Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Immune Tolerance Network (ITN) | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent their bodies from rejecting the new organ. Long-term use of these drugs places transplant recipients at higher risk of serious infections and certain types of cancer. The purpose of this study is to determine whether immunosuppressive drugs can be safely withdrawn over a minimum of 9 months from children who received liver transplants at least 4 years ago.
In order to prevent the rejection of transplanted organs, transplant recipients are prescribed a strict, lifelong regimen of immunosuppressive drugs. While these drugs help prevent the body from rejecting the transplant, they carry numerous complications, including increased risk of serious infections and certain types of cancer. However, there is mounting evidence that a significant percentage of liver transplant recipients can maintain a healthy, functioning transplant without ongoing immunosuppression. This study will determine whether gradual withdrawal and eventual discontinuation of all immunosuppressive medication can be safely accomplished in children who received a liver transplant from a parent. Twenty eligible participants who were under 18 years old at the time of transplant, whose donor was a parent, and who received the transplant at least four years ago will be enrolled in the study.
Liver recipients will have an initial screening assessment consisting of a medical history, liver biopsy, and urine and blood collection. Eligible recipients will be placed on a modified medication schedule to gradually decrease their immunosuppression medication slowly over a 9- to 12-month period, during which time they will be closely monitored by study staff. Immunosuppressive drugs will not be provided by this study. For a minimum of 3 and up to a maximum of 7 years, monthly telephone consultations and quarterly study visits will occur. Visits will include physical exams and blood collection to monitor the children's health during the withdrawal phase. The exact schedule of immunosuppressant withdrawal will be determined by study physicians based on participant's health and immune function test results. Donor and nondonor parents will be asked to each provide one blood sample during the initial study visits for immunologic and genetic testing.
*** IMPORTANT NOTICE: *** The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell, organ, or tissue transplants outside of physician-directed, controlled clinical studies. Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances, upon the recommendation and with the guidance of your health care provider.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunosuppression Withdrawal | Experimental | Recipients of parental living donor liver transplants 4 or more years prior to trial enrollment, who also had stable allograft function during the preceding 6 months while taking a single immunosuppressive drug were permitted to undergo withdrawal of immunosuppression therapy. With high dose, daily dose reduction by 25% for 8 weeks. With low dose, daily dose reduction by 25% for 4 weeks. Participants are carefully evaluated/monitored throughout the study by assessments including but not limited to liver biopsy, liver tests and clinic visits, alloantibodies, autoantibodies and quantitative immunoglobulin G test results. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunosuppression Withdrawal | Drug | Gradual withdrawal of immunosuppressive medication. With high dose, daily dose reduction by 25% for 8 weeks. With low dose, daily dose reduction by 25% for 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Successfully Withdrawn From Immunosuppression | Participants were considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least one year with normal allograft function. | 1 year after completion of immunosuppression withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Suffered Graft Loss or Died Following Initiation of Immunosuppression Withdrawal | Participants who died while on the study for any reason as well as participants that experienced the loss of their transplant while a participant in the study. | Enrollment through end of study (up to 9.5 years) |
Not provided
Inclusion Criteria for Liver Recipients:
Inclusion Criteria for Liver Donors:
Exclusion Criteria for Liver Recipients:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sandy Feng, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Children's Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16433002 | Background | Reding R. Long-term complications of immunosuppression in pediatric liver recipients. Acta Gastroenterol Belg. 2005 Oct-Dec;68(4):453-6. | |
| 22253395 | Result | Feng S, Ekong UD, Lobritto SJ, Demetris AJ, Roberts JP, Rosenthal P, Alonso EM, Philogene MC, Ikle D, Poole KM, Bridges ND, Turka LA, Tchao NK. Complete immunosuppression withdrawal and subsequent allograft function among pediatric recipients of parental living donor liver transplants. JAMA. 2012 Jan 18;307(3):283-93. doi: 10.1001/jama.2011.2014. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SDY662:WISP-R ITN029ST | Individual Participant Data Set | View IPD |
Participant level data and additional study materials are available to the public in: 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from Division of Allergy, Immunology, and Transplantation (DAIT)-funded grants and contracts and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal.
Not provided
Already available to the public.
Available to the public. Study ID is SDY662:WISP-R ITN029ST
Informed consent was obtained from eligible individuals prior to screening assessments. Participants then underwent procedures at screening to determine eligibility according to the study's inclusion/exclusion criteria.
Three centers in the United States enrolled 20 pediatric recipients of parental living-donor liver allografts between June 2006 and August 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Immunosuppression Withdrawal Arm | Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Immunosuppression Withdrawal Arm | Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Successfully Withdrawn From Immunosuppression | Participants were considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least one year with normal allograft function. | Intent-to-Treat | Posted | Number | Proportion of participants | 1 year after completion of immunosuppression withdrawal |
|
Enrollment through end of study (up to 9.5 years)
Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immunosuppression Withdrawal Arm | Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsgov@niaid.nih.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 19, 2011 | Apr 20, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2010 | Apr 20, 2018 | SAP_001.pdf |
Not provided
Recipients of parental living-donor liver allografts will undergo gradual withdrawal as tolerated of immunosuppression with the goal of complete withdrawal.
Not provided
Not provided
Not provided
Not provided
|
| Time From Start of Immunosuppression Withdrawal to the First Episode of Acute Rejection, Second Episode of Rejection That Did Not Require Treatment, or to Diagnosis of Chronic Rejection |
The number of days between the start of immunosuppression (IS) withdrawal and the first episode of acute rejection (either clinical rejection or based on BANFF criteria), second episode of rejection that did not require treatment, or the first diagnosis of chronic rejection. |
| From the start of immunosuppression withdrawal to first acute rejection, second episode of rejection that did not require treatment, or diagnosis of chronic rejection through end of study (up to 9.5 years) |
| Immunosuppression-Free Duration | The number of months between the end of immunosuppression withdrawal and either the end of trial participation or the time of restarting immunosuppression | Completion of Withdrawal to either end of trial participation (up to 9.5 years) or time to restarting immunosuppression |
| Distribution of Histologic Severity Among Rejection Episodes | The number of participants within each level of histologic severity based on BANFF grading criteria (Mild, Moderate, Severe). | Start of immunosuppressive withdrawal to rejection through end of study (up to 9.5 years) |
| Number of Participants Experiencing Adverse Events by Severity | The results provide the total number of participants experiencing adverse events (AEs). Participants experiencing AEs are stratified into five severity categories: mild, moderate, severe, life-threatening, and death, based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0. | Enrollment through end of study (up to 9.5 years) |
| Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR) | Percent change from baseline at each annual visit. The bedside Schwartz equation was used to estimate GFR from serum creatinine and height in children. Baseline serum creatinine was utilized in the equation, defined as the creatinine value at the start of IS tapering. Baseline height was utilized in the equation, defined as the last height recorded prior to the start of IS tapering. Serum creatinine measurements and height measurements at the annual visits were used to calculate the annual GFR. When height value was not available, the height collected prior to the annual visit was used in the GFR calculation. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits. | Enrollment through end of study (up to 9.5 years) |
| Percent Change From Baseline in Total Cholesterol | Percent change from baseline in total serum cholesterol. Cholesterol is a waxy substance your body needs to build cells, but too much can be a problem since it can build-up in arteries. Narrowed arteries can result in heart attack or stroke. This outcome looks at the percent change from baseline (cholesterol level at the start of IS tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits. | Enrollment through end of study (up to 9.5 years) |
| Percent Change From Baseline in Blood Glucose | Glucose, a sugar, is an energy source that the body relies on to properly function. If levels are too high for a long period of time, diabetes can develop. Diabetes can result in many long-term complications such as eye, kidney, and nerve damage, stroke, and cardiovascular complications. The outcome looks at the percent change from baseline (glucose level at the start of tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits. | Enrollment through end of study (up to 9.5 years) |
| Percent Change From Baseline in Systolic Blood Pressure | Systolic blood pressure (BP) measures the pressure on the blood vessels when the heart is beats and thus is pushing blood to the rest of the body. This outcome assesses the percent change from baseline (systolic blood pressure measurement at the start of tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits. | Enrollment through end of study (up to 9.5 years) |
| Percent Change From Baseline in Diastolic Blood Pressure | Diastolic blood pressure (BP) measures the pressure in the arteries when the heart is a rest and is thus filled with blood. This outcome assesses the percent change from baseline (diastolic blood pressure measurement at the start of IS tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits. | Enrollment through end of study (up to 9.5 years) |
| Chicago |
| Illinois |
| 60614 |
| United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| 25648649 | Result | Perito ER, Mohammad S, Rosenthal P, Alonso EM, Ekong UD, Lobritto SJ, Feng S. Posttransplant metabolic syndrome in the withdrawal of immunosuppression in Pediatric Liver Transplant Recipients (WISP-R) pilot trial. Am J Transplant. 2015 Mar;15(3):779-85. doi: 10.1111/ajt.13024. Epub 2015 Feb 3. |
| 27302659 | Result | Feng S, Demetris AJ, Spain KM, Kanaparthi S, Burrell BE, Ekong UD, Alonso EM, Rosenthal P, Turka LA, Ikle D, Tchao NK. Five-year histological and serological follow-up of operationally tolerant pediatric liver transplant recipients enrolled in WISP-R. Hepatology. 2017 Feb;65(2):647-660. doi: 10.1002/hep.28681. Epub 2016 Jul 27. |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| Immune Tolerance Network website | View source |
ImmPort study identifier is Study ID is SDY662:WISP-R ITN029ST |
| SDY662:WISP-R ITN029ST | Study summary, -schematic, -detailed description, -download packages et al. | View IPD | ImmPort study identifier is Study ID is SDY662:WISP-R ITN029ST |
| WISP-R ITN029ST | Individual Participant Data Set | View IPD | TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available without charge. Creating an account for ITN TrialShare is free and allows for searching studies of interest. |
| WISP-R ITN029ST | Study protocol synopsis, -navigator, abstracts and manuscripts, datasets et al. | View IPD | TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available without charge. Creating an account for ITN TrialShare is free and allows for searching studies of interest. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline Glomerular Filtration Rate (GFR) | Glomerular filtration rate (GFR) is a measure of kidney function. The bedside Schwartz equation was used to estimate GFR from serum creatinine and height in children. Baseline serum creatinine was utilized in this equation, defined as the creatinine value at the start of immunosuppressive (IS) treatment tapering. Baseline height was utilized in the equation, defined as the last height recorded prior to the start of IS treatment tapering. Estimate of normal GFR: ≥90 mL/min per 1.73 m^2. | Median | Inter-Quartile Range | mL/min/1.73 m^2 |
|
| Baseline Total Cholesterol | Total serum cholesterol collected at the start of IS tapering. Target range for total cholesterol: 75-169 mg/dL if age ≤20; high values indicate risk of cardiovascular disease | Median | Inter-Quartile Range | mg/dL |
|
| Baseline Glucose | Glucose collected at the start of tapering. This is a measure of glucose found in the blood. Glucose, a sugar, is an energy source that the body relies on to properly function. If levels are too high for a long period of time, diabetes can develop. Diabetes can result in many long-term complications such as eye, kidney, and nerve damage, stroke, and cardiovascular complications. Target range for fasting glucose: 60-106 mg/dL. | Median | Inter-Quartile Range | mg/dL |
|
| Baseline Systolic Blood Pressure | Systolic blood pressure measured at the start of IS tapering. Systolic blood pressure measures the pressure on the blood vessels when the heart beats and thus is pushing blood to the rest of the body. For pediatric participants, normal systolic blood pressure is defined as being below the 90th percentile for the participant's age, sex, and height on at least 3 separate occasions. High blood pressure, also known as hypertension, is a risk factor for coronary artery disease, stroke, heart failure, and other complications if left unmanaged. | Median | Inter-Quartile Range | mmHg |
|
| Baseline Diastolic Blood Pressure | Diastolic blood pressure measured at the start of IS tapering. Diastolic blood pressure measures the pressure in the arteries when the heart is a rest and is thus filled with blood. For pediatric participants, normal systolic blood pressure is defined as being below the 90th percentile for the participant's age, sex, and height on at least 3 separate occasions. High blood pressure, also known as hypertension, is a risk factor for coronary artery disease, stroke, heart failure, and other complications if left unmanaged. | Median | Inter-Quartile Range | mmHg |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Participants Who Suffered Graft Loss or Died Following Initiation of Immunosuppression Withdrawal | Participants who died while on the study for any reason as well as participants that experienced the loss of their transplant while a participant in the study. | Intent-to-Treat | Posted | Count of Participants | Participants | Enrollment through end of study (up to 9.5 years) |
|
|
|
|
| Secondary | Time From Start of Immunosuppression Withdrawal to the First Episode of Acute Rejection, Second Episode of Rejection That Did Not Require Treatment, or to Diagnosis of Chronic Rejection | The number of days between the start of immunosuppression (IS) withdrawal and the first episode of acute rejection (either clinical rejection or based on BANFF criteria), second episode of rejection that did not require treatment, or the first diagnosis of chronic rejection. | Intent-to-Treat participants who experienced acute rejection or were diagnosed with chronic rejection. | Posted | Mean | 95% Confidence Interval | Days | From the start of immunosuppression withdrawal to first acute rejection, second episode of rejection that did not require treatment, or diagnosis of chronic rejection through end of study (up to 9.5 years) |
|
|
|
| Secondary | Immunosuppression-Free Duration | The number of months between the end of immunosuppression withdrawal and either the end of trial participation or the time of restarting immunosuppression | Intent-to-Treat participants who completed withdrawal | Posted | Mean | 95% Confidence Interval | Months | Completion of Withdrawal to either end of trial participation (up to 9.5 years) or time to restarting immunosuppression |
|
|
|
| Secondary | Distribution of Histologic Severity Among Rejection Episodes | The number of participants within each level of histologic severity based on BANFF grading criteria (Mild, Moderate, Severe). | Participants from the Intent-to-treat group who experienced a biopsy-proven rejection episode | Posted | Number | Biopsy Proven rejection episodes | Start of immunosuppressive withdrawal to rejection through end of study (up to 9.5 years) |
|
|
|
| Secondary | Number of Participants Experiencing Adverse Events by Severity | The results provide the total number of participants experiencing adverse events (AEs). Participants experiencing AEs are stratified into five severity categories: mild, moderate, severe, life-threatening, and death, based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0. | Intent-To-Treat | Posted | Count of Participants | Participants | Enrollment through end of study (up to 9.5 years) |
|
|
|
| Secondary | Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR) | Percent change from baseline at each annual visit. The bedside Schwartz equation was used to estimate GFR from serum creatinine and height in children. Baseline serum creatinine was utilized in the equation, defined as the creatinine value at the start of IS tapering. Baseline height was utilized in the equation, defined as the last height recorded prior to the start of IS tapering. Serum creatinine measurements and height measurements at the annual visits were used to calculate the annual GFR. When height value was not available, the height collected prior to the annual visit was used in the GFR calculation. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits. | Intent-To-Treat with GFR data at visits available for analysis | Posted | Median | Inter-Quartile Range | Percent change | Enrollment through end of study (up to 9.5 years) |
|
|
|
| Secondary | Percent Change From Baseline in Total Cholesterol | Percent change from baseline in total serum cholesterol. Cholesterol is a waxy substance your body needs to build cells, but too much can be a problem since it can build-up in arteries. Narrowed arteries can result in heart attack or stroke. This outcome looks at the percent change from baseline (cholesterol level at the start of IS tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits. | Intent-To-Treat with cholesterol data available at visit | Posted | Median | Inter-Quartile Range | Percent change | Enrollment through end of study (up to 9.5 years) |
|
|
|
| Secondary | Percent Change From Baseline in Blood Glucose | Glucose, a sugar, is an energy source that the body relies on to properly function. If levels are too high for a long period of time, diabetes can develop. Diabetes can result in many long-term complications such as eye, kidney, and nerve damage, stroke, and cardiovascular complications. The outcome looks at the percent change from baseline (glucose level at the start of tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits. | Intent-To-Treat with glucose data available at visit | Posted | Median | Inter-Quartile Range | Percent change | Enrollment through end of study (up to 9.5 years) |
|
|
|
| Secondary | Percent Change From Baseline in Systolic Blood Pressure | Systolic blood pressure (BP) measures the pressure on the blood vessels when the heart is beats and thus is pushing blood to the rest of the body. This outcome assesses the percent change from baseline (systolic blood pressure measurement at the start of tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits. | Intent-to-treat with systolic blood pressure data available at visit | Posted | Median | Inter-Quartile Range | Percent change | Enrollment through end of study (up to 9.5 years) |
|
|
|
| Secondary | Percent Change From Baseline in Diastolic Blood Pressure | Diastolic blood pressure (BP) measures the pressure in the arteries when the heart is a rest and is thus filled with blood. This outcome assesses the percent change from baseline (diastolic blood pressure measurement at the start of IS tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits. | Intent-to-treat with diastolic blood pressure data available at visit | Posted | Median | Inter-Quartile Range | Percent change | Enrollment through end of study (up to 9.5 years) |
|
|
|
| 0 |
| 20 |
| 13 |
| 20 |
| 19 |
| 20 |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Portal vein stenosis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Transplant rejection | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Enterococcal bacteraemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gastritis viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Klebsiella infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Diaphragmatic hernia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ventricular septal defect repair | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Immunisation reaction | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pertussis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Graft dysfunction | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Suture related complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Smooth muscle antibody positive | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Spleen palpable | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Vitamin D decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Growing pains | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Scrotal varicose veins | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Acanthosis nigricans | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Severe |
|
| Life Threatening |
|
| Death |
|
|
| Percent Change in GFR at M24 Visit |
|
|
| Percent Change in GFR at L12 Visit |
|
|
| Percent Change in GFR at L24 Visit |
|
|
| Percent Change in GFR at E12 Visit |
|
|
| Percent Change in GFR at E24 Visit |
|
|
| Percent Change in GFR at E36 Visit |
|
|
| Percent Change in GFR at E48 Visit |
|
|
|
| Percent Change in Cholesterol at M24 Visit |
|
|
| Percent Change in Cholesterol at L12 Visit |
|
|
| Percent Change in Cholesterol at L24 Visit |
|
|
| Percent Change in Cholesterol at E12 Visit |
|
|
| Percent Change in Cholesterol at E24 Visit |
|
|
| Percent Change in Cholesterol at E36 Visit |
|
|
| Percent Change in Cholesterol at E48 Visit |
|
|
|
| Percent Change in Glucose at M24 Visit |
|
|
| Percent Change in Glucose at L12 Visit |
|
|
| Percent Change in Glucose at L24 Visit |
|
|
| Percent Change in Glucose at E12 Visit |
|
|
| Percent Change in Glucose at E24 Visit |
|
|
| Percent Change in Glucose at E36 Visit |
|
|
| Percent Change in Glucose at E48 Visit |
|
|
|
| Percent Change in Systolic BP at M24 |
|
|
| Percent Change in Systolic BP at L12 Visit |
|
|
| Percent Change in Systolic BP at L24 Visit |
|
|
| Percent Change in Systolic BP at E12 Visit |
|
|
| Percent Change in Systolic BP at E24 Visit |
|
|
| Percent Change in Systolic BP at E36 Visit |
|
|
| Percent Change in Systolic BP at E48 Visit |
|
|
|
| Percent Change in Diastolic BP at M24 Visit |
|
|
| Percent Change in Diastolic BP at L12 Visit |
|
|
| Percent Change in Diastolic BP at L24 Visit |
|
|
| Percent Change in Diastolic BP at E12 Visit |
|
|
| Percent Change in Diastolic BP at E24 Visit |
|
|
| Percent Change in Diastolic BP at E36 Visit |
|
|
| Percent Change in Diastolic BP at E48 |
|
|