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Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant (A-WISH)

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ClinicalTrials.gov Identifier: NCT00135694
Recruitment Status : Completed
First Posted : August 26, 2005
Results First Posted : December 8, 2016
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C
Hepatitis C, Chronic
Nonimmune Nonviral Causes of Liver Failure
Interventions Drug: calcineurin inhibitor-based immunosuppression
Procedure: liver transplant
Drug: corticosteroids
Other: immunosuppression withdrawal
Enrollment 275
Recruitment Details Participants with liver failure due to hepatitis C infection or non-immune, non-viral causes were enrolled between October 2005 and April 2011.
Pre-assignment Details Participants 12-24 months post-transplant, stable on immunosuppression monotherapy for at least 3 months prior to random assignment, with stage 2 or less fibrosis on the Ishak scale, adequate hepatic and renal function, and no biopsy-proven rejection were randomized between November 2006 and December 2012.
Arm/Group Title Terminated Prior to Randomization Randomized to Immunosuppression Withdrawal Randomized to Immunosuppression Maintenance
Hide Arm/Group Description Subjects enrolled and transplanted into the trial but not eligible for randomization. Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal. Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
Period Title: Overall Study
Started 180 77 18
Completed 0 [1] 56 11
Not Completed 180 21 7
Reason Not Completed
Adverse Event             17             4             0
Death             14             1             2
Lost to Follow-up             8             7             1
Withdrawal by Subject             41             7             4
Protocol Violation             19             1             0
Hepatitis C related reasons             39             1             0
Ineligible for Random assignment             42             0             0
[1]
Subjects were assessed as ineligible for random assignment and subsequently terminated per protocol.
Arm/Group Title Terminated Prior to Randomization Randomized to Immunosuppression Withdrawal Randomized to Immunosuppression Maintenance Total
Hide Arm/Group Description Subjects enrolled and transplanted into the trial but not eligible for randomization. Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal. Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance. Total of all reporting groups
Overall Number of Baseline Participants 180 77 18 275
Hide Baseline Analysis Population Description
Enrolled sample (subjects transplanted in the study)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 77 participants 18 participants 275 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
161
  89.4%
68
  88.3%
13
  72.2%
242
  88.0%
>=65 years
19
  10.6%
9
  11.7%
5
  27.8%
33
  12.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 180 participants 77 participants 18 participants 275 participants
55.5  (7.83) 54.3  (9.92) 57.4  (7.70) 55.3  (8.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 77 participants 18 participants 275 participants
Female
53
  29.4%
14
  18.2%
5
  27.8%
72
  26.2%
Male
127
  70.6%
63
  81.8%
13
  72.2%
203
  73.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 77 participants 18 participants 275 participants
Hispanic or Latino
10
   5.6%
11
  14.3%
3
  16.7%
24
   8.7%
Not Hispanic or Latino
167
  92.8%
66
  85.7%
15
  83.3%
248
  90.2%
Unknown or Not Reported
3
   1.7%
0
   0.0%
0
   0.0%
3
   1.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 77 participants 18 participants 275 participants
American Indian or Alaska Native
1
   0.6%
0
   0.0%
0
   0.0%
1
   0.4%
Asian
2
   1.1%
1
   1.3%
1
   5.6%
4
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.3%
0
   0.0%
1
   0.4%
Black or African American
22
  12.2%
7
   9.1%
0
   0.0%
29
  10.5%
White
153
  85.0%
66
  85.7%
17
  94.4%
236
  85.8%
More than one race
0
   0.0%
1
   1.3%
0
   0.0%
1
   0.4%
Unknown or Not Reported
2
   1.1%
1
   1.3%
0
   0.0%
3
   1.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 180 participants 77 participants 18 participants 275 participants
180 77 18 275
Serum Creatinine   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 180 participants 77 participants 18 participants 275 participants
1.5  (1.18) 1.3  (0.65) 1.1  (0.68) 1.4  (1.04)
[1]
Measure Description: The latest creatinine value collected at the screening or baseline visit prior to transplant was used for this measure. The test measures kidney function. According to Harrison's Principles of Internal Medicine, normal results are 0.6 to 1.2 mg/dL for men and 0.5 to 0.9 mg/dL for women. Abnormal kidney function results in increased levels of serum creatinine.
1.Primary Outcome
Title Number of Participants With Clinical Complications Usually Attributed to Immunosuppression
Hide Description This is a composite endpoint comprising clinical complications related to immunosuppression and is defined as the occurrence of any of the following: death or graft loss, grade 4 secondary malignancy (graded by Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), grade 4 opportunistic infection (graded by CTCAE version 3.0), stage 3 or higher fibrosis, or decrease in renal function. Decrease in renal function is defined as: a) the estimated glomerular filtration rate (eGFR) using creatinine obtained prior to and closest to randomization will be considered the baseline and will be compared to the eGFR using creatinine obtained at 24 months +/- 3 months after randomization; b) for those with a baseline eGFR 30-90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR; c) for those with a baseline eGFR greater than 90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR and a decrease in eGFR to less than 90 ml per min per 1.73 meter-squared.
Time Frame Randomization to 2 years post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable randomized subjects having a targeted event and/or having available data for calculation of eGFR
Arm/Group Title Randomized to Immunosuppression Withdrawal Randomized to Immunosuppression Maintenance
Hide Arm/Group Description:
Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
Overall Number of Participants Analyzed 66 13
Measure Type: Number
Unit of Measure: participants
12 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized to Immunosuppression Withdrawal, Randomized to Immunosuppression Maintenance
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -13
Confidence Interval (2-Sided) 90%
-35 to 10
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Who Qualify for Random Assignment
Hide Description [Not Specified]
Time Frame One to two years post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects transplanted
Arm/Group Title All Enrolled
Hide Arm/Group Description:
Subjects who underwent liver transplantation in the trial.
Overall Number of Participants Analyzed 275
Measure Type: Number
Unit of Measure: participants
95
3.Secondary Outcome
Title Number of Participants Who Successfully Stop Taking Immunosuppression for at Least 6 Months
Hide Description [Not Specified]
Time Frame Randomization until study completion or participant termination (up to six years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to immunosuppression withdrawal
Arm/Group Title Randomized to Immunosuppression Withdrawal
Hide Arm/Group Description:
Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
Overall Number of Participants Analyzed 77
Measure Type: Number
Unit of Measure: participants
12
4.Secondary Outcome
Title Immunosuppression-free Duration
Hide Description Time (in days) from withdrawing off of all immunosuppressive drugs to re-starting immunosuppression or study termination/completion.
Time Frame Discontinuation of all immunosuppression to end of trial participation or to time of restarting immunosuppression, whichever came first, assessed up to two years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to immunosuppression withdrawal who completed withdrawal and discontinued all immunosuppression
Arm/Group Title Randomized to Immunosuppression Withdrawal
Hide Arm/Group Description:
Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
Overall Number of Participants Analyzed 14
Mean (Full Range)
Unit of Measure: Days
555.2
(36 to 790)
5.Secondary Outcome
Title Number of Hepatitis C Infected Participants With Progression of Hepatitis C Related Liver Disease, Defined as Stage 4 or Higher Fibrosis on the Ishak Scale
Hide Description Number of subjects with a biopsy showing stage 4 fibrosis or higher on the Ishak scale. Stage 4 represents at least 13.7% fibrosis measurement with a description of fibrous expansion of portal areas with marked bridging (P-P) as well as portal to central (P-C). Stage 5 is marked bridging (P-P and/or P-C), with occasional nodules (incomplete cirrhosis) and stage 6 is cirrhosis, probable or definite.
Time Frame Randomization to 2 years post-randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
Hepatitis C infected participants randomized.
Arm/Group Title Randomized to Immunosuppression Withdrawal Randomized to Immunosuppression Maintenance
Hide Arm/Group Description:
Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
Overall Number of Participants Analyzed 30 7
Measure Type: Number
Unit of Measure: participants
0 0
6.Secondary Outcome
Title Number of Participants Experiencing Graft Loss or Death
Hide Description Number of participants with graft loss or death. Graft loss is defined as subject death or re-transplantation.
Time Frame Randomization to 2 years post-randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants (intent-to-treat sample)
Arm/Group Title Randomized to Immunosuppression Withdrawal Randomized to Immunosuppression Maintenance
Hide Arm/Group Description:
Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
Overall Number of Participants Analyzed 77 18
Measure Type: Number
Unit of Measure: participants
1 0
7.Secondary Outcome
Title Total Immunosuppression From Month 21 to Month 24 Post-randomization
Hide Description Daily immunosuppression score in units per day averaged over the 3-month period from Month 21 to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.)
Time Frame Month 21 to Month 24 post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants still being followed 24 months post-randomization.
Arm/Group Title Randomized to Immunosuppression Withdrawal Randomized to Immunosuppression Maintenance
Hide Arm/Group Description:
Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
Overall Number of Participants Analyzed 64 13
Mean (Full Range)
Unit of Measure: units per day
2.8
(0.0 to 10.0)
3.7
(1.5 to 8.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized to Immunosuppression Withdrawal, Randomized to Immunosuppression Maintenance
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0183
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for immunosuppression dose the subject was receiving at the time of randomization.
8.Secondary Outcome
Title Total Burden of Immunosuppression From Random Assignment to Month 24
Hide Description Total immunosuppression score in units taken as the sum of units per day over the 2-year period from randomization to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.).
Time Frame Randomization to Month 24 post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants still being followed 24 months post-randomization.
Arm/Group Title Randomized to Immunosuppression Withdrawal Randomized to Immunosuppression Maintenance
Hide Arm/Group Description:
Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
Overall Number of Participants Analyzed 64 13
Mean (Full Range)
Unit of Measure: units
2198.5
(255 to 4604)
2708.4
(1126 to 6853)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized to Immunosuppression Withdrawal, Randomized to Immunosuppression Maintenance
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for immunosuppression dose the subject was receiving at the time of randomization.
Time Frame Enrollment through end of study (up to 7 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Terminated Prior to Randomization Randomized to Immunosuppression Withdrawal Randomized to Immunosuppression Maintenance
Hide Arm/Group Description Subjects enrolled and transplanted into the trial but not eligible for randomization. Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal. Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
All-Cause Mortality
Terminated Prior to Randomization Randomized to Immunosuppression Withdrawal Randomized to Immunosuppression Maintenance
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Terminated Prior to Randomization Randomized to Immunosuppression Withdrawal Randomized to Immunosuppression Maintenance
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   89/180 (49.44%)      9/18 (50.00%)      54/77 (70.13%)    
Blood and lymphatic system disorders       
Anaemia  1  7/180 (3.89%)  7 0/18 (0.00%)  0 2/77 (2.60%)  2
Coagulopathy  1  1/180 (0.56%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Leukocytosis  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Neutropenia  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Pancytopenia  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Thrombocytopenia  1  1/180 (0.56%)  1 0/18 (0.00%)  0 1/77 (1.30%)  1
Cardiac disorders       
Angina pectoris  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Angina unstable  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Atrial fibrillation  1  3/180 (1.67%)  3 2/18 (11.11%)  2 0/77 (0.00%)  0
Atrioventricular block complete  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Cardiac arrest  1  2/180 (1.11%)  2 0/18 (0.00%)  0 1/77 (1.30%)  1
Cardiac failure  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Cardiac failure acute  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Cardiac failure congestive  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Cardio-respiratory arrest  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Coronary artery disease  1  1/180 (0.56%)  1 0/18 (0.00%)  0 1/77 (1.30%)  1
Myocardial infarction  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Pericardial effusion  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Supraventricular extrasystoles  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Supraventricular tachycardia  1  1/180 (0.56%)  1 0/18 (0.00%)  0 2/77 (2.60%)  2
Ventricular tachycardia  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Endocrine disorders       
Hypothyroidism  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Abdominal hernia  1  0/180 (0.00%)  0 1/18 (5.56%)  1 2/77 (2.60%)  2
Abdominal pain  1  3/180 (1.67%)  3 0/18 (0.00%)  0 2/77 (2.60%)  3
Abdominal pain upper  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Ascites  1  4/180 (2.22%)  6 0/18 (0.00%)  0 1/77 (1.30%)  1
Diarrhoea  1  2/180 (1.11%)  3 0/18 (0.00%)  0 0/77 (0.00%)  0
Femoral hernia, obstructive  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Food poisoning  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Gastrointestinal haemorrhage  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Gastrooesophageal reflux disease  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Ileus  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Inguinal hernia  1  1/180 (0.56%)  1 0/18 (0.00%)  0 2/77 (2.60%)  2
Inguinal hernia, obstructive  1  1/180 (0.56%)  1 0/18 (0.00%)  0 1/77 (1.30%)  1
Intestinal strangulation  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Intra-abdominal haemorrhage  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Large intestine perforation  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Nausea  1  3/180 (1.67%)  5 0/18 (0.00%)  0 1/77 (1.30%)  1
Oesophageal varices haemorrhage  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Pancreatitis necrotising  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Peritoneal effusion  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Rectal haemorrhage  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Retroperitoneal haemorrhage  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Small intestinal obstruction  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Umbilical hernia  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Vomiting  1  3/180 (1.67%)  3 0/18 (0.00%)  0 2/77 (2.60%)  2
General disorders       
Chest pain  1  2/180 (1.11%)  2 0/18 (0.00%)  0 1/77 (1.30%)  1
Death  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Fatigue  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Hernia obstructive  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Oedema peripheral  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Pyrexia  1  5/180 (2.78%)  6 0/18 (0.00%)  0 4/77 (5.19%)  4
Hepatobiliary disorders       
Bile duct obstruction  1  0/180 (0.00%)  0 1/18 (5.56%)  1 1/77 (1.30%)  1
Bile duct stenosis  1  0/180 (0.00%)  0 2/18 (11.11%)  2 4/77 (5.19%)  4
Cholangitis  1  4/180 (2.22%)  5 2/18 (11.11%)  2 0/77 (0.00%)  0
Cholelithiasis  1  1/180 (0.56%)  2 0/18 (0.00%)  0 1/77 (1.30%)  1
Cholestasis  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Chronic hepatic failure  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Hepatic artery stenosis  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Hepatic cirrhosis  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Hepatic steatosis  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Hepatitis cholestatic  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Hepatorenal syndrome  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Immune system disorders       
Graft versus host disease  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Transplant rejection  1  26/180 (14.44%)  28 1/18 (5.56%)  1 21/77 (27.27%)  25
Infections and infestations       
Abdominal abscess  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Aspergillosis  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Bacteraemia  1  2/180 (1.11%)  2 0/18 (0.00%)  0 2/77 (2.60%)  2
Beta haemolytic streptococcal infection  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Brain abscess  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Bronchopulmonary aspergillosis  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Catheter related infection  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Cellulitis  1  0/180 (0.00%)  0 0/18 (0.00%)  0 4/77 (5.19%)  4
Clostridial infection  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Clostridium difficile colitis  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Coxsackie viral infection  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Cryptococcosis  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Cytomegalovirus colitis  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Cytomegalovirus infection  1  3/180 (1.67%)  3 0/18 (0.00%)  0 2/77 (2.60%)  2
Diverticulitis  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Empyema  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Enterococcal bacteraemia  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Escherichia bacteraemia  1  1/180 (0.56%)  1 1/18 (5.56%)  1 0/77 (0.00%)  0
Gastroenteritis  1  2/180 (1.11%)  2 1/18 (5.56%)  1 0/77 (0.00%)  0
Groin abscess  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Hepatitis C  1  7/180 (3.89%)  7 0/18 (0.00%)  0 0/77 (0.00%)  0
Herpes simplex  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Liver abscess  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Meningitis cryptococcal  1  1/180 (0.56%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Perihepatic abscess  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Peritonitis bacterial  1  1/180 (0.56%)  1 0/18 (0.00%)  0 1/77 (1.30%)  1
Pneumonia  1  1/180 (0.56%)  2 1/18 (5.56%)  1 1/77 (1.30%)  1
Pneumonia staphylococcal  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Postoperative wound infection  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Sepsis  1  8/180 (4.44%)  8 2/18 (11.11%)  2 2/77 (2.60%)  2
Streptococcal bacteraemia  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Urinary tract infection  1  3/180 (1.67%)  3 0/18 (0.00%)  0 3/77 (3.90%)  3
Viral diarrhoea  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Viral infection  1  1/180 (0.56%)  1 0/18 (0.00%)  0 1/77 (1.30%)  1
Wound infection  1  4/180 (2.22%)  4 0/18 (0.00%)  0 0/77 (0.00%)  0
Injury, poisoning and procedural complications       
Biliary anastomosis complication  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Fall  1  1/180 (0.56%)  1 0/18 (0.00%)  0 1/77 (1.30%)  1
Graft dysfunction  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Hip fracture  1  1/180 (0.56%)  2 0/18 (0.00%)  0 1/77 (1.30%)  1
Incisional hernia  1  2/180 (1.11%)  2 1/18 (5.56%)  1 6/77 (7.79%)  6
Injury  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Joint dislocation  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Medical device complication  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  2
Poisoning  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Post procedural bile leak  1  7/180 (3.89%)  7 1/18 (5.56%)  1 1/77 (1.30%)  1
Post procedural haemorrhage  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Procedural complication  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Therapeutic agent toxicity  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Vascular pseudoaneurysm  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Wound dehiscence  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Wound secretion  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Investigations       
Alanine aminotransferase increased  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Aspartate aminotransferase increased  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Blood alkaline phosphatase increased  1  1/180 (0.56%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Blood bilirubin increased  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Blood creatinine increased  1  1/180 (0.56%)  1 0/18 (0.00%)  0 2/77 (2.60%)  2
Electrocardiogram T wave inversion  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Gamma-glutamyltransferase increased  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Hepatic enzyme increased  1  4/180 (2.22%)  4 0/18 (0.00%)  0 0/77 (0.00%)  0
Liver function test abnormal  1  4/180 (2.22%)  4 0/18 (0.00%)  0 0/77 (0.00%)  0
Transaminases increased  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  5/180 (2.78%)  6 0/18 (0.00%)  0 5/77 (6.49%)  5
Diabetes mellitus  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Fluid overload  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Hyperglycaemia  1  3/180 (1.67%)  3 0/18 (0.00%)  0 0/77 (0.00%)  0
Hyperkalaemia  1  9/180 (5.00%)  11 0/18 (0.00%)  0 1/77 (1.30%)  1
Hypoglycaemia  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Hypoglycaemic seizure  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Hypomagnesaemia  1  0/180 (0.00%)  0 0/18 (0.00%)  0 2/77 (2.60%)  2
Hyponatraemia  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Obesity  1  0/180 (0.00%)  0 1/18 (5.56%)  1 1/77 (1.30%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Groin pain  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Muscular weakness  1  1/180 (0.56%)  1 0/18 (0.00%)  0 1/77 (1.30%)  1
Osteoarthritis  1  0/180 (0.00%)  0 0/18 (0.00%)  0 2/77 (2.60%)  2
Polyarthritis  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hepatic neoplasm malignant  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Hepatic neoplasm malignant recurrent  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Multiple myeloma  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Myelodysplastic syndrome  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Squamous cell carcinoma  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Nervous system disorders       
Central pontine myelinolysis  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Cerebral haemorrhage  1  3/180 (1.67%)  4 0/18 (0.00%)  0 0/77 (0.00%)  0
Cerebral infarction  1  0/180 (0.00%)  0 0/18 (0.00%)  0 2/77 (2.60%)  2
Cerebrovascular accident  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Convulsion  1  5/180 (2.78%)  5 0/18 (0.00%)  0 1/77 (1.30%)  1
Haemorrhagic stroke  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Hepatic encephalopathy  1  0/180 (0.00%)  0 0/18 (0.00%)  0 2/77 (2.60%)  2
Lacunar infarction  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Reversible posterior leukoencephalopathy syndrome  1  1/180 (0.56%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Subarachnoid haemorrhage  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Psychiatric disorders       
Confusional state  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Mental disorder due to a general medical condition  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Mental status changes  1  4/180 (2.22%)  4 0/18 (0.00%)  0 0/77 (0.00%)  0
Suicide attempt  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Renal and urinary disorders       
Anuria  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Calculus ureteric  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Haematuria  1  0/180 (0.00%)  0 1/18 (5.56%)  1 1/77 (1.30%)  1
Renal failure  1  4/180 (2.22%)  4 0/18 (0.00%)  0 0/77 (0.00%)  0
Renal failure acute  1  5/180 (2.78%)  5 0/18 (0.00%)  0 3/77 (3.90%)  5
Renal failure chronic  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Tubulointerstitial nephritis  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Dyspnoea  1  4/180 (2.22%)  4 0/18 (0.00%)  0 3/77 (3.90%)  3
Epistaxis  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Haemothorax  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Hypoxia  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Lung disorder  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Pleural effusion  1  4/180 (2.22%)  5 0/18 (0.00%)  0 0/77 (0.00%)  0
Pneumonia aspiration  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Pulmonary cavitation  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Pulmonary embolism  1  2/180 (1.11%)  2 0/18 (0.00%)  0 0/77 (0.00%)  0
Respiratory failure  1  4/180 (2.22%)  4 0/18 (0.00%)  0 0/77 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pruritus  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Rash  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Social circumstances       
Treatment noncompliance  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Surgical and medical procedures       
Gastrectomy  1  0/180 (0.00%)  0 1/18 (5.56%)  1 1/77 (1.30%)  1
Haematoma evacuation  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Inguinal hernia repair  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Medical device change  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Small intestinal resection  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Spinal fusion surgery  1  0/180 (0.00%)  0 0/18 (0.00%)  0 1/77 (1.30%)  1
Vascular disorders       
Deep vein thrombosis  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Haemorrhage  1  1/180 (0.56%)  1 0/18 (0.00%)  0 1/77 (1.30%)  1
Hypertension  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Hypotension  1  3/180 (1.67%)  3 0/18 (0.00%)  0 1/77 (1.30%)  1
Venous thrombosis  1  1/180 (0.56%)  1 0/18 (0.00%)  0 0/77 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Terminated Prior to Randomization Randomized to Immunosuppression Withdrawal Randomized to Immunosuppression Maintenance
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   155/180 (86.11%)      18/18 (100.00%)      76/77 (98.70%)    
Blood and lymphatic system disorders       
Anaemia  1  27/180 (15.00%)  37 3/18 (16.67%)  3 11/77 (14.29%)  14
Neutropenia  1  7/180 (3.89%)  7 2/18 (11.11%)  2 4/77 (5.19%)  4
Thrombocytopenia  1  0/180 (0.00%)  0 1/18 (5.56%)  1 2/77 (2.60%)  2
Cardiac disorders       
Bradycardia  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Ear and labyrinth disorders       
Ear pain  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Eye disorders       
Ocular icterus  1  6/180 (3.33%)  6 1/18 (5.56%)  1 0/77 (0.00%)  0
Visual impairment  1  2/180 (1.11%)  2 1/18 (5.56%)  1 1/77 (1.30%)  1
Gastrointestinal disorders       
Abdominal distension  1  7/180 (3.89%)  7 1/18 (5.56%)  1 3/77 (3.90%)  3
Abdominal hernia  1  2/180 (1.11%)  2 3/18 (16.67%)  3 1/77 (1.30%)  1
Abdominal pain  1  9/180 (5.00%)  11 0/18 (0.00%)  0 7/77 (9.09%)  7
Abdominal pain upper  1  3/180 (1.67%)  3 1/18 (5.56%)  1 4/77 (5.19%)  4
Ascites  1  13/180 (7.22%)  15 1/18 (5.56%)  1 2/77 (2.60%)  2
Constipation  1  6/180 (3.33%)  7 0/18 (0.00%)  0 6/77 (7.79%)  8
Diarrhoea  1  25/180 (13.89%)  28 2/18 (11.11%)  2 13/77 (16.88%)  18
Dyspepsia  1  1/180 (0.56%)  1 1/18 (5.56%)  1 1/77 (1.30%)  1
Gastrooesophageal reflux disease  1  1/180 (0.56%)  1 1/18 (5.56%)  1 4/77 (5.19%)  5
Nausea  1  11/180 (6.11%)  12 2/18 (11.11%)  2 10/77 (12.99%)  13
Umbilical hernia  1  3/180 (1.67%)  3 0/18 (0.00%)  0 4/77 (5.19%)  4
Vomiting  1  6/180 (3.33%)  6 0/18 (0.00%)  0 9/77 (11.69%)  11
General disorders       
Asthenia  1  4/180 (2.22%)  4 1/18 (5.56%)  1 2/77 (2.60%)  2
Fatigue  1  8/180 (4.44%)  9 0/18 (0.00%)  0 8/77 (10.39%)  9
Influenza like illness  1  2/180 (1.11%)  2 0/18 (0.00%)  0 5/77 (6.49%)  7
Oedema  1  12/180 (6.67%)  14 0/18 (0.00%)  0 5/77 (6.49%)  5
Oedema peripheral  1  43/180 (23.89%)  45 4/18 (22.22%)  4 16/77 (20.78%)  18
Pyrexia  1  15/180 (8.33%)  17 1/18 (5.56%)  1 13/77 (16.88%)  17
Hepatobiliary disorders       
Bile duct stenosis  1  8/180 (4.44%)  8 0/18 (0.00%)  0 6/77 (7.79%)  6
Biloma  1  2/180 (1.11%)  2 1/18 (5.56%)  1 0/77 (0.00%)  0
Cholestasis  1  1/180 (0.56%)  1 1/18 (5.56%)  1 0/77 (0.00%)  0
Immune system disorders       
Hypersensitivity  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Transplant rejection  1  18/180 (10.00%)  18 2/18 (11.11%)  2 15/77 (19.48%)  15
Infections and infestations       
Bronchitis  1  1/180 (0.56%)  1 1/18 (5.56%)  1 5/77 (6.49%)  5
Cellulitis  1  3/180 (1.67%)  3 0/18 (0.00%)  0 7/77 (9.09%)  7
Escherichia bacteraemia  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Gastroenteritis viral  1  0/180 (0.00%)  0 0/18 (0.00%)  0 4/77 (5.19%)  6
Hepatitis C  1  35/180 (19.44%)  35 2/18 (11.11%)  2 16/77 (20.78%)  16
Herpes zoster  1  1/180 (0.56%)  1 1/18 (5.56%)  1 4/77 (5.19%)  4
Nasopharyngitis  1  0/180 (0.00%)  0 1/18 (5.56%)  1 4/77 (5.19%)  5
Pneumonia  1  6/180 (3.33%)  6 0/18 (0.00%)  0 5/77 (6.49%)  5
Sinusitis  1  3/180 (1.67%)  3 0/18 (0.00%)  0 7/77 (9.09%)  8
Upper respiratory tract infection  1  3/180 (1.67%)  3 0/18 (0.00%)  0 8/77 (10.39%)  11
Urinary tract infection  1  14/180 (7.78%)  16 0/18 (0.00%)  0 10/77 (12.99%)  22
Injury, poisoning and procedural complications       
Biliary anastomosis complication  1  2/180 (1.11%)  2 0/18 (0.00%)  0 4/77 (5.19%)  4
Concussion  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Foot fracture  1  0/180 (0.00%)  0 1/18 (5.56%)  1 2/77 (2.60%)  2
Incision site complication  1  8/180 (4.44%)  8 1/18 (5.56%)  1 6/77 (7.79%)  6
Incision site pain  1  5/180 (2.78%)  5 1/18 (5.56%)  1 6/77 (7.79%)  7
Incisional hernia  1  6/180 (3.33%)  6 3/18 (16.67%)  3 2/77 (2.60%)  2
Post procedural bile leak  1  14/180 (7.78%)  15 2/18 (11.11%)  2 2/77 (2.60%)  2
Rib fracture  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Upper limb fracture  1  0/180 (0.00%)  0 1/18 (5.56%)  1 1/77 (1.30%)  1
Investigations       
Alanine aminotransferase increased  1  3/180 (1.67%)  3 1/18 (5.56%)  1 6/77 (7.79%)  10
Aspartate aminotransferase increased  1  2/180 (1.11%)  2 1/18 (5.56%)  1 5/77 (6.49%)  9
Blood alkaline phosphatase increased  1  3/180 (1.67%)  4 1/18 (5.56%)  1 6/77 (7.79%)  7
Blood bilirubin increased  1  3/180 (1.67%)  3 1/18 (5.56%)  1 3/77 (3.90%)  5
Blood creatinine increased  1  8/180 (4.44%)  8 1/18 (5.56%)  1 8/77 (10.39%)  8
Blood glucose increased  1  4/180 (2.22%)  4 1/18 (5.56%)  1 4/77 (5.19%)  4
Breath sounds abnormal  1  11/180 (6.11%)  12 3/18 (16.67%)  3 11/77 (14.29%)  12
Eosinophil count increased  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Gamma-glutamyltransferase increased  1  3/180 (1.67%)  3 1/18 (5.56%)  1 5/77 (6.49%)  7
Haematocrit decreased  1  2/180 (1.11%)  2 1/18 (5.56%)  1 0/77 (0.00%)  0
Haemoglobin decreased  1  3/180 (1.67%)  3 1/18 (5.56%)  1 1/77 (1.30%)  1
Hepatic enzyme increased  1  7/180 (3.89%)  7 0/18 (0.00%)  0 9/77 (11.69%)  9
International normalised ratio increased  1  0/180 (0.00%)  0 1/18 (5.56%)  1 3/77 (3.90%)  3
Liver function test abnormal  1  14/180 (7.78%)  14 3/18 (16.67%)  4 25/77 (32.47%)  32
Lymphocyte count decreased  1  1/180 (0.56%)  1 1/18 (5.56%)  1 0/77 (0.00%)  0
Red blood cell count decreased  1  1/180 (0.56%)  1 1/18 (5.56%)  1 0/77 (0.00%)  0
Weight increased  1  1/180 (0.56%)  1 1/18 (5.56%)  1 5/77 (6.49%)  5
Metabolism and nutrition disorders       
Dehydration  1  3/180 (1.67%)  3 1/18 (5.56%)  1 0/77 (0.00%)  0
Diabetes mellitus  1  29/180 (16.11%)  29 2/18 (11.11%)  3 20/77 (25.97%)  20
Gout  1  1/180 (0.56%)  2 1/18 (5.56%)  1 3/77 (3.90%)  4
Hyperglycaemia  1  19/180 (10.56%)  19 0/18 (0.00%)  0 15/77 (19.48%)  17
Hyperkalaemia  1  28/180 (15.56%)  35 3/18 (16.67%)  3 23/77 (29.87%)  28
Hyperphosphataemia  1  2/180 (1.11%)  3 1/18 (5.56%)  1 0/77 (0.00%)  0
Hypoglycaemia  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Hypomagnesaemia  1  14/180 (7.78%)  14 2/18 (11.11%)  2 13/77 (16.88%)  14
Metabolic syndrome  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  5/180 (2.78%)  5 1/18 (5.56%)  1 7/77 (9.09%)  7
Back pain  1  4/180 (2.22%)  4 1/18 (5.56%)  1 10/77 (12.99%)  10
Muscle spasms  1  5/180 (2.78%)  5 0/18 (0.00%)  0 4/77 (5.19%)  5
Musculoskeletal pain  1  3/180 (1.67%)  4 0/18 (0.00%)  0 4/77 (5.19%)  4
Neck pain  1  3/180 (1.67%)  3 0/18 (0.00%)  0 7/77 (9.09%)  7
Pain in extremity  1  1/180 (0.56%)  1 1/18 (5.56%)  1 1/77 (1.30%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  0/180 (0.00%)  0 0/18 (0.00%)  0 4/77 (5.19%)  4
Lung neoplasm  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Melanocytic naevus  1  0/180 (0.00%)  0 1/18 (5.56%)  1 1/77 (1.30%)  1
Nervous system disorders       
Convulsion  1  2/180 (1.11%)  2 1/18 (5.56%)  1 1/77 (1.30%)  1
Dizziness  1  4/180 (2.22%)  5 1/18 (5.56%)  1 2/77 (2.60%)  2
Encephalopathy  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Headache  1  13/180 (7.22%)  13 0/18 (0.00%)  0 11/77 (14.29%)  15
Hypoaesthesia  1  0/180 (0.00%)  0 1/18 (5.56%)  1 2/77 (2.60%)  2
Neuropathy peripheral  1  3/180 (1.67%)  3 1/18 (5.56%)  1 5/77 (6.49%)  5
Tremor  1  11/180 (6.11%)  12 2/18 (11.11%)  2 9/77 (11.69%)  13
Psychiatric disorders       
Confusional state  1  10/180 (5.56%)  10 0/18 (0.00%)  0 1/77 (1.30%)  1
Depression  1  6/180 (3.33%)  6 3/18 (16.67%)  5 5/77 (6.49%)  5
Insomnia  1  6/180 (3.33%)  6 0/18 (0.00%)  0 6/77 (7.79%)  7
Renal and urinary disorders       
Renal failure  1  27/180 (15.00%)  27 3/18 (16.67%)  3 15/77 (19.48%)  16
Renal failure acute  1  12/180 (6.67%)  13 0/18 (0.00%)  0 4/77 (5.19%)  4
Renal tubular necrosis  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Reproductive system and breast disorders       
Erectile dysfunction  1  0/180 (0.00%)  0 1/18 (5.56%)  1 1/77 (1.30%)  1
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/180 (0.56%)  1 0/18 (0.00%)  0 4/77 (5.19%)  4
Dyspnoea  1  6/180 (3.33%)  7 0/18 (0.00%)  0 6/77 (7.79%)  6
Pleural effusion  1  15/180 (8.33%)  16 1/18 (5.56%)  1 6/77 (7.79%)  6
Pneumothorax  1  2/180 (1.11%)  2 1/18 (5.56%)  1 2/77 (2.60%)  2
Productive cough  1  1/180 (0.56%)  1 0/18 (0.00%)  0 4/77 (5.19%)  4
Upper respiratory tract congestion  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Skin and subcutaneous tissue disorders       
Cold sweat  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Erythema  1  0/180 (0.00%)  0 1/18 (5.56%)  2 0/77 (0.00%)  0
Precancerous skin lesion  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Pruritus  1  7/180 (3.89%)  8 1/18 (5.56%)  1 5/77 (6.49%)  6
Rash  1  5/180 (2.78%)  5 1/18 (5.56%)  2 4/77 (5.19%)  5
Skin ulcer  1  1/180 (0.56%)  1 1/18 (5.56%)  1 1/77 (1.30%)  1
Surgical and medical procedures       
Finger amputation  1  0/180 (0.00%)  0 1/18 (5.56%)  1 0/77 (0.00%)  0
Vascular disorders       
Hypertension  1  12/180 (6.67%)  12 2/18 (11.11%)  2 9/77 (11.69%)  9
Hypotension  1  5/180 (2.78%)  5 1/18 (5.56%)  1 2/77 (2.60%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
EMail: DAITClinicalTrialsGov@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00135694     History of Changes
Other Study ID Numbers: DAIT ITN030ST
First Submitted: August 25, 2005
First Posted: August 26, 2005
Results First Submitted: October 13, 2016
Results First Posted: December 8, 2016
Last Update Posted: February 4, 2019