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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012231-15 |
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This open-label, single center study will assess the pharmacokinetics, efficacy and safety of mycophenolate mofetil in lung allograft recipients. Participants will be split into 2 groups according to the original disease: Group A (cystic fibrosis) and Group B (chronic obstructive pulmonary disease [COPD], emphysema, idiopathic pulmonary fibrosis, alpha-1 antitrypsin deficiency [A1AD]). All participants will receive mycophenolate mofetil orally, 1.5 grams (g) twice daily (BID) from Day 2 to 30 post transplantation, and 1 g BID from Day 31 to 90 post transplantation. Anticipated time on study treatment is 90 days, and target sample size is 50-100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate Mofetil; Cystic Fibrosis | Experimental | Participants with cystic fibrosis will receive mycophenolate mofetil 1.5 g, orally (PO), BID from Days 2 through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation. |
|
| Mycophenolate Mofetil; Other | Experimental | Participants with COPD, emphysema, idiopathic pulmonary fibrosis, or A1AD will receive mycophenolate mofetil 1.5 g, PO, BID, from Days 2 through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mycophenolate mofetil | Drug | 1.5 g PO BID from Days 2 to 30 post-transplantation, 1 g PO BID Days 31 to 90 post-transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4 | Cmax was expressed in milligrams per liter (mg/L). | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation |
| Cmax of MPA, MPAG and AcMPAG at Day 8 | Cmax was expressed in mg/L. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
| Cmax of MPA, MPAG and AcMPAG at Day 20 | Cmax was expressed in mg/L. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
| Cmax of MPA, MPAG and AcMPAG at Day 90 | Cmax was expressed in mg/L. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
| Cmax of Free MPA at Day 4 | Cmax was expressed in micrograms per liter (mcg/L). | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
| Cmax of Free MPA at Day 8 | Cmax was expressed in mcg/L. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
| Cmax of Free MPA at Day 20 | Cmax was expressed in mcg/L. |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in 1 Second (FEV1) at Day 90 Post-Transplantation | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. | Day 90 post-transplantation |
| Percent of Predicted FEV1 at Day 90 Post-Transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiothoracic, Transplantation and Vascular Surgery at Hannover Medical School | Hanover | 30625 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | MMF - Cystic Fibrosis | Participants with cystic fibrosis having transplantation at Day 0, received mycophenolate mofetil (MMF) capsules at dose of 1.5 grams (g) twice daily (BID) from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation. |
| FG001 | MMF - COPD, Emphysema, IPF, or A1AD | Participants with chronic obstructive pulmonary disorder (COPD), emphysema, idiopathic pulmonary fibrosis (IPF), or alpha-1 antitrypsin deficiency (A1AD) having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The safety population included all participants who received at least one dose of study drug and a safety follow-up, whether withdrawn prematurely or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | MMF - Cystic Fibrosis | Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation. |
| BG001 | MMF - COPD, Emphysema, IPF, or A1AD |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4 | Cmax was expressed in milligrams per liter (mg/L). | Per Protocol (PP) Population: Intent-to treat (ITT) population (received at least one dose of study drug and where the primary variable was measured at least once under study drug) excluding participants with major protocol violations (total 46 participants). Number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation |
|
From baseline up to Day 90
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MMF - Cystic Fibrosis | Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
| Cmax of Free MPA at Day 90 | Cmax was expressed in mcg/L. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
| Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4 | Dose-normalized Cmax was determined (in 1 per liter [1/L]) by dividing the Cmax by the actual dose taken. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
| Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8 | Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
| Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20 | Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
| Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90 | Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
| Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4 | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
| Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8 | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
| Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20 | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
| Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90 | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
| Minimum Concentration (Cmin) of MPA, MPAG and AcMPAG at Day 4 | Cmin was expressed in mg/L. | Predose (0 hour) on Day 4 post-transplantation |
| Cmin of MPA, MPAG and AcMPAG at Day 8 | Cmin was expressed in mg/L. | Predose (0 hour) on Day 8 post-transplantation |
| Cmin of MPA, MPAG and AcMPAG at Day 20 | Cmin was expressed in mg/L. | Predose (0 hour) on Day 20 post-transplantation |
| Cmin of MPA, MPAG and AcMPAG at Day 90 | Cmin was expressed in mg/L. | Predose (0 hour) on Day 90 post-transplantation |
| Cmin of Free MPA at Day 4 | Cmin was expressed in mcg/L. | Predose (0 hour) on Day 4 post-transplantation |
| Cmin of Free MPA at Day 8 | Cmin was expressed in mcg/L. | Predose (0 hour) on Day 8 post-transplantation |
| Cmin of Free MPA at Day 20 | Cmin was expressed in mcg/L. | Predose (0 hour) on Day 20 post-transplantation |
| Cmin of Free MPA at Day 90 | Cmin was expressed in mcg/L. | Predose (0 hour) on Day 90 post-transplantation |
| Volume of Distribution (Vz) of MPA, MPAG and AcMPAG at Day 4 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
| Vz of MPA, MPAG and AcMPAG at Day 8 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
| Vz of MPA, MPAG and AcMPAG at Day 20 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
| Vz of MPA, MPAG and AcMPAG at Day 90 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
| Clearance (CL) of MPA, MPAG and AcMPAG at Day 4 | CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in liters per hour (L/hour). | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
| CL of MPA, MPAG and AcMPAG at Day 8 | CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
| CL of MPA, MPAG and AcMPAG at Day 20 | CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
| CL of MPA, MPAG and AcMPAG at Day 90 | CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
| Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of MPA, MPAG and AcMPAG at Day 4 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours time milligrams per liter (hours*[mg/L]). | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
| AUC0-12 of MPA, MPAG and AcMPAG at Day 8 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L). | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
| AUC0-12 of MPA, MPAG and AcMPAG at Day 20 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L). | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
| AUC0-12 of MPA, MPAG and AcMPAG at Day 90 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L). | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
| AUC0-12 of Free MPA at Day 4 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours times micrograms per liter (hours*[mcg/L]). | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
| AUC0-12 of Free MPA at Day 8 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L). | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
| AUC0-12 of Free MPA at Day 20 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L). | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
| AUC0-12 of Free MPA at Day 90 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L). | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
| Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 4 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
| Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 8 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
| Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 20 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
| Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 90 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
| Free Fraction of Free MPA at Day 4 | MPA Free fraction (in percent [%]) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
| Free Fraction of Free MPA at Day 8 | MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
| Free Fraction of Free MPA at Day 20 | MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
| Free Fraction of Free MPA at Day 90 | MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%. | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Percent predicted FEV1 [%] = (FEV1 [L] / Predicted normal value FEV1 [L]) * 100% |
| Day 90 post-transplantation |
| Forced Vital Capacity (FVC) at Day 90 Post-Transplantation | FVC at Day 90 post-transplantation is reported. | Day 90 post-transplantation |
| Change From Baseline in Intracellular Adenosine-Tri-Phosphate (iATP) Levels | iATP was expressed in ng/mL. | Baseline, Days 4, 8, 20 and 90 post-transplantation |
| Change From Baseline in T-Cell Phenotype | Reported values are change in the T-cell phenotype status from baseline to Day 20 and 90 for cluster of differentiation (CD) 3, CD19, CD4, CD4CD25, CD28, CD45RA, CD45RO, CD69, CD127, and CD152. | Baseline, Days 20 and 90 post-transplantation |
| Percentage of Participants With Opportunistic Infections | Opportunistic infections included all infections which occurred due to aspergillus, candida, pneumocystis, cryptococcus, listeria, herpes zoster, herpes simplex, cytomegalovirus pathogens. | Up to Day 90 |
| Protocol Violation |
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| Lack of Compliance |
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| Unspecified Reason |
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Participants with COPD, emphysema, IPF or A1AD having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Gender | Count of Participants | Participants |
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| OG001 | MMF - COPD, Emphysema, IPF, or A1AD | Participants with COPD, emphysema, IPF or A1AD having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation. |
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| Primary | Cmax of MPA, MPAG and AcMPAG at Day 8 | Cmax was expressed in mg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
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| Primary | Cmax of MPA, MPAG and AcMPAG at Day 20 | Cmax was expressed in mg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
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| Primary | Cmax of MPA, MPAG and AcMPAG at Day 90 | Cmax was expressed in mg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
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| Primary | Cmax of Free MPA at Day 4 | Cmax was expressed in micrograms per liter (mcg/L). | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
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| Primary | Cmax of Free MPA at Day 8 | Cmax was expressed in mcg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
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| Primary | Cmax of Free MPA at Day 20 | Cmax was expressed in mcg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
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| Primary | Cmax of Free MPA at Day 90 | Cmax was expressed in mcg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
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| Primary | Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4 | Dose-normalized Cmax was determined (in 1 per liter [1/L]) by dividing the Cmax by the actual dose taken. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | 1/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
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| Primary | Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8 | Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | 1/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
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| Primary | Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20 | Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | 1/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
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| Primary | Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90 | Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | 1/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
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| Primary | Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4 | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | hour | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
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| Primary | Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8 | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | hour | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
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| Primary | Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20 | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | hour | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
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| Primary | Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90 | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | hour | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
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| Primary | Minimum Concentration (Cmin) of MPA, MPAG and AcMPAG at Day 4 | Cmin was expressed in mg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | mg/L | Predose (0 hour) on Day 4 post-transplantation |
|
|
|
|
| Primary | Cmin of MPA, MPAG and AcMPAG at Day 8 | Cmin was expressed in mg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | mg/L | Predose (0 hour) on Day 8 post-transplantation |
|
|
|
|
| Primary | Cmin of MPA, MPAG and AcMPAG at Day 20 | Cmin was expressed in mg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | mg/L | Predose (0 hour) on Day 20 post-transplantation |
|
|
|
|
| Primary | Cmin of MPA, MPAG and AcMPAG at Day 90 | Cmin was expressed in mg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | mg/L | Predose (0 hour) on Day 90 post-transplantation |
|
|
|
|
| Primary | Cmin of Free MPA at Day 4 | Cmin was expressed in mcg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/L | Predose (0 hour) on Day 4 post-transplantation |
|
|
|
|
| Primary | Cmin of Free MPA at Day 8 | Cmin was expressed in mcg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/L | Predose (0 hour) on Day 8 post-transplantation |
|
|
|
|
| Primary | Cmin of Free MPA at Day 20 | Cmin was expressed in mcg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/L | Predose (0 hour) on Day 20 post-transplantation |
|
|
|
|
| Primary | Cmin of Free MPA at Day 90 | Cmin was expressed in mcg/L. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/L | Predose (0 hour) on Day 90 post-transplantation |
|
|
|
|
| Primary | Volume of Distribution (Vz) of MPA, MPAG and AcMPAG at Day 4 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | Liter | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
|
|
|
|
| Primary | Vz of MPA, MPAG and AcMPAG at Day 8 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | Liter | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
|
|
|
|
| Primary | Vz of MPA, MPAG and AcMPAG at Day 20 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | Liter | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
|
|
|
|
| Primary | Vz of MPA, MPAG and AcMPAG at Day 90 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | Liter | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
|
|
|
|
| Primary | Clearance (CL) of MPA, MPAG and AcMPAG at Day 4 | CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in liters per hour (L/hour). | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | L/hours | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
|
|
|
|
| Primary | CL of MPA, MPAG and AcMPAG at Day 8 | CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | L/hour | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
|
|
|
|
| Primary | CL of MPA, MPAG and AcMPAG at Day 20 | CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | L/hour | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
|
|
|
|
| Primary | CL of MPA, MPAG and AcMPAG at Day 90 | CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | L/hour | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
|
|
|
|
| Primary | Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of MPA, MPAG and AcMPAG at Day 4 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours time milligrams per liter (hours*[mg/L]). | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours*(mg/L) | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
|
|
|
|
| Primary | AUC0-12 of MPA, MPAG and AcMPAG at Day 8 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L). | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours*(mg/L) | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
|
|
|
|
| Primary | AUC0-12 of MPA, MPAG and AcMPAG at Day 20 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L). | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours*(mg/L) | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
|
|
|
|
| Primary | AUC0-12 of MPA, MPAG and AcMPAG at Day 90 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L). | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | hours*(mg/L) | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
|
|
|
|
| Primary | AUC0-12 of Free MPA at Day 4 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours times micrograms per liter (hours*[mcg/L]). | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours*mcg/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
|
|
|
|
| Primary | AUC0-12 of Free MPA at Day 8 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L). | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours*mcg/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
|
|
|
|
| Primary | AUC0-12 of Free MPA at Day 20 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L). | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours*mcg/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
|
|
|
|
| Primary | AUC0-12 of Free MPA at Day 90 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L). | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours*mcg/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
|
|
|
|
| Primary | Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 4 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | hours/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
|
|
|
|
| Primary | Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 8 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | hours/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
|
|
|
|
| Primary | Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 20 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | hours/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
|
|
|
|
| Primary | Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 90 | AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category. | Posted | Mean | Standard Deviation | hours/L | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
|
|
|
|
| Primary | Free Fraction of Free MPA at Day 4 | MPA Free fraction (in percent [%]) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of free fraction | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation |
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|
|
|
| Primary | Free Fraction of Free MPA at Day 8 | MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of free fraction | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation |
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|
|
| Primary | Free Fraction of Free MPA at Day 20 | MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of free fraction | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation |
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|
| Primary | Free Fraction of Free MPA at Day 90 | MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%. | PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of free fraction | Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation |
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| Secondary | Forced Expiratory Volume in 1 Second (FEV1) at Day 90 Post-Transplantation | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. | ITT Population (total 64 participants). Here, Number of participants analyzed = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | L | Day 90 post-transplantation |
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|
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| Secondary | Percent of Predicted FEV1 at Day 90 Post-Transplantation | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Percent predicted FEV1 [%] = (FEV1 [L] / Predicted normal value FEV1 [L]) * 100% | ITT Population. Here, Number of participants analyzed = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of predicted FEV1 | Day 90 post-transplantation |
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|
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| Secondary | Forced Vital Capacity (FVC) at Day 90 Post-Transplantation | FVC at Day 90 post-transplantation is reported. | ITT Population. Here, Number of participants analyzed = participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | L | Day 90 post-transplantation |
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|
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| Secondary | Change From Baseline in Intracellular Adenosine-Tri-Phosphate (iATP) Levels | iATP was expressed in ng/mL. | ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category, for respective arm groups. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Days 4, 8, 20 and 90 post-transplantation |
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|
|
| Secondary | Change From Baseline in T-Cell Phenotype | Reported values are change in the T-cell phenotype status from baseline to Day 20 and 90 for cluster of differentiation (CD) 3, CD19, CD4, CD4CD25, CD28, CD45RA, CD45RO, CD69, CD127, and CD152. | ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category, for respective arm groups. | Posted | Mean | Standard Deviation | percentage of lymphocytes | Baseline, Days 20 and 90 post-transplantation |
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| Secondary | Percentage of Participants With Opportunistic Infections | Opportunistic infections included all infections which occurred due to aspergillus, candida, pneumocystis, cryptococcus, listeria, herpes zoster, herpes simplex, cytomegalovirus pathogens. | Safety Population | Posted | Number | percentage of participants | Up to Day 90 |
|
|
|
|
| 13 |
| 33 |
| 27 |
| 33 |
| EG001 | MMF - COPD, Emphysema, IPF, or A1AD | Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90. | 14 | 35 | 29 | 35 |
| Atrial tachycardia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Distal intestinal obstruction syndrome | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Volvulus | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cholangitis sclerosing | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Graft dysfunction | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Antibiotic resistant Staphylococcus test positive | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hydropneumorthorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hyperchromic anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Enterococcal infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Gastroenteritis norovirus | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Anastomotic complication | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Antibody test positive | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Klebsiella test positive | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bronchial polyp | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Fibrinous bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
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.
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| AcMPAG |
|
Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.4886 |
| Hodges-Lehmann estimator |
| -10.845 |
| 2-Sided |
| 95 |
| -31.5000 |
| 20.7900 |
| No |
| Superiority or Other |
| Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.2218 | Hodges-Lehmann estimator | -0.2 | 2-Sided | 95 | -0.6000 | 0.1900 | No | Superiority or Other |
| AcMPAG |
|
Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.0220 |
| Hodges-Lehmann estimator |
| -30.76 |
| 2-Sided |
| 95 |
| -54.9700 |
| -6.3600 |
| No |
| Superiority or Other |
| Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0008 | Hodges-Lehmann estimator | -0.56 | 2-Sided | 95 | -1.0200 | -0.2700 | No | Superiority or Other |
| AcMPAG |
|
Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.7144 |
| Hodges-Lehmann estimator |
| -7.59 |
| 2-Sided |
| 95 |
| -51.1900 |
| 30.7000 |
| No |
| Superiority or Other |
| Cmax of AcMPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.3930 | Hodges-Lehmann estimator | 0.27 | 2-Sided | 95 | -0.3100 | 0.8800 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
| Free MPA |
|
|
Dose-Normalized Cmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.3223 |
| Hodges-Lehmann estimator |
| 0.00728 |
| 2-Sided |
| 95 |
| -0.00707 |
| 0.03161 |
| No |
| Superiority or Other |
| Dose-Normalized Cmax of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.2108 | Hodges-Lehmann estimator | -0.00026 | 2-Sided | 95 | -0.00070 | 0.00012 | No | Superiority or Other |
| Dose-Normalized Cmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called a Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.4334 | Hodges-Lehmann estimator | 0.0000112 | 2-Sided | 95 | -0.0000140 | 0.0000462 | No | Superiority or Other |
| MPAG |
|
|
| AcMPA |
|
|
| Free MPA |
|
|
Dose-Normalized Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.4131 |
| Hodges-Lehmann estimator |
| -0.00695 |
| 2-Sided |
| 95 |
| -0.02050 |
| 0.01103 |
| No |
| Superiority or Other |
| Dose-Normalized Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.2677 | Hodges-Lehmann estimator | -0.00017 | 2-Sided | 95 | -0.00046 | 0.00013 | No | Superiority or Other |
| Dose-Normalized Cmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0173 | Hodges-Lehmann estimator | -0.0000185 | 2-Sided | 95 | -0.0000394 | -0.0000050 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
| Free MP |
|
|
Dose-Normalized Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.0942 |
| Hodges-Lehmann estimator |
| -0.01602 |
| 2-Sided |
| 95 |
| -0.03229 |
| 0.00297 |
| No |
| Superiority or Other |
| Dose-Normalized Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0032 | Hodges-Lehmann estimator | -0.00037 | 2-Sided | 95 | -0.00062 | -0.00015 | No | Superiority or Other |
| Dose-Normalized Cmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.1760 | Hodges-Lehmann estimator | -0.0000126 | 2-Sided | 95 | -0.0000328 | -0.0000091 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
| Free MPA |
|
|
Dose-Normalized Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.8262 |
| Hodges-Lehmann estimator |
| -0.00567 |
| 2-Sided |
| 95 |
| -0.03414 |
| 0.02671 |
| No |
| Superiority or Other |
| Dose-Normalized Cmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.4345 | Hodges-Lehmann estimator | 0.00023 | 2-Sided | 95 | -0.00030 | 0.00070 | No | Superiority or Other |
| Dose-Normalized Cmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.6472 | Hodges-Lehmann estimator | -0.00001 | 2-Sided | 95 | -0.0000586 | 0.0000364 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
| Free MPA |
|
|
Tmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.2003 |
| Hodges-Lehmann estimator |
| -1.8 |
| 2-Sided |
| 95 |
| -2.3333 |
| 0.0833 |
| No |
| Superiority or Other |
| Tmax of AcMPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0929 | Hodges-Lehmann estimator | -0.5 | 2-Sided | 95 | -2.0833 | 0.0000 | No | Superiority or Other |
| Tmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0823 | Hodges-Lehmann estimator | 0 | 2-Sided | 95 | 0.0000 | 0.0667 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
| Free MPA |
|
|
Tmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 1.0000 |
| Hodges-Lehmann estimator |
| 0 |
| 2-Sided |
| 95 |
| -0.1667 |
| 0.1667 |
| No |
| Superiority or Other |
| Tmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.6311 | Hodges-Lehmann estimator | 0.0667 | 2-Sided | 95 | -0.3333 | 1.4667 | No | Superiority or Other |
| Tmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.4330 | Hodges-Lehmann estimator | 0 | 2-Sided | 95 | -0.1667 | 0.0167 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
| Free MPA |
|
|
Tmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.4947 |
| Hodges-Lehmann estimator |
| -0.0833 |
| 2-Sided |
| 95 |
| -2.0000 |
| 0.0833 |
| No |
| Superiority or Other |
| Tmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.4425 | Hodges-Lehmann estimator | -0.1667 | 2-Sided | 95 | -1.9667 | 0.2000 | No | Superiority or Other |
| Tmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.9720 | Hodges-Lehmann estimator | 0 | 2-Sided | 95 | -0.0500 | 0.0333 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
| Free MPA |
|
|
Tmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.0386 |
| Hodges-Lehmann estimator |
| -1.8333 |
| 2-Sided |
| 95 |
| -2.2000 |
| 0.0000 |
| No |
| Superiority or Other |
| Tmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0558 | Hodges-Lehmann estimator | -0.525 | 2-Sided | 95 | -2.6167 | 0.0000 | No | Superiority or Other |
| Tmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0082 | Hodges-Lehmann estimator | -0.15 | 2-Sided | 95 | -0.2333 | -0.0667 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
Cmin of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.2088 |
| Hodges-Lehmann estimator |
| 11.16 |
| 2-Sided |
| 95 |
| -5.2900 |
| 30.2900 |
| No |
| Superiority or Other |
| Cmin of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.1794 | Hodges-Lehmann estimator | -0.165 | 2-Sided | 95 | -0.4500 | 0.0800 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
Cmin of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.0875 |
| Hodges-Lehmann estimator |
| -16.09 |
| 2-Sided |
| 95 |
| -29.3500 |
| 6.3900 |
| No |
| Superiority or Other |
| Cmin of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0112 | Hodges-Lehmann estimator | -0.2 | 2-Sided | 95 | -0.3500 | -0.0500 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
Cmin of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.0945 |
| Hodges-Lehmann estimator |
| -14.03 |
| 2-Sided |
| 95 |
| -26.9000 |
| 2.9400 |
| No |
| Superiority or Other |
| Cmin of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0081 | Hodges-Lehmann estimator | -0.19 | 2-Sided | 95 | -0.4100 | -0.0400 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
Cmin of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.1243 |
| Hodges-Lehmann estimator |
| -20.3 |
| 2-Sided |
| 95 |
| -49.3900 |
| 4.7100 |
| No |
| Superiority or Other |
| Cmin of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.8704 | Hodges-Lehmann estimator | -0.03 | 2-Sided | 95 | -0.2800 | 0.2300 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
Vz of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.6057 |
| Hodges-Lehmann estimator |
| -0.7836 |
| 2-Sided |
| 95 |
| -3.2675 |
| 2.5529 |
| No |
| Superiority or Other |
| Vz of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0188 | Hodges-Lehmann estimator | 299.1021 | 2-Sided | 95 | 79.5869 | 695.1789 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
Vz of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.7842 |
| Hodges-Lehmann estimator |
| -0.4456 |
| 2-Sided |
| 95 |
| -3.1366 |
| 2.2920 |
| No |
| Superiority or Other |
| Vz of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.4072 | Hodges-Lehmann estimator | 121.3737 | 2-Sided | 95 | -233.6483 | 560.0069 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
Vz of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.0689 |
| Hodges-Lehmann estimator |
| 2.6186 |
| 2-Sided |
| 95 |
| -0.1999 |
| 6.7766 |
| No |
| Superiority or Other |
| Vz of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0306 | Hodges-Lehmann estimator | 635.7812 | 2-Sided | 95 | 49.4696 | 2793.7642 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
Vz of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.9692 |
| Hodges-Lehmann estimator |
| 0.0077 |
| 2-Sided |
| 95 |
| -3.6739 |
| 3.9521 |
| No |
| Superiority or Other |
| Vz of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.3744 | Hodges-Lehmann estimator | -149.7962 | 2-Sided | 95 | -644.4526 | 311.9735 | No | Superiority or Other |
| AcMPAG |
|
CL of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.4325 |
| Hodges-Lehmann estimator |
| -0.1609 |
| 2-Sided |
| 95 |
| -0.5693 |
| 0.2710 |
| No |
| Superiority or Other |
| CL of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0316 | Hodges-Lehmann estimator | 47.2686 | 2-Sided | 95 | 4.1970 | 112.7806 | No | Superiority or Other |
| AcMPAG |
|
CL of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.3198 |
| Hodges-Lehmann estimator |
| 0.3541 |
| 2-Sided |
| 95 |
| -0.2524 |
| 1.1097 |
| No |
| Superiority or Other |
| CL of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0845 | Hodges-Lehmann estimator | 54.0322 | 2-Sided | 95 | -6.7706 | 160.3469 | No | Superiority or Other |
| AcMPAG |
|
CL of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.0277 |
| Hodges-Lehmann estimator |
| 0.4297 |
| 2-Sided |
| 95 |
| 0.0340 |
| 0.9925 |
| No |
| Superiority or Other |
| CL of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0002 | Hodges-Lehmann estimator | 318.5455 | 2-Sided | 95 | 154.1902 | 526.1716 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
CL of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.2941 |
| Hodges-Lehmann estimator |
| 0.1817 |
| 2-Sided |
| 95 |
| -0.1954 |
| 0.6246 |
| No |
| Superiority or Other |
| CL of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.8170 | Hodges-Lehmann estimator | -4.9076 | 2-Sided | 95 | -84.8234 | 109.9321 | No | Superiority or Other |
| AcMPAG |
|
AUC0-12 of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.4063 |
| Hodges-Lehmann estimator |
| 72.7203 |
| 2-Sided |
| 95 |
| -107.1596 |
| 393.5295 |
| No |
| Superiority or Other |
| AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0441 | Hodges-Lehmann estimator | -3.6042 | 2-Sided | 95 | -8.1854 | -0.1887 | No | Superiority or Other |
| AcMPAG |
|
AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.2733 |
| Hodges-Lehmann estimator |
| -171.159 |
| 2-Sided |
| 95 |
| -361.4437 |
| 171.9652 |
| No |
| Superiority or Other |
| AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0718 | Hodges-Lehmann estimator | -1.9621 | 2-Sided | 95 | -4.8456 | 0.2067 | No | Superiority or Other |
| AcMPAG |
|
AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.0058 |
| Hodges-Lehmann estimator |
| -268.9537 |
| 2-Sided |
| 95 |
| -506.7782 |
| -77.3970 |
| No |
| Superiority or Other |
| AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | <0.0001 | Hodges-Lehmann estimator | -4.828 | 2-Sided | 95 | -7.1455 | -2.6133 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.3413 |
| Hodges-Lehmann estimator |
| -156.3255 |
| 2-Sided |
| 95 |
| -526.0765 |
| 195.8348 |
| No |
| Superiority or Other |
| AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.6251 | Hodges-Lehmann estimator | 0.888 | 2-Sided | 95 | -3.0288 | 4.2273 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
| Free MPA |
|
|
Dose-Normalized AUC0-12 MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.4325 |
| Hodges-Lehmann estimator |
| 0.04797 |
| 2-Sided |
| 95 |
| -0.08467 |
| 0.26322 |
| No |
| Superiority or Other |
| Dose-Normalized AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0316 | Hodges-Lehmann estimator | -0.00311 | 2-Sided | 95 | -0.00645 | -0.00029 | No | Superiority or Other |
| Dose-Normalized AUC0-12 of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.3269 | Hodges-Lehmann estimator | 0.0000158 | 2-Sided | 95 | -0.0000134 | 0.0000552 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
| Free MPA |
|
|
Dose-Normalized AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.3198 |
| Hodges-Lehmann estimator |
| -0.09626 |
| 2-Sided |
| 95 |
| -0.25269 |
| 0.11464 |
| No |
| Superiority or Other |
| Dose-Normalized AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0845 | Hodges-Lehmann estimator | -0.00131 | 2-Sided | 95 | -0.00352 | 0.00013 | No | Superiority or Other |
| Dose-Normalized AUC0-12 of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.1769 | Hodges-Lehmann estimator | -0.00001 | 2-Sided | 95 | -0.0000250 | 0.0000043 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
| Free MPA |
|
|
Dose-Normalized AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.0277 |
| Hodges-Lehmann estimator |
| -0.14764 |
| 2-Sided |
| 95 |
| -0.31026 |
| -0.01067 |
| No |
| Superiority or Other |
| Dose-Normalized AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.0002 | Hodges-Lehmann estimator | -0.0035 | 2-Sided | 95 | -0.00476 | 0.00168 | No | Superiority or Other |
| Dose-Normalized AUC0-12 of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.1661 | Hodges-Lehmann estimator | -0.0000138 | 2-Sided | 95 | -0.0000295 | 0.0000047 | No | Superiority or Other |
| MPAG |
|
|
| AcMPAG |
|
|
| Free MPA |
|
|
Dose-Normalized AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. |
| Wilcoxon rank sum test |
| 0.2941 |
| Hodges-Lehmann estimator |
| -0.1461 |
| 2-Sided |
| 95 |
| -0.39951 |
| 0.12988 |
| No |
| Superiority or Other |
| Dose-Normalized AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.8170 | Hodges-Lehmann estimator | 0.00033 | 2-Sided | 95 | -0.00361 | 0.00421 | No | Superiority or Other |
| Dose-Normalized AUC0-12 of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator. | Wilcoxon rank sum test | 0.1927 | Hodge-Lehmann estimator | -0.0000239 | 2-Sided | 95 | -0.0000594 | 0.0000154 | No | Superiority or Other |
| Day 8 |
|
|
| Day 20 |
|
|
| Day 90 |
|
|
| CD3: Change at Day 90 |
|
|
| CD19: Change at Day 20 |
|
|
| CD19: Change at Day 90 |
|
|
| CD4: Change at Day 20 |
|
|
| CD4: Change at Day 90 |
|
|
| CD4CD25: Change at Day 20 |
|
|
| CD4CD25: Change at Day 90 |
|
|
| CD28: Change at Day 20 |
|
|
| CD28: Change at Day 90 |
|
|
| CD45RA: Change at Day 20 |
|
|
| CD45RA: Change at Day 90 |
|
|
| CD45RO: Change at Day 20 |
|
|
| CD45RO: Change at Day 90 |
|
|
| CD69: Change at Day 20 |
|
|
| CD69: Change at Day 90 |
|
|
| CD127: Change at Day 20 |
|
|
| CD127: Change at Day 90 |
|
|
| CD152: Change at Day 20 |
|
|
| CD152: Change at Day 90 |
|
|