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A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.

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ClinicalTrials.gov Identifier: NCT00545402
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Liver Transplantation
Interventions Drug: Mycophenolate mofetil, adjusted dose
Drug: Tacrolimus
Drug: Corticosteroids, IV
Drug: Mycophenolate mofetil, Standard dose
Drug: Corticosteroids, PO
Enrollment 180
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adjusted Mycophenolate Mofetil (MMF)+Tacrolimus+Corticosteroid Fixed-Dose MMF + Tacrolimus + Corticosteroid (CS)
Hide Arm/Group Description Participants received MMF tablets or capsules, 3 grams per day (g/d), orally (PO), twice daily (BID) with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (area under the concentration-time curve [AUC]) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 nanograms per milliliter (ng/mL) from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an intravenous (IV) bolus of methylprednisolone 10-15 milligrams per kilogram (mg/kg) pre-operative on Day 0 per standard practice of the center. Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Period Title: Overall Study
Started 90 90
Completed 56 61
Not Completed 34 29
Reason Not Completed
Discontinuation of treatment             17             9
Use of unauthorized immunosuppressant             8             7
Death             5             7
Graft loss             2             4
Withdrawal by Subject             0             1
Protocol Violation             1             0
Reason not specified             1             1
Arm/Group Title Adjusted MMF + Tacrolimus + CS Fixed-Dose MMF + Tacrolimus + CS Total
Hide Arm/Group Description Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center. Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment. Total of all reporting groups
Overall Number of Baseline Participants 90 90 180
Hide Baseline Analysis Population Description
Intent to treat (ITT) population includes all randomized participants who received at least 1 dose of MMF.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 90 participants 180 participants
53.4  (8.5) 55.1  (8.3) 54.2  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 90 participants 180 participants
Female
16
  17.8%
19
  21.1%
35
  19.4%
Male
74
  82.2%
71
  78.9%
145
  80.6%
1.Primary Outcome
Title Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant
Hide Description Banff criteria required at least 2 of the 3 following features for a histopathological diagnosis of acute rejection: portal inflammation, bile duct inflammation, and venous endothelial inflammation. Each item was graded from 0 to 3 where 0 equals (=) mild, 2 = moderate, and 3 = severe. The sum of the 3 individual scores, from 0 to 9, corresponded to the Rejection Activity Index (RAI). If RAI = 0, 1, or 2, there was no evidence of rejection. If RAI = 3, there was borderline acute rejection. If RAI = 4 or 5, there was mild acute rejection. If RAI = 6 or 7, there was moderate acute rejection. If RAI = 8 or 9, there was severe acute rejection.
Time Frame Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Adjusted MMF + Tacrolimus + CS Fixed-Dose MMF + Tacrolimus + CS
Hide Arm/Group Description:
Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Overall Number of Participants Analyzed 87 87
Measure Type: Number
Unit of Measure: percentage of participants
8.0 8.2
2.Secondary Outcome
Title Percentage of Participants With Graft Loss
Hide Description Graft survival was defined as the time between the randomization date and the graft loss date. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.
Time Frame Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Adjusted MMF + Tacrolimus + CS Fixed-Dose MMF + Tacrolimus + CS
Hide Arm/Group Description:
Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Overall Number of Participants Analyzed 90 90
Measure Type: Number
Unit of Measure: percentage of participants
2.2 5.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adjusted MMF + Tacrolimus + CS, Fixed-Dose MMF + Tacrolimus + CS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2611
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Graft Survival
Hide Description The median time, in months, between randomization and graft loss event. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.
Time Frame Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Adjusted MMF + Tacrolimus + CS Fixed-Dose MMF + Tacrolimus + CS
Hide Arm/Group Description:
Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Overall Number of Participants Analyzed 90 90
Median (Full Range)
Unit of Measure: months
12.9
(0.0 to 24.5)
12.9
(0.0 to 20.2)
4.Secondary Outcome
Title Overall Survival (OS) at Month 12 - Percentage of Participants With an Event
Hide Description OS was defined as the time between the date of randomization and death up to Month 12. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.
Time Frame Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Adjusted MMF + Tacrolimus + CS Fixed-Dose MMF + Tacrolimus + CS
Hide Arm/Group Description:
Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Overall Number of Participants Analyzed 90 90
Measure Type: Number
Unit of Measure: percentage of participants
8.9 11.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adjusted MMF + Tacrolimus + CS, Fixed-Dose MMF + Tacrolimus + CS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7091
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
5.Secondary Outcome
Title Overall Survival at Month 12
Hide Description The median time, in months, between randomization and OS event. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.
Time Frame Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Adjusted MMF + Tacrolimus + CS Fixed-Dose MMF + Tacrolimus + CS
Hide Arm/Group Description:
Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Overall Number of Participants Analyzed 90 90
Median (Full Range)
Unit of Measure: months
12.9
(0.0 to 24.5)
12.9
(0.1 to 20.2)
6.Secondary Outcome
Title Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review
Hide Description The percentage of participants with biopsies of grafts evaluated by central review and scored according to Banff criteria at Month 12 post-transplant.
Time Frame Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with evaluable biopsies were included in the analysis.
Arm/Group Title Adjusted MMF + Tacrolimus + CS Fixed-Dose MMF + Tacrolimus + CS
Hide Arm/Group Description:
Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Overall Number of Participants Analyzed 42 35
Measure Type: Number
Unit of Measure: percentage of participants
Normal liver 4.8 11.4
Minor lesions 4.8 17.1
Acute rejection 0.0 0.0
Chronic rejection 7.1 2.9
Chronic hepatitis 26.2 22.9
Vascular lesions 35.7 11.4
Pathology of biliary obstruction 4.8 5.7
Lobular hepatitis 4.8 2.9
Recurrence of initial autoimmune disease 0.0 0.0
Other 35.7 45.7
Time Frame Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment.
Adverse Event Reporting Description All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
 
Arm/Group Title Adjusted MMF + Tacrolimus + CS Fixed-Dose MMF + Tacrolimus + CS
Hide Arm/Group Description Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center. Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
All-Cause Mortality
Adjusted MMF + Tacrolimus + CS Fixed-Dose MMF + Tacrolimus + CS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adjusted MMF + Tacrolimus + CS Fixed-Dose MMF + Tacrolimus + CS
Affected / at Risk (%) Affected / at Risk (%)
Total   70/91 (76.92%)   69/92 (75.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/91 (0.00%)  3/92 (3.26%) 
Neutropenia * 1  1/91 (1.10%)  2/92 (2.17%) 
Agranulocytosis * 1  2/91 (2.20%)  0/92 (0.00%) 
Febrile neutropenia * 1  2/91 (2.20%)  0/92 (0.00%) 
Leukopenia * 1  2/91 (2.20%)  0/92 (0.00%) 
Pancytopenia * 1  2/91 (2.20%)  0/92 (0.00%) 
Coagulopathy * 1  0/91 (0.00%)  1/92 (1.09%) 
Haemolytic anaemia * 1  1/91 (1.10%)  0/92 (0.00%) 
Cardiac disorders     
Ventricular tachycardia * 1  1/91 (1.10%)  1/92 (1.09%) 
Cardio-respiratory arrest * 1  1/91 (1.10%)  0/92 (0.00%) 
Cardiogenic shock * 1  1/91 (1.10%)  0/92 (0.00%) 
Myocardial infarction * 1  0/91 (0.00%)  1/92 (1.09%) 
Congenital, familial and genetic disorders     
Hereditary neuropathic amyloidosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Endocrine disorders     
Hyperparathyroidism * 1  0/91 (0.00%)  1/92 (1.09%) 
Gastrointestinal disorders     
Diarrhoea * 1  6/91 (6.59%)  2/92 (2.17%) 
Inguinal hernia * 1  2/91 (2.20%)  4/92 (4.35%) 
Ascites * 1  2/91 (2.20%)  2/92 (2.17%) 
Abdominal hernia * 1  3/91 (3.30%)  0/92 (0.00%) 
Peritonitis * 1  1/91 (1.10%)  2/92 (2.17%) 
Abdominal pain upper * 1  0/91 (0.00%)  2/92 (2.17%) 
Pancreatitis * 1  1/91 (1.10%)  1/92 (1.09%) 
Peritoneal haemorrhage * 1  1/91 (1.10%)  1/92 (1.09%) 
Umbilical hernia * 1  1/91 (1.10%)  1/92 (1.09%) 
Vomiting * 1  2/91 (2.20%)  0/92 (0.00%) 
Abdominal wall haematoma * 1  1/91 (1.10%)  0/92 (0.00%) 
Gastrointestinal disorder * 1  0/91 (0.00%)  1/92 (1.09%) 
Gastrointestinal necrosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Intestinal haemorrhage * 1  1/91 (1.10%)  0/92 (0.00%) 
Intra-abdominal haemorrhage * 1  1/91 (1.10%)  0/92 (0.00%) 
Pancreatitis acute * 1  0/91 (0.00%)  1/92 (1.09%) 
Small intestinal obstruction * 1  1/91 (1.10%)  0/92 (0.00%) 
Volvulus of small bowel * 1  0/91 (0.00%)  1/92 (1.09%) 
General disorders     
Multi-organ failure * 1  5/91 (5.49%)  3/92 (3.26%) 
General physical health deterioration * 1  1/91 (1.10%)  2/92 (2.17%) 
Chest pain * 1  1/91 (1.10%)  1/92 (1.09%) 
Pyrexia * 1  0/91 (0.00%)  2/92 (2.17%) 
Sudden death * 1  0/91 (0.00%)  2/92 (2.17%) 
Hyperthermia * 1  0/91 (0.00%)  1/92 (1.09%) 
Inflammation * 1  1/91 (1.10%)  0/92 (0.00%) 
Malaise * 1  1/91 (1.10%)  0/92 (0.00%) 
Ulcer haemorrhage * 1  1/91 (1.10%)  0/92 (0.00%) 
Hepatobiliary disorders     
Bile duct stenosis * 1  2/91 (2.20%)  4/92 (4.35%) 
Cholangitis * 1  2/91 (2.20%)  4/92 (4.35%) 
Hepatic artery thrombosis * 1  1/91 (1.10%)  5/92 (5.43%) 
Hepatic artery stenosis * 1  3/91 (3.30%)  2/92 (2.17%) 
Biliary fistula * 1  3/91 (3.30%)  1/92 (1.09%) 
Cholestasis * 1  0/91 (0.00%)  4/92 (4.35%) 
Cytolytic hepatitis * 1  0/91 (0.00%)  2/92 (2.17%) 
Bile duct necrosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Biliary cyst * 1  0/91 (0.00%)  1/92 (1.09%) 
Biliary tract disorder * 1  1/91 (1.10%)  0/92 (0.00%) 
Cholelithiasis * 1  1/91 (1.10%)  0/92 (0.00%) 
Hepatic artery aneurysm * 1  1/91 (1.10%)  0/92 (0.00%) 
Hepatic ischaemia * 1  0/91 (0.00%)  1/92 (1.09%) 
Hepatic vein stenosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Portal vein thrombosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Immune system disorders     
Liver transplant rejection * 1  0/91 (0.00%)  1/92 (1.09%) 
Infections and infestations     
Hepatitis C * 1  3/91 (3.30%)  7/92 (7.61%) 
Sepsis * 1  3/91 (3.30%)  4/92 (4.35%) 
Septic shock * 1  4/91 (4.40%)  1/92 (1.09%) 
Peritoneal infection * 1  2/91 (2.20%)  1/92 (1.09%) 
Biliary sepsis * 1  1/91 (1.10%)  1/92 (1.09%) 
Candida sepsis * 1  0/91 (0.00%)  2/92 (2.17%) 
Cytomegalovirus infection * 1  1/91 (1.10%)  1/92 (1.09%) 
Appendicitis * 1  0/91 (0.00%)  1/92 (1.09%) 
Arthritis bacterial * 1  1/91 (1.10%)  0/92 (0.00%) 
Aspergillosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Bacterial sepsis * 1  1/91 (1.10%)  0/92 (0.00%) 
Cytomegalovirus colitis * 1  0/91 (0.00%)  1/92 (1.09%) 
Device related infection * 1  1/91 (1.10%)  0/92 (0.00%) 
Enterocolitis infectious * 1  0/91 (0.00%)  1/92 (1.09%) 
Hepatitis E * 1  1/91 (1.10%)  0/92 (0.00%) 
Herpes zoster * 1  1/91 (1.10%)  0/92 (0.00%) 
Infection * 1  1/91 (1.10%)  0/92 (0.00%) 
Liver abscess * 1  0/91 (0.00%)  1/92 (1.09%) 
Nocardiosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Pneumocystis jiroveci pneumonia * 1  0/91 (0.00%)  1/92 (1.09%) 
Pneumonia * 1  0/91 (0.00%)  1/92 (1.09%) 
Pneumonia cytomegaloviral * 1  1/91 (1.10%)  0/92 (0.00%) 
Systemic candida * 1  1/91 (1.10%)  0/92 (0.00%) 
Urinary tract infection * 1  0/91 (0.00%)  1/92 (1.09%) 
Viral diarrhoea * 1  1/91 (1.10%)  0/92 (0.00%) 
Injury, poisoning and procedural complications     
Biliary anastomosis complication * 1  5/91 (5.49%)  6/92 (6.52%) 
Anastomotic stenosis * 1  0/91 (0.00%)  4/92 (4.35%) 
Graft dysfunction * 1  1/91 (1.10%)  1/92 (1.09%) 
Overdose * 1  0/91 (0.00%)  2/92 (2.17%) 
Wound dehiscence * 1  1/91 (1.10%)  1/92 (1.09%) 
Complications of transplant surgery * 1  0/91 (0.00%)  1/92 (1.09%) 
Complications of transplanted liver * 1  1/91 (1.10%)  0/92 (0.00%) 
Endotracheal intubation complication * 1  1/91 (1.10%)  0/92 (0.00%) 
Femoral neck fracture * 1  0/91 (0.00%)  1/92 (1.09%) 
Graft thrombosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Post procedural haemorrhage * 1  0/91 (0.00%)  1/92 (1.09%) 
Wound evisceration * 1  0/91 (0.00%)  1/92 (1.09%) 
Wound secretion * 1  0/91 (0.00%)  1/92 (1.09%) 
Investigations     
Liver function test abnormal * 1  0/91 (0.00%)  3/92 (3.26%) 
Cytomegalovirus antibody positive * 1  0/91 (0.00%)  1/92 (1.09%) 
Oesophagogastroduodenoscopy * 1  1/91 (1.10%)  0/92 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus * 1  0/91 (0.00%)  3/92 (3.26%) 
Hyperkalaemia * 1  1/91 (1.10%)  2/92 (2.17%) 
Type 1 diabetes mellitus * 1  0/91 (0.00%)  2/92 (2.17%) 
Cell death * 1  1/91 (1.10%)  0/92 (0.00%) 
Diabetes mellitus inadequate control * 1  2/91 (2.20%)  1/92 (1.09%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  0/91 (0.00%)  2/92 (2.17%) 
Musculoskeletal pain * 1  1/91 (1.10%)  0/92 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hepatic neoplasm malignant * 1  0/91 (0.00%)  1/92 (1.09%) 
Lung neoplasm malignant * 1  0/91 (0.00%)  1/92 (1.09%) 
Metastases to bone * 1  0/91 (0.00%)  1/92 (1.09%) 
Metastases to spine * 1  1/91 (1.10%)  0/92 (0.00%) 
Prostate cancer * 1  0/91 (0.00%)  1/92 (1.09%) 
Thyroid neoplasm * 1  1/91 (1.10%)  0/92 (0.00%) 
Nervous system disorders     
Encephalopathy * 1  1/91 (1.10%)  1/92 (1.09%) 
Epilepsy * 1  2/91 (2.20%)  0/92 (0.00%) 
Cerebral haemorrhage * 1  0/91 (0.00%)  1/92 (1.09%) 
Cerebral ischaemia * 1  0/91 (0.00%)  1/92 (1.09%) 
Cerebrovascular accident * 1  1/91 (1.10%)  0/92 (0.00%) 
Coma * 1  0/91 (0.00%)  1/92 (1.09%) 
Convulsion * 1  1/91 (1.10%)  0/92 (0.00%) 
Febrile convulsion * 1  1/91 (1.10%)  0/92 (0.00%) 
Metabolic encephalopathy * 1  1/91 (1.10%)  0/92 (0.00%) 
Neuropathy peripheral * 1  0/91 (0.00%)  1/92 (1.09%) 
Toxic encephalopathy * 1  1/91 (1.10%)  0/92 (0.00%) 
Vocal cord paresis * 1  0/91 (0.00%)  1/92 (1.09%) 
Psychiatric disorders     
Confusional state * 1  2/91 (2.20%)  2/92 (2.17%) 
Mental disorder * 1  1/91 (1.10%)  1/92 (1.09%) 
Delirium * 1  0/91 (0.00%)  1/92 (1.09%) 
Depression * 1  0/91 (0.00%)  1/92 (1.09%) 
Renal and urinary disorders     
Renal failure acute * 1  14/91 (15.38%)  5/92 (5.43%) 
Renal failure * 1  6/91 (6.59%)  6/92 (6.52%) 
Ureteric stenosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Reproductive system and breast disorders     
Prostatitis * 1  0/91 (0.00%)  1/92 (1.09%) 
Testicular torsion * 1  0/91 (0.00%)  1/92 (1.09%) 
Respiratory, thoracic and mediastinal disorders     
Lung disorder * 1  5/91 (5.49%)  4/92 (4.35%) 
Pleural effusion * 1  1/91 (1.10%)  3/92 (3.26%) 
Acute respiratory distress syndrome * 1  2/91 (2.20%)  1/92 (1.09%) 
Pulmonary embolism * 1  2/91 (2.20%)  1/92 (1.09%) 
Bronchopneumopathy * 1  1/91 (1.10%)  0/92 (0.00%) 
Hypoxia * 1  1/91 (1.10%)  0/92 (0.00%) 
Pulmonary oedema * 1  1/91 (1.10%)  0/92 (0.00%) 
Respiratory failure * 1  0/91 (0.00%)  1/92 (1.09%) 
Surgical and medical procedures     
Biliary anastomosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Biliary drainage * 1  1/91 (1.10%)  0/92 (0.00%) 
Catheter removal * 1  0/91 (0.00%)  1/92 (1.09%) 
Surgical vascular shunt * 1  0/91 (0.00%)  1/92 (1.09%) 
Vascular disorders     
Shock haemorrhagic * 1  2/91 (2.20%)  2/92 (2.17%) 
Arterial haemorrhage * 1  1/91 (1.10%)  1/92 (1.09%) 
Aneurysm * 1  1/91 (1.10%)  0/92 (0.00%) 
Angiopathy * 1  1/91 (1.10%)  0/92 (0.00%) 
Arterial stenosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Arterial thrombosis limb * 1  0/91 (0.00%)  1/92 (1.09%) 
Haematoma * 1  0/91 (0.00%)  1/92 (1.09%) 
Haemodynamic instability * 1  0/91 (0.00%)  1/92 (1.09%) 
Jugular vein thrombosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Thrombosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Vascular stenosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Venous thrombosis * 1  1/91 (1.10%)  0/92 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adjusted MMF + Tacrolimus + CS Fixed-Dose MMF + Tacrolimus + CS
Affected / at Risk (%) Affected / at Risk (%)
Total   91/91 (100.00%)   91/92 (98.91%) 
Blood and lymphatic system disorders     
Anaemia * 1  45/91 (49.45%)  44/92 (47.83%) 
Thrombocytopenia * 1  16/91 (17.58%)  13/92 (14.13%) 
Neutropenia * 1  13/91 (14.29%)  6/92 (6.52%) 
Leukopenia * 1  14/91 (15.38%)  2/92 (2.17%) 
Pancytopenia * 1  11/91 (12.09%)  4/92 (4.35%) 
Deficiency anaemia * 1  6/91 (6.59%)  3/92 (3.26%) 
Leukocytosis * 1  1/91 (1.10%)  3/92 (3.26%) 
Lymphopenia * 1  2/91 (2.20%)  1/92 (1.09%) 
Agranulocytosis * 1  2/91 (2.20%)  0/92 (0.00%) 
Disseminated intravascular coagulation * 1  1/91 (1.10%)  1/92 (1.09%) 
Febrile neutropenia * 1  2/91 (2.20%)  0/92 (0.00%) 
Bone marrow failure * 1  0/91 (0.00%)  1/92 (1.09%) 
Coagulopathy * 1  0/91 (0.00%)  1/92 (1.09%) 
Febrile bone marrow aplasia * 1  1/91 (1.10%)  0/92 (0.00%) 
Haemolytic anaemia * 1  1/91 (1.10%)  0/92 (0.00%) 
Idiopathic thrombocytopenic purpura * 1  0/91 (0.00%)  1/92 (1.09%) 
Iron deficiency anaemia * 1  0/91 (0.00%)  1/92 (1.09%) 
Jaundice acholuric * 1  1/91 (1.10%)  0/92 (0.00%) 
Lymphadenopathy * 1  0/91 (0.00%)  1/92 (1.09%) 
Polycythaemia * 1  0/91 (0.00%)  1/92 (1.09%) 
Splenomegaly * 1  0/91 (0.00%)  1/92 (1.09%) 
Thrombocythaemia * 1  1/91 (1.10%)  0/92 (0.00%) 
Thrombotic microangiopathy * 1  0/91 (0.00%)  1/92 (1.09%) 
Cardiac disorders     
Tachycardia * 1  6/91 (6.59%)  1/92 (1.09%) 
Atrial fibrillation * 1  3/91 (3.30%)  3/92 (3.26%) 
Acute coronary syndrome * 1  2/91 (2.20%)  2/92 (2.17%) 
Arrhythmia * 1  0/91 (0.00%)  3/92 (3.26%) 
Bradycardia * 1  2/91 (2.20%)  1/92 (1.09%) 
Pericardial effusion * 1  1/91 (1.10%)  1/92 (1.09%) 
Supraventricular tachycardia * 1  1/91 (1.10%)  1/92 (1.09%) 
Ventricular tachycardia * 1  1/91 (1.10%)  1/92 (1.09%) 
Arrhythmia supraventricular * 1  0/91 (0.00%)  1/92 (1.09%) 
Atrial flutter * 1  1/91 (1.10%)  0/92 (0.00%) 
Cardiac failure * 1  1/91 (1.10%)  0/92 (0.00%) 
Cardio-respiratory arrest * 1  1/91 (1.10%)  0/92 (0.00%) 
Cardiogenic shock * 1  1/91 (1.10%)  0/92 (0.00%) 
Cardiomyopathy * 1  1/91 (1.10%)  0/92 (0.00%) 
Myocardial infarction * 1  0/91 (0.00%)  1/92 (1.09%) 
Palpitations * 1  1/91 (1.10%)  0/92 (0.00%) 
Pericardial disease * 1  1/91 (1.10%)  0/92 (0.00%) 
Stress cardiomyopathy * 1  0/91 (0.00%)  1/92 (1.09%) 
Ventricular extrasystoles * 1  0/91 (0.00%)  1/92 (1.09%) 
Congenital, familial and genetic disorders     
Hereditary neuropathic amyloidosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Hydrocele * 1  1/91 (1.10%)  0/92 (0.00%) 
Ear and labyrinth disorders     
Ear haemorrhage * 1  0/91 (0.00%)  1/92 (1.09%) 
Ear pain * 1  0/91 (0.00%)  1/92 (1.09%) 
Endocrine disorders     
Hyperparathyroidism * 1  0/91 (0.00%)  1/92 (1.09%) 
Hyperthyroidism * 1  1/91 (1.10%)  0/92 (0.00%) 
Eye disorders     
Visual acuity reduced * 1  1/91 (1.10%)  2/92 (2.17%) 
Visual disturbance * 1  1/91 (1.10%)  1/92 (1.09%) 
Uveitis * 1  0/91 (0.00%)  1/92 (1.09%) 
Gastrointestinal disorders     
Diarrhoea * 1  31/91 (34.07%)  26/92 (28.26%) 
Abdominal pain * 1  12/91 (13.19%)  12/92 (13.04%) 
Ascites * 1  9/91 (9.89%)  11/92 (11.96%) 
Constipation * 1  8/91 (8.79%)  11/92 (11.96%) 
Nausea * 1  8/91 (8.79%)  8/92 (8.70%) 
Vomiting * 1  10/91 (10.99%)  5/92 (5.43%) 
Gastrointestinal disorder * 1  2/91 (2.20%)  7/92 (7.61%) 
Inguinal hernia * 1  2/91 (2.20%)  7/92 (7.61%) 
Abdominal pain upper * 1  2/91 (2.20%)  5/92 (5.43%) 
Dyspepsia * 1  2/91 (2.20%)  3/92 (3.26%) 
Peritonitis * 1  2/91 (2.20%)  2/92 (2.17%) 
Abdominal hernia * 1  3/91 (3.30%)  0/92 (0.00%) 
Dysphagia * 1  0/91 (0.00%)  2/92 (2.17%) 
Gastrooesophageal reflux disease * 1  0/91 (0.00%)  2/92 (2.17%) 
Impaired gastric emptying * 1  1/91 (1.10%)  1/92 (1.09%) 
Intra-abdominal haemorrhage * 1  1/91 (1.10%)  1/92 (1.09%) 
Pancreatitis * 1  1/91 (1.10%)  1/92 (1.09%) 
Pancreatitis acute * 1  0/91 (0.00%)  2/92 (2.17%) 
Peritoneal haemorrhage * 1  1/91 (1.10%)  1/92 (1.09%) 
Subileus * 1  2/91 (2.20%)  0/92 (0.00%) 
Umbilical hernia * 1  1/91 (1.10%)  1/92 (1.09%) 
Abdominal wall haematoma * 1  1/91 (1.10%)  0/92 (0.00%) 
Coeliac artery stenosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Colitis * 1  0/91 (0.00%)  1/92 (1.09%) 
Duodenal ulcer * 1  1/91 (1.10%)  0/92 (0.00%) 
Duodenal ulcer haemorrhage * 1  1/91 (1.10%)  0/92 (0.00%) 
Duodenitis * 1  1/91 (1.10%)  0/92 (0.00%) 
Gastric ulcer * 1  1/91 (1.10%)  0/92 (0.00%) 
Gastritis * 1  1/91 (1.10%)  0/92 (0.00%) 
Gastritis erosive * 1  0/91 (0.00%)  1/92 (1.09%) 
Gastrointestinal motility disorder * 1  0/91 (0.00%)  1/92 (1.09%) 
Gastrointestinal necrosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Gastrointestinal pain * 1  1/91 (1.10%)  0/92 (0.00%) 
Haematemesis * 1  0/91 (0.00%)  1/92 (1.09%) 
Haemorrhoids * 1  0/91 (0.00%)  1/92 (1.09%) 
Intestinal haemorrhage * 1  1/91 (1.10%)  0/92 (0.00%) 
Intestinal obstruction * 1  1/91 (1.10%)  0/92 (0.00%) 
Melaena * 1  0/91 (0.00%)  1/92 (1.09%) 
Oesophageal ulcer * 1  1/91 (1.10%)  0/92 (0.00%) 
Oesophagitis * 1  1/91 (1.10%)  0/92 (0.00%) 
Oesophagitis ulcerative * 1  0/91 (0.00%)  1/92 (1.09%) 
Peritoneal effusion * 1  0/91 (0.00%)  1/92 (1.09%) 
Pneumoperitoneum * 1  1/91 (1.10%)  0/92 (0.00%) 
Portal venous gas * 1  1/91 (1.10%)  0/92 (0.00%) 
Small bowel angioedema * 1  0/91 (0.00%)  1/92 (1.09%) 
Small intestinal obstruction * 1  1/91 (1.10%)  0/92 (0.00%) 
Stomatitis * 1  1/91 (1.10%)  0/92 (0.00%) 
Toothache * 1  1/91 (1.10%)  0/92 (0.00%) 
Volvulus of small bowel * 1  0/91 (0.00%)  1/92 (1.09%) 
General disorders     
Oedema peripheral * 1  10/91 (10.99%)  17/92 (18.48%) 
Pain * 1  12/91 (13.19%)  10/92 (10.87%) 
Pyrexia * 1  11/91 (12.09%)  4/92 (4.35%) 
Hyperthermia * 1  8/91 (8.79%)  5/92 (5.43%) 
Oedema * 1  7/91 (7.69%)  5/92 (5.43%) 
Multi-organ failure * 1  5/91 (5.49%)  5/92 (5.43%) 
Asthenia * 1  2/91 (2.20%)  6/92 (6.52%) 
Inflammation * 1  2/91 (2.20%)  5/92 (5.43%) 
Chest pain * 1  2/91 (2.20%)  2/92 (2.17%) 
General physical health deterioration * 1  1/91 (1.10%)  2/92 (2.17%) 
Hypothermia * 1  1/91 (1.10%)  2/92 (2.17%) 
Effusion * 1  2/91 (2.20%)  0/92 (0.00%) 
Influenza like illness * 1  1/91 (1.10%)  1/92 (1.09%) 
Sudden death * 1  0/91 (0.00%)  2/92 (2.17%) 
Catheter site necrosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Chills * 1  0/91 (0.00%)  1/92 (1.09%) 
Generalised oedema * 1  1/91 (1.10%)  0/92 (0.00%) 
Malaise * 1  1/91 (1.10%)  0/92 (0.00%) 
Necrosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Polyp * 1  1/91 (1.10%)  0/92 (0.00%) 
Ulcer * 1  1/91 (1.10%)  0/92 (0.00%) 
Ulcer haemorrhage * 1  1/91 (1.10%)  0/92 (0.00%) 
Hepatobiliary disorders     
Cholestasis * 1  24/91 (26.37%)  19/92 (20.65%) 
Cholangitis * 1  5/91 (5.49%)  6/92 (6.52%) 
Bile duct stenosis * 1  4/91 (4.40%)  4/92 (4.35%) 
Hepatic artery thrombosis * 1  1/91 (1.10%)  7/92 (7.61%) 
Cytolytic hepatitis * 1  4/91 (4.40%)  3/92 (3.26%) 
Hepatic artery stenosis * 1  4/91 (4.40%)  3/92 (3.26%) 
Jaundice * 1  5/91 (5.49%)  2/92 (2.17%) 
Biliary fistula * 1  3/91 (3.30%)  3/92 (3.26%) 
Portal vein thrombosis * 1  5/91 (5.49%)  1/92 (1.09%) 
Biloma * 1  2/91 (2.20%)  2/92 (2.17%) 
Biliary tract disorder * 1  2/91 (2.20%)  1/92 (1.09%) 
Hepatic function abnormal * 1  1/91 (1.10%)  2/92 (2.17%) 
Biliary cyst * 1  1/91 (1.10%)  1/92 (1.09%) 
Hepatic cirrhosis * 1  2/91 (2.20%)  0/92 (0.00%) 
Hepatic failure * 1  0/91 (0.00%)  2/92 (2.17%) 
Hyperbilirubinaemia * 1  2/91 (2.20%)  0/92 (0.00%) 
Bile duct necrosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Cholelithiasis * 1  1/91 (1.10%)  0/92 (0.00%) 
Hepatic artery aneurysm * 1  1/91 (1.10%)  0/92 (0.00%) 
Hepatic ischaemia * 1  0/91 (0.00%)  1/92 (1.09%) 
Hepatic vein stenosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Hepatitis cholestatic * 1  1/91 (1.10%)  0/92 (0.00%) 
Hepatorenal syndrome * 1  1/91 (1.10%)  0/92 (0.00%) 
Immune system disorders     
Drug hypersensitivity * 1  1/91 (1.10%)  3/92 (3.26%) 
Hypersensitivity * 1  0/91 (0.00%)  1/92 (1.09%) 
Liver transplant rejection * 1  0/91 (0.00%)  1/92 (1.09%) 
Transplant rejection * 1  0/91 (0.00%)  1/92 (1.09%) 
Infections and infestations     
Urinary tract infection * 1  13/91 (14.29%)  14/92 (15.22%) 
Hepatitis C * 1  7/91 (7.69%)  11/92 (11.96%) 
Sepsis * 1  9/91 (9.89%)  8/92 (8.70%) 
Cytomegalovirus infection * 1  7/91 (7.69%)  6/92 (6.52%) 
Staphylococcal infection * 1  4/91 (4.40%)  6/92 (6.52%) 
Bronchitis * 1  2/91 (2.20%)  5/92 (5.43%) 
Septic shock * 1  4/91 (4.40%)  2/92 (2.17%) 
Infection * 1  4/91 (4.40%)  1/92 (1.09%) 
Puncture site infection * 1  3/91 (3.30%)  2/92 (2.17%) 
Abdominal wall abscess * 1  2/91 (2.20%)  2/92 (2.17%) 
Ascites infection * 1  2/91 (2.20%)  2/92 (2.17%) 
Enterococcal infection * 1  4/91 (4.40%)  0/92 (0.00%) 
Lung infection * 1  3/91 (3.30%)  1/92 (1.09%) 
Peritoneal infection * 1  3/91 (3.30%)  1/92 (1.09%) 
Nasopharyngitis * 1  1/91 (1.10%)  2/92 (2.17%) 
Oral candidiasis * 1  0/91 (0.00%)  3/92 (3.26%) 
Staphylococcal sepsis * 1  1/91 (1.10%)  2/92 (2.17%) 
Tonsillitis * 1  2/91 (2.20%)  1/92 (1.09%) 
Arthritis bacterial * 1  1/91 (1.10%)  1/92 (1.09%) 
Biliary sepsis * 1  1/91 (1.10%)  1/92 (1.09%) 
Candida sepsis * 1  0/91 (0.00%)  2/92 (2.17%) 
Catheter related infection * 1  0/91 (0.00%)  2/92 (2.17%) 
Clostridial infection * 1  1/91 (1.10%)  1/92 (1.09%) 
Device related infection * 1  1/91 (1.10%)  1/92 (1.09%) 
Fungal infection * 1  1/91 (1.10%)  1/92 (1.09%) 
Gastroenteritis viral * 1  1/91 (1.10%)  1/92 (1.09%) 
Herpes zoster * 1  1/91 (1.10%)  1/92 (1.09%) 
Postoperative wound infection * 1  1/91 (1.10%)  1/92 (1.09%) 
Streptococcal infection * 1  1/91 (1.10%)  1/92 (1.09%) 
Abscess * 1  1/91 (1.10%)  0/92 (0.00%) 
Appendicitis * 1  0/91 (0.00%)  1/92 (1.09%) 
Aspergillosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Bacterial infection * 1  1/91 (1.10%)  0/92 (0.00%) 
Bacterial sepsis * 1  1/91 (1.10%)  0/92 (0.00%) 
Bronchopulmonary aspergillosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Candidiasis * 1  1/91 (1.10%)  0/92 (0.00%) 
Cellulitis * 1  1/91 (1.10%)  0/92 (0.00%) 
Cholecystitis infective * 1  0/91 (0.00%)  1/92 (1.09%) 
Citrobacter infection * 1  1/91 (1.10%)  0/92 (0.00%) 
Clostridium difficile colitis * 1  1/91 (1.10%)  0/92 (0.00%) 
Cystitis * 1  0/91 (0.00%)  1/92 (1.09%) 
Cytomegalovirus colitis * 1  0/91 (0.00%)  1/92 (1.09%) 
Cytomegalovirus viraemia * 1  0/91 (0.00%)  1/92 (1.09%) 
Endocarditis * 1  0/91 (0.00%)  1/92 (1.09%) 
Enterobacter bacteraemia * 1  0/91 (0.00%)  1/92 (1.09%) 
Enterocolitis infectious * 1  0/91 (0.00%)  1/92 (1.09%) 
Furuncle * 1  0/91 (0.00%)  1/92 (1.09%) 
Hepatitis E * 1  1/91 (1.10%)  0/92 (0.00%) 
Hepatobiliary infection * 1  0/91 (0.00%)  1/92 (1.09%) 
Herpes simplex * 1  0/91 (0.00%)  1/92 (1.09%) 
Influenza * 1  1/91 (1.10%)  0/92 (0.00%) 
Infusion site infection * 1  1/91 (1.10%)  0/92 (0.00%) 
Liver abscess * 1  0/91 (0.00%)  1/92 (1.09%) 
Nocardiosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Oesophageal candidiasis * 1  1/91 (1.10%)  0/92 (0.00%) 
Oral fungal infection * 1  1/91 (1.10%)  0/92 (0.00%) 
Orchitis * 1  0/91 (0.00%)  1/92 (1.09%) 
Paronychia * 1  1/91 (1.10%)  0/92 (0.00%) 
Pneumocystis jiroveci pneumonia * 1  0/91 (0.00%)  1/92 (1.09%) 
Pneumonia * 1  0/91 (0.00%)  1/92 (1.09%) 
Pneumonia cytomegaloviral * 1  1/91 (1.10%)  0/92 (0.00%) 
Pseudomonal sepsis * 1  1/91 (1.10%)  0/92 (0.00%) 
Rhinitis * 1  0/91 (0.00%)  1/92 (1.09%) 
Serratia infection * 1  0/91 (0.00%)  1/92 (1.09%) 
Skin infection * 1  1/91 (1.10%)  0/92 (0.00%) 
Staphylococcal bacteraemia * 1  0/91 (0.00%)  1/92 (1.09%) 
Systemic candida * 1  1/91 (1.10%)  0/92 (0.00%) 
Viral diarrhoea * 1  1/91 (1.10%)  0/92 (0.00%) 
Injury, poisoning and procedural complications     
Biliary anastomosis complication * 1  7/91 (7.69%)  6/92 (6.52%) 
Seroma * 1  4/91 (4.40%)  5/92 (5.43%) 
Overdose * 1  1/91 (1.10%)  6/92 (6.52%) 
Anastomotic stenosis * 1  2/91 (2.20%)  4/92 (4.35%) 
Eschar * 1  3/91 (3.30%)  1/92 (1.09%) 
Hepatic haematoma * 1  1/91 (1.10%)  3/92 (3.26%) 
Procedural pain * 1  4/91 (4.40%)  0/92 (0.00%) 
Wound dehiscence * 1  3/91 (3.30%)  1/92 (1.09%) 
Accidental overdose * 1  3/91 (3.30%)  0/92 (0.00%) 
Graft dysfunction * 1  2/91 (2.20%)  1/92 (1.09%) 
Operative haemorrhage * 1  1/91 (1.10%)  2/92 (2.17%) 
Endotracheal intubation complication * 1  2/91 (2.20%)  0/92 (0.00%) 
Complications of transplant surgery * 1  0/91 (0.00%)  1/92 (1.09%) 
Complications of transplanted liver * 1  1/91 (1.10%)  0/92 (0.00%) 
Facial bones fracture * 1  0/91 (0.00%)  1/92 (1.09%) 
Fall * 1  0/91 (0.00%)  1/92 (1.09%) 
Femoral neck fracture * 1  0/91 (0.00%)  1/92 (1.09%) 
Foot fracture * 1  1/91 (1.10%)  0/92 (0.00%) 
Graft thrombosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Poisoning * 1  0/91 (0.00%)  1/92 (1.09%) 
Post procedural haemorrhage * 1  0/91 (0.00%)  1/92 (1.09%) 
Radiation leukopenia * 1  1/91 (1.10%)  0/92 (0.00%) 
Radiation oesophagitis * 1  1/91 (1.10%)  0/92 (0.00%) 
Rib fracture * 1  0/91 (0.00%)  1/92 (1.09%) 
Spinal compression fracture * 1  0/91 (0.00%)  1/92 (1.09%) 
Surgical procedure repeated * 1  1/91 (1.10%)  0/92 (0.00%) 
Thoracic vertebral fracture * 1  0/91 (0.00%)  1/92 (1.09%) 
Tooth fracture * 1  0/91 (0.00%)  1/92 (1.09%) 
Wound * 1  1/91 (1.10%)  0/92 (0.00%) 
Wound evisceration * 1  0/91 (0.00%)  1/92 (1.09%) 
Wound secretion * 1  0/91 (0.00%)  1/92 (1.09%) 
Investigations     
Band neutrophil percentage decreased * 1  4/91 (4.40%)  5/92 (5.43%) 
Weight decreased * 1  4/91 (4.40%)  5/92 (5.43%) 
Red blood cell count decreased * 1  3/91 (3.30%)  4/92 (4.35%) 
Liver function test abnormal * 1  1/91 (1.10%)  5/92 (5.43%) 
Weight increased * 1  3/91 (3.30%)  2/92 (2.17%) 
Gamma-glutamyltransferase increased * 1  3/91 (3.30%)  1/92 (1.09%) 
Blood bilirubin increased * 1  2/91 (2.20%)  1/92 (1.09%) 
Blood urea increased * 1  2/91 (2.20%)  1/92 (1.09%) 
Haematology test abnormal * 1  0/91 (0.00%)  2/92 (2.17%) 
Aspiration tracheal * 1  1/91 (1.10%)  0/92 (0.00%) 
Blood glucose * 1  1/91 (1.10%)  0/92 (0.00%) 
Cytomegalovirus antibody positive * 1  0/91 (0.00%)  1/92 (1.09%) 
Oesophagogastroduodenoscopy * 1  1/91 (1.10%)  0/92 (0.00%) 
Prothrombin level decreased * 1  1/91 (1.10%)  0/92 (0.00%) 
Serum ferritin increased * 1  0/91 (0.00%)  1/92 (1.09%) 
Metabolism and nutrition disorders     
Hyperkalaemia * 1  15/91 (16.48%)  14/92 (15.22%) 
Diabetes mellitus * 1  6/91 (6.59%)  19/92 (20.65%) 
Hyperglycaemia * 1  11/91 (12.09%)  13/92 (14.13%) 
Cell death * 1  12/91 (13.19%)  8/92 (8.70%) 
Hypokalaemia * 1  5/91 (5.49%)  8/92 (8.70%) 
Diabetes mellitus inadequate control * 1  5/91 (5.49%)  3/92 (3.26%) 
Dyslipidaemia * 1  1/91 (1.10%)  5/92 (5.43%) 
Type 1 diabetes mellitus * 1  1/91 (1.10%)  4/92 (4.35%) 
Anorexia * 1  2/91 (2.20%)  2/92 (2.17%) 
Hypomagnesaemia * 1  2/91 (2.20%)  2/92 (2.17%) 
Hypercalcaemia * 1  2/91 (2.20%)  1/92 (1.09%) 
Hypercholesterolaemia * 1  0/91 (0.00%)  3/92 (3.26%) 
Hypoalbuminaemia * 1  1/91 (1.10%)  2/92 (2.17%) 
Acidosis * 1  1/91 (1.10%)  1/92 (1.09%) 
Electrolyte imbalance * 1  0/91 (0.00%)  2/92 (2.17%) 
Hypocalcaemia * 1  1/91 (1.10%)  1/92 (1.09%) 
Hypoglycaemia * 1  0/91 (0.00%)  2/92 (2.17%) 
Iron deficiency * 1  0/91 (0.00%)  2/92 (2.17%) 
Metabolic acidosis * 1  1/91 (1.10%)  1/92 (1.09%) 
Weight fluctuation * 1  1/91 (1.10%)  1/92 (1.09%) 
Cachexia * 1  1/91 (1.10%)  0/92 (0.00%) 
Decreased appetite * 1  0/91 (0.00%)  1/92 (1.09%) 
Dehydration * 1  1/91 (1.10%)  0/92 (0.00%) 
Fluid overload * 1  0/91 (0.00%)  1/92 (1.09%) 
Gout * 1  1/91 (1.10%)  0/92 (0.00%) 
Hypernatraemia * 1  0/91 (0.00%)  1/92 (1.09%) 
Hypertriglyceridaemia * 1  0/91 (0.00%)  1/92 (1.09%) 
Hyponatraemia * 1  0/91 (0.00%)  1/92 (1.09%) 
Hypovitaminosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Lactic acidosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Metabolic syndrome * 1  1/91 (1.10%)  0/92 (0.00%) 
Mineral deficiency * 1  0/91 (0.00%)  1/92 (1.09%) 
Phlebitis * 1  0/91 (0.00%)  1/92 (1.09%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  7/91 (7.69%)  7/92 (7.61%) 
Muscle spasms * 1  5/91 (5.49%)  4/92 (4.35%) 
Osteopenia * 1  3/91 (3.30%)  1/92 (1.09%) 
Osteoporosis * 1  1/91 (1.10%)  3/92 (3.26%) 
Pain in extremity * 1  3/91 (3.30%)  1/92 (1.09%) 
Osteoarthritis * 1  0/91 (0.00%)  3/92 (3.26%) 
Arthralgia * 1  1/91 (1.10%)  1/92 (1.09%) 
Hypercreatinaemia * 1  1/91 (1.10%)  1/92 (1.09%) 
Musculoskeletal pain * 1  1/91 (1.10%)  1/92 (1.09%) 
Amyotrophy * 1  1/91 (1.10%)  0/92 (0.00%) 
Bursitis * 1  1/91 (1.10%)  0/92 (0.00%) 
Intervertebral disc protrusion * 1  0/91 (0.00%)  1/92 (1.09%) 
Muscle haemorrhage * 1  0/91 (0.00%)  1/92 (1.09%) 
Musculoskeletal chest pain * 1  0/91 (0.00%)  1/92 (1.09%) 
Myalgia * 1  0/91 (0.00%)  1/92 (1.09%) 
Neck pain * 1  0/91 (0.00%)  1/92 (1.09%) 
Spinal osteoarthritis * 1  0/91 (0.00%)  1/92 (1.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  1/91 (1.10%)  0/92 (0.00%) 
Hepatic neoplasm malignant * 1  0/91 (0.00%)  1/92 (1.09%) 
Lung neoplasm malignant * 1  0/91 (0.00%)  1/92 (1.09%) 
Metastases to bone * 1  0/91 (0.00%)  1/92 (1.09%) 
Metastases to spine * 1  1/91 (1.10%)  0/92 (0.00%) 
Prostate cancer * 1  0/91 (0.00%)  1/92 (1.09%) 
Thyroid neoplasm * 1  1/91 (1.10%)  0/92 (0.00%) 
Nervous system disorders     
Headache * 1  9/91 (9.89%)  10/92 (10.87%) 
Tremor * 1  8/91 (8.79%)  9/92 (9.78%) 
Convulsion * 1  1/91 (1.10%)  4/92 (4.35%) 
Febrile convulsion * 1  4/91 (4.40%)  1/92 (1.09%) 
Encephalopathy * 1  3/91 (3.30%)  1/92 (1.09%) 
Dizziness * 1  1/91 (1.10%)  2/92 (2.17%) 
Dysarthria * 1  1/91 (1.10%)  2/92 (2.17%) 
Epilepsy * 1  2/91 (2.20%)  1/92 (1.09%) 
Paraesthesia * 1  1/91 (1.10%)  2/92 (2.17%) 
Syncope vasovagal * 1  3/91 (3.30%)  0/92 (0.00%) 
Amnesia * 1  1/91 (1.10%)  1/92 (1.09%) 
Carpal tunnel syndrome * 1  1/91 (1.10%)  1/92 (1.09%) 
Ischaemic stroke * 1  1/91 (1.10%)  1/92 (1.09%) 
Polyneuropathy * 1  1/91 (1.10%)  1/92 (1.09%) 
Somnolence * 1  0/91 (0.00%)  2/92 (2.17%) 
Altered state of consciousness * 1  1/91 (1.10%)  0/92 (0.00%) 
Aphonia * 1  0/91 (0.00%)  1/92 (1.09%) 
Cerebral haemorrhage * 1  0/91 (0.00%)  1/92 (1.09%) 
Cerebral ischaemia * 1  0/91 (0.00%)  1/92 (1.09%) 
Cerebrovascular accident * 1  1/91 (1.10%)  0/92 (0.00%) 
Cognitive disorder * 1  1/91 (1.10%)  0/92 (0.00%) 
Coma * 1  0/91 (0.00%)  1/92 (1.09%) 
Depressed level of consciousness * 1  0/91 (0.00%)  1/92 (1.09%) 
Hyperreflexia * 1  0/91 (0.00%)  1/92 (1.09%) 
Memory impairment * 1  0/91 (0.00%)  1/92 (1.09%) 
Metabolic encephalopathy * 1  1/91 (1.10%)  0/92 (0.00%) 
Neuropathy peripheral * 1  0/91 (0.00%)  1/92 (1.09%) 
Paresis * 1  0/91 (0.00%)  1/92 (1.09%) 
Psychomotor skills impaired * 1  1/91 (1.10%)  0/92 (0.00%) 
Subarachnoid haemorrhage * 1  0/91 (0.00%)  1/92 (1.09%) 
Toxic encephalopathy * 1  1/91 (1.10%)  0/92 (0.00%) 
Vocal cord paralysis * 1  1/91 (1.10%)  0/92 (0.00%) 
Vocal cord paresis * 1  0/91 (0.00%)  1/92 (1.09%) 
Psychiatric disorders     
Confusional state * 1  11/91 (12.09%)  14/92 (15.22%) 
Insomnia * 1  15/91 (16.48%)  10/92 (10.87%) 
Agitation * 1  8/91 (8.79%)  8/92 (8.70%) 
Anxiety * 1  4/91 (4.40%)  12/92 (13.04%) 
Depression * 1  1/91 (1.10%)  6/92 (6.52%) 
Delirium * 1  0/91 (0.00%)  2/92 (2.17%) 
Mental disorder * 1  1/91 (1.10%)  1/92 (1.09%) 
Affective disorder * 1  0/91 (0.00%)  1/92 (1.09%) 
Hallucination * 1  0/91 (0.00%)  1/92 (1.09%) 
Hallucination, visual * 1  1/91 (1.10%)  0/92 (0.00%) 
Sleep disorder * 1  0/91 (0.00%)  1/92 (1.09%) 
Renal and urinary disorders     
Renal failure * 1  24/91 (26.37%)  23/92 (25.00%) 
Renal failure acute * 1  22/91 (24.18%)  16/92 (17.39%) 
Renal impairment * 1  6/91 (6.59%)  8/92 (8.70%) 
Oliguria * 1  4/91 (4.40%)  5/92 (5.43%) 
Anuria * 1  1/91 (1.10%)  1/92 (1.09%) 
Dysuria * 1  0/91 (0.00%)  2/92 (2.17%) 
Micturition disorder * 1  0/91 (0.00%)  1/92 (1.09%) 
Polyuria * 1  0/91 (0.00%)  1/92 (1.09%) 
Renal colic * 1  0/91 (0.00%)  1/92 (1.09%) 
Renal pain * 1  0/91 (0.00%)  1/92 (1.09%) 
Renal tubular disorder * 1  1/91 (1.10%)  0/92 (0.00%) 
Ureteric stenosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Urinary incontinence * 1  0/91 (0.00%)  1/92 (1.09%) 
Urinary retention * 1  0/91 (0.00%)  1/92 (1.09%) 
Reproductive system and breast disorders     
Prostatitis * 1  0/91 (0.00%)  2/92 (2.17%) 
Benign prostatic hyperplasia * 1  0/91 (0.00%)  1/92 (1.09%) 
Oedema genital * 1  1/91 (1.10%)  0/92 (0.00%) 
Ovarian cyst * 1  1/91 (1.10%)  0/92 (0.00%) 
Pruritus genital * 1  0/91 (0.00%)  1/92 (1.09%) 
Testicular torsion * 1  0/91 (0.00%)  1/92 (1.09%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  22/91 (24.18%)  25/92 (27.17%) 
Lung disorder * 1  13/91 (14.29%)  9/92 (9.78%) 
Cough * 1  5/91 (5.49%)  1/92 (1.09%) 
Dyspnoea * 1  3/91 (3.30%)  3/92 (3.26%) 
Acute respiratory distress syndrome * 1  3/91 (3.30%)  1/92 (1.09%) 
Atelectasis * 1  2/91 (2.20%)  2/92 (2.17%) 
Hypoxia * 1  3/91 (3.30%)  1/92 (1.09%) 
Acute pulmonary oedema * 1  3/91 (3.30%)  0/92 (0.00%) 
Pulmonary embolism * 1  2/91 (2.20%)  1/92 (1.09%) 
Respiratory distress * 1  1/91 (1.10%)  2/92 (2.17%) 
Bronchial obstruction * 1  1/91 (1.10%)  1/92 (1.09%) 
Bronchopneumopathy * 1  1/91 (1.10%)  1/92 (1.09%) 
Respiratory failure * 1  1/91 (1.10%)  1/92 (1.09%) 
Dyspnoea exertional * 1  0/91 (0.00%)  1/92 (1.09%) 
Epistaxis * 1  0/91 (0.00%)  1/92 (1.09%) 
Hydropneumothorax * 1  0/91 (0.00%)  1/92 (1.09%) 
Hydrothorax * 1  1/91 (1.10%)  0/92 (0.00%) 
Pneumothorax * 1  1/91 (1.10%)  0/92 (0.00%) 
Pulmonary oedema * 1  1/91 (1.10%)  0/92 (0.00%) 
Respiratory gas exchange disorder * 1  1/91 (1.10%)  0/92 (0.00%) 
Rhinorrhoea * 1  1/91 (1.10%)  0/92 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  8/91 (8.79%)  3/92 (3.26%) 
Skin necrosis * 1  1/91 (1.10%)  4/92 (4.35%) 
Erythema * 1  2/91 (2.20%)  1/92 (1.09%) 
Dermatitis exfoliative * 1  0/91 (0.00%)  1/92 (1.09%) 
Rash * 1  0/91 (0.00%)  1/92 (1.09%) 
Scar pain * 1  0/91 (0.00%)  1/92 (1.09%) 
Skin lesion * 1  0/91 (0.00%)  1/92 (1.09%) 
Urticaria * 1  0/91 (0.00%)  1/92 (1.09%) 
Vascular purpura * 1  1/91 (1.10%)  0/92 (0.00%) 
Social circumstances     
Alcohol use * 1  0/91 (0.00%)  1/92 (1.09%) 
Surgical and medical procedures     
Biliary anastomosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Biliary drainage * 1  1/91 (1.10%)  0/92 (0.00%) 
Catheter removal * 1  0/91 (0.00%)  1/92 (1.09%) 
Skin neoplasm excision * 1  1/91 (1.10%)  0/92 (0.00%) 
Surgical vascular shunt * 1  0/91 (0.00%)  1/92 (1.09%) 
Vascular disorders     
Hypertension * 1  31/91 (34.07%)  31/92 (33.70%) 
Venous thrombosis * 1  7/91 (7.69%)  4/92 (4.35%) 
Haemodynamic instability * 1  3/91 (3.30%)  7/92 (7.61%) 
Haemorrhage * 1  3/91 (3.30%)  4/92 (4.35%) 
Hypotension * 1  3/91 (3.30%)  3/92 (3.26%) 
Haematoma * 1  2/91 (2.20%)  2/92 (2.17%) 
Shock haemorrhagic * 1  2/91 (2.20%)  2/92 (2.17%) 
Arterial haemorrhage * 1  1/91 (1.10%)  1/92 (1.09%) 
Vein discolouration * 1  1/91 (1.10%)  1/92 (1.09%) 
Aneurysm * 1  1/91 (1.10%)  0/92 (0.00%) 
Angiopathy * 1  1/91 (1.10%)  0/92 (0.00%) 
Arterial stenosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Arterial thrombosis limb * 1  0/91 (0.00%)  1/92 (1.09%) 
Hypovolaemic shock * 1  0/91 (0.00%)  1/92 (1.09%) 
Jugular vein thrombosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Lymphoedema * 1  1/91 (1.10%)  0/92 (0.00%) 
Orthostatic hypotension * 1  0/91 (0.00%)  1/92 (1.09%) 
Thrombophlebitis * 1  0/91 (0.00%)  1/92 (1.09%) 
Thrombosis * 1  1/91 (1.10%)  0/92 (0.00%) 
Vascular stenosis * 1  0/91 (0.00%)  1/92 (1.09%) 
Venous stasis * 1  1/91 (1.10%)  0/92 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
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Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545402     History of Changes
Other Study ID Numbers: ML21273
First Submitted: October 16, 2007
First Posted: October 17, 2007
Results First Submitted: June 9, 2014
Results First Posted: July 14, 2014
Last Update Posted: July 14, 2014