/85 (7.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00149994     History of Changes
Other Study ID Numbers: COLO400ANL07
First Submitted: September 6, 2005
First Posted: September 8, 2005
Results First Submitted: January 25, 2011
Results First Posted: February 14, 2011
Last Update Posted: April 12, 2011