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Trial record 37 of 1164 for:    MYCOPHENOLIC ACID

A Study of Mycophenolate Mofetil (CellCept) in Lung Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01014442
Recruitment Status : Completed
First Posted : November 17, 2009
Results First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Transplantation
Intervention Drug: mycophenolate mofetil
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 33 35
Completed 26 16
Not Completed 7 19
Reason Not Completed
Adverse Event             0             8
Withdrawal by Subject             4             4
Protocol Violation             2             5
Lack of Compliance             0             1
Unspecified Reason             1             1
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 33 35 68
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 35 participants 68 participants
31.3  (7.42) 54.3  (7.93) 43.1  (13.86)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 35 participants 68 participants
Female
13
  39.4%
14
  40.0%
27
  39.7%
Male
20
  60.6%
21
  60.0%
41
  60.3%
1.Primary Outcome
Title Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4
Hide Description Cmax was expressed in milligrams per liter (mg/L).
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 24
Mean (Standard Deviation)
Unit of Measure: mg/L
MPA 7.914  (5.46450) 5.608  (2.5591)
MPAG 117.210  (58.9632) 91.207  (26.3876)
AcMPAG 1.583  (0.9697) 1.810  (0.8306)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Cmax of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2649
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 1.305
Confidence Interval (2-Sided) 95%
-0.8300 to 4.2500
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3113
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 11.405
Confidence Interval (2-Sided) 95%
-10.2000 to 42.7800
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2953
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.305
Confidence Interval (2-Sided) 95%
-0.8100 to 0.1900
Estimation Comments [Not Specified]
2.Primary Outcome
Title Cmax of MPA, MPAG and AcMPAG at Day 8
Hide Description Cmax was expressed in mg/L.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
Participants with COPD, emphysema, IPF or A1AD, 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.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: mg/L
MPA 5.124  (4.2748) 6.106  (3.3663)
MPAG 100.127  (54.0215) 100.128  (25.1228)
AcMPAG 1.007  (0.5914) 1.361  (0.9163)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Cmax of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1308
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -1.29
Confidence Interval (2-Sided) 95%
-2.9900 to 0.4100
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4886
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -10.845
Confidence Interval (2-Sided) 95%
-31.5000 to 20.7900
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2218
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.6000 to 0.1900
Estimation Comments [Not Specified]
3.Primary Outcome
Title Cmax of MPA, MPAG and AcMPAG at Day 20
Hide Description Cmax was expressed in mg/L.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: mg/L
MPA 5.284  (3.8472) 6.762  (3.7405)
MPAG 93.882  (37.6112) 124.450  (45.0613)
AcMPAG 0.624  (0.3895) 1.434  (1.0501)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Cmax of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0886
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -1.87
Confidence Interval (2-Sided) 95%
-3.7900 to 0.2800
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0220
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -30.76
Confidence Interval (2-Sided) 95%
-54.9700 to -6.3600
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-1.0200 to -0.2700
Estimation Comments [Not Specified]
4.Primary Outcome
Title Cmax of MPA, MPAG and AcMPAG at Day 90
Hide Description Cmax was expressed in mg/L.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 15 12
Mean (Standard Deviation)
Unit of Measure: mg/L
MPA 12.915  (9.2479) 7.294  (3.1817)
MPAG 104.938  (44.6135) 113.453  (48.2935)
AcMPAG 1.375  (0.6514) 1.163  (0.6856)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Cmax of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0318
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 3.945
Confidence Interval (2-Sided) 95%
0.2500 to 8.2300
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7144
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -7.59
Confidence Interval (2-Sided) 95%
-51.1900 to 30.7000
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3930
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-0.3100 to 0.8800
Estimation Comments [Not Specified]
5.Primary Outcome
Title Cmax of Free MPA at Day 4
Hide Description Cmax was expressed in micrograms per liter (mcg/L).
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 23
Mean (Standard Deviation)
Unit of Measure: mcg/L
135.275  (133.2231) 84.014  (57.8348)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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 as Hodges-Lehmann estimator.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3002
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 17.08
Confidence Interval (2-Sided) 95%
-16.5000 to 74.3200
Estimation Comments [Not Specified]
6.Primary Outcome
Title Cmax of Free MPA at Day 8
Hide Description Cmax was expressed in mcg/L.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 21
Mean (Standard Deviation)
Unit of Measure: mcg/L
59.571  (35.1104) 95.553  (62.6051)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0334
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -25.24
Confidence Interval (2-Sided) 95%
-53.2500 to -2.2900
Estimation Comments [Not Specified]
7.Primary Outcome
Title Cmax of Free MPA at Day 20
Hide Description Cmax was expressed in mcg/L.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 16 20
Mean (Standard Deviation)
Unit of Measure: mcg/L
51.822  (39.9533) 100.094  (120.8269)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1151
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -23.805
Confidence Interval (2-Sided) 95%
-52.2700 to 5.9700
Estimation Comments [Not Specified]
8.Primary Outcome
Title Cmax of Free MPA at Day 90
Hide Description Cmax was expressed in mcg/L.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 11 10
Mean (Standard Deviation)
Unit of Measure: mcg/L
87.293  (97.6509) 101.472  (93.9834)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5974
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -15.63
Confidence Interval (2-Sided) 95%
-63.8800 to 30.5600
Estimation Comments [Not Specified]
9.Primary Outcome
Title Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4
Hide Description Dose-normalized Cmax was determined (in 1 per liter [1/L]) by dividing the Cmax by the actual dose taken.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 24
Mean (Standard Deviation)
Unit of Measure: 1/L
MPA Number Analyzed 21 participants 24 participants
0.00557  (0.003907) 0.00422  (0.001924)
MPAG Number Analyzed 21 participants 24 participants
0.08286  (0.037461) 0.06749  (0.017478)
AcMPAG Number Analyzed 21 participants 24 participants
0.001122  (0.0006350) 0.001388  (0.0007160)
Free MPA Number Analyzed 19 participants 23 participants
0.0000929  (0.00008796) 0.0000625  (0.00003907)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Dose-Normalized Cmax of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5466
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0.0005
Confidence Interval (2-Sided) 95%
-0.00103 to 0.00259
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3223
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0.00728
Confidence Interval (2-Sided) 95%
-0.00707 to 0.03161
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2108
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.00026
Confidence Interval (2-Sided) 95%
-0.00070 to 0.00012
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4334
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0.0000112
Confidence Interval (2-Sided) 95%
-0.0000140 to 0.0000462
Estimation Comments [Not Specified]
10.Primary Outcome
Title Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8
Hide Description Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: 1/L
MPA Number Analyzed 20 participants 22 participants
0.00356  (0.002769) 0.00435  (0.002522)
MPAG Number Analyzed 20 participants 22 participants
0.06980  (0.033524) 0.07070  (0.017856)
AcMPA Number Analyzed 20 participants 22 participants
0.000702  (0.0003736) 0.000967  (0.0006297)
Free MPA Number Analyzed 18 participants 21 participants
0.0000409  (0.00002274) 0.0000663  (0.00004075)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Dose-Normalized Cmax of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1511
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.00081
Confidence Interval (2-Sided) 95%
-0.00216 to 0.00030
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4131
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.00695
Confidence Interval (2-Sided) 95%
-0.02050 to 0.01103
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2677
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.00017
Confidence Interval (2-Sided) 95%
-0.00046 to 0.00013
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0173
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.0000185
Confidence Interval (2-Sided) 95%
-0.0000394 to -0.0000050
Estimation Comments [Not Specified]
11.Primary Outcome
Title Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20
Hide Description Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: 1/L
MPA Number Analyzed 17 participants 21 participants
0.00395  (0.002619) 0.00456  (0.002462)
MPAG Number Analyzed 17 participants 21 participants
0.07044  (0.029284) 0.08430  (0.029430)
AcMPAG Number Analyzed 17 participants 21 participants
0.000482  (0.0003487) 0.000969  (0.0006947)
Free MP Number Analyzed 16 participants 20 participants
0.0000439  (0.00004750) 0.0000666  (0.00008052)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis
Comments Dose-Normalized Cmax of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3784
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.00063
Confidence Interval (2-Sided) 95%
-0.00230 to 0.00084
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0942
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.01602
Confidence Interval (2-Sided) 95%
-0.03229 to 0.00297
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.00037
Confidence Interval (2-Sided) 95%
-0.00062 to -0.00015
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1760
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.0000126
Confidence Interval (2-Sided) 95%
-0.0000328 to -0.0000091
Estimation Comments [Not Specified]
12.Primary Outcome
Title Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90
Hide Description Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 16 12
Mean (Standard Deviation)
Unit of Measure: 1/L
MPA Number Analyzed 15 participants 12 participants
0.01261  (0.007644) 0.00742  (0.003631)
MPAG Number Analyzed 15 participants 12 participants
0.10671  (0.037035) 0.10948  (0.030395)
AcMPAG Number Analyzed 16 participants 12 participants
0.001377  (0.0006935) 0.001134  (0.0005100)
Free MPA Number Analyzed 11 participants 10 participants
0.0000945  (0.00009640) 0.0001043  (0.00009208)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Dose-Normalized Cmax of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0509
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0.0043
Confidence Interval (2-Sided) 95%
-0.00027 to 0.00833
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8262
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.00567
Confidence Interval (2-Sided) 95%
-0.03414 to 0.02671
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4345
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0.00023
Confidence Interval (2-Sided) 95%
-0.00030 to 0.00070
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6472
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.00001
Confidence Interval (2-Sided) 95%
-0.0000586 to 0.0000364
Estimation Comments [Not Specified]
13.Primary Outcome
Title Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4
Hide Description [Not Specified]
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 24
Mean (Standard Deviation)
Unit of Measure: hour
MPA Number Analyzed 21 participants 24 participants
1.823  (1.1626) 2.892  (2.9202)
MPAG Number Analyzed 21 participants 24 participants
3.713  (2.4167) 4.891  (2.6546)
AcMPAG Number Analyzed 21 participants 24 participants
2.379  (1.2344) 3.405  (1.9162)
Free MPA Number Analyzed 19 participants 23 participants
1.472  (0.3758) 1.405  (0.4644)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Tmax of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5745
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.0333
Confidence Interval (2-Sided) 95%
-1.9500 to 0.5000
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2003
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-2.3333 to 0.0833
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0929
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-2.0833 to 0.0000
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0823
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0
Confidence Interval (2-Sided) 95%
0.0000 to 0.0667
Estimation Comments [Not Specified]
14.Primary Outcome
Title Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8
Hide Description [Not Specified]
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: hour
MPA Number Analyzed 20 participants 22 participants
2.138  (1.4976) 1.659  (0.9530)
MPAG Number Analyzed 20 participants 22 participants
3.669  (1.4773) 3.647  (1.4555)
AcMPAG Number Analyzed 20 participants 22 participants
2.802  (1.2418) 2.546  (1.1508)
Free MPA Number Analyzed 18 participants 21 participants
1.272  (0.5982) 1.446  (0.3638)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Tmax of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8106
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0.0417
Confidence Interval (2-Sided) 95%
-0.5000 to 1.7333
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0
Confidence Interval (2-Sided) 95%
-0.1667 to 0.1667
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6311
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0.0667
Confidence Interval (2-Sided) 95%
-0.3333 to 1.4667
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4330
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0
Confidence Interval (2-Sided) 95%
-0.1667 to 0.0167
Estimation Comments [Not Specified]
15.Primary Outcome
Title Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20
Hide Description [Not Specified]
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: hour
MPA Number Analyzed 17 participants 21 participants
2.293  (1.9048) 2.463  (1.8928)
MPAG Number Analyzed 17 participants 21 participants
3.762  (2.2954) 4.907  (2.8568)
AcMPAG Number Analyzed 17 participants 21 participants
2.842  (1.7915) 3.411  (1.8799)
Free MPA Number Analyzed 16 participants 20 participants
1.236  (0.6144) 1.366  (0.4692)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Tmax of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0
Confidence Interval (2-Sided) 95%
-1.1667 to 0.5833
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4947
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.0833
Confidence Interval (2-Sided) 95%
-2.0000 to 0.0833
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4425
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.1667
Confidence Interval (2-Sided) 95%
-1.9667 to 0.2000
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9720
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0
Confidence Interval (2-Sided) 95%
-0.0500 to 0.0333
Estimation Comments [Not Specified]
16.Primary Outcome
Title Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90
Hide Description [Not Specified]
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 15 12
Mean (Standard Deviation)
Unit of Measure: hour
MPA Number Analyzed 15 participants 12 participants
1.450  (0.5251) 2.143  (2.2487)
MPAG Number Analyzed 15 participants 12 participants
3.095  (1.7884) 4.420  (1.9078)
AcMPAG Number Analyzed 15 participants 12 participants
2.234  (1.0899) 3.564  (2.3686)
Free MPA Number Analyzed 11 participants 10 participants
1.490  (0.0666) 1.485  (0.5282)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Tmax of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8834
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.0333
Confidence Interval (2-Sided) 95%
-1.1667 to 0.7000
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0386
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -1.8333
Confidence Interval (2-Sided) 95%
-2.2000 to 0.0000
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0558
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.525
Confidence Interval (2-Sided) 95%
-2.6167 to 0.0000
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0082
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.2333 to -0.0667
Estimation Comments [Not Specified]
17.Primary Outcome
Title Minimum Concentration (Cmin) of MPA, MPAG and AcMPAG at Day 4
Hide Description Cmin was expressed in mg/L.
Time Frame Predose (0 hour) on Day 4 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: mg/L
MPA Number Analyzed 21 participants 25 participants
1.267  (1.0082) 1.094  (0.8473)
MPAG Number Analyzed 21 participants 25 participants
66.917  (41.3384) 47.493  (17.9747)
AcMPAG Number Analyzed 21 participants 24 participants
0.602  (0.5628) 0.733  (0.4686)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Cmin of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5224
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.2600 to 0.5000
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2088
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 11.16
Confidence Interval (2-Sided) 95%
-5.2900 to 30.2900
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1794
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.165
Confidence Interval (2-Sided) 95%
-0.4500 to 0.0800
Estimation Comments [Not Specified]
18.Primary Outcome
Title Cmin of MPA, MPAG and AcMPAG at Day 8
Hide Description Cmin was expressed in mg/L.
Time Frame Predose (0 hour) on Day 8 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 24
Mean (Standard Deviation)
Unit of Measure: mg/L
MPA Number Analyzed 20 participants 24 participants
0.750  (0.6136) 0.772  (0.3482)
MPAG Number Analyzed 20 participants 24 participants
54.566  (51.2379) 57.189  (20.8518)
AcMPAG Number Analyzed 17 participants 22 participants
0.386  (0.4870) 0.517  (0.2623)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Cmin of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4027
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.125
Confidence Interval (2-Sided) 95%
-0.3800 to 0.1900
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0875
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -16.09
Confidence Interval (2-Sided) 95%
-29.3500 to 6.3900
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0112
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.3500 to -0.0500
Estimation Comments [Not Specified]
19.Primary Outcome
Title Cmin of MPA, MPAG and AcMPAG at Day 20
Hide Description Cmin was expressed in mg/L.
Time Frame Predose (0 hour) on Day 20 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 22
Mean (Standard Deviation)
Unit of Measure: mg/L
MPA Number Analyzed 18 participants 22 participants
0.782  (0.5945) 1.234  (0.9971)
MPAG Number Analyzed 18 participants 22 participants
58.484  (29.5576) 69.023  (25.6603)
AcMPAG Number Analyzed 13 participants 22 participants
0.261  (0.1662) 0.528  (0.3977)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Cmin of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0818
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.215
Confidence Interval (2-Sided) 95%
-0.5600 to 0.0500
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0945
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -14.03
Confidence Interval (2-Sided) 95%
-26.9000 to 2.9400
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0081
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.4100 to -0.0400
Estimation Comments [Not Specified]
20.Primary Outcome
Title Cmin of MPA, MPAG and AcMPAG at Day 90
Hide Description Cmin was expressed in mg/L.
Time Frame Predose (0 hour) on Day 90 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 15 12
Mean (Standard Deviation)
Unit of Measure: mg/L
MPA Number Analyzed 15 participants 12 participants
1.103  (0.7446) 1.570  (1.0282)
MPAG Number Analyzed 15 participants 12 participants
57.957  (32.6863) 80.488  (37.2631)
AcMPAG Number Analyzed 13 participants 12 participants
0.449  (0.3552) 0.466  (0.3096)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Cmin of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3289
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-1.1400 to 0.2800
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1243
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -20.3
Confidence Interval (2-Sided) 95%
-49.3900 to 4.7100
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8704
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.2800 to 0.2300
Estimation Comments [Not Specified]
21.Primary Outcome
Title Cmin of Free MPA at Day 4
Hide Description Cmin was expressed in mcg/L.
Time Frame Predose (0 hour) on Day 4 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 23
Mean (Standard Deviation)
Unit of Measure: mcg/L
40.188  (37.9357) 23.711  (14.6991)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4043
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 5.22
Confidence Interval (2-Sided) 95%
-5.0100 to 24.4900
Estimation Comments [Not Specified]
22.Primary Outcome
Title Cmin of Free MPA at Day 8
Hide Description Cmin was expressed in mcg/L.
Time Frame Predose (0 hour) on Day 8 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF 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.
Overall Number of Participants Analyzed 19 24
Mean (Standard Deviation)
Unit of Measure: mcg/L
18.161  (16.3831) 15.669  (9.6168)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8930
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-6.0700 to 8.0100
Estimation Comments [Not Specified]
23.Primary Outcome
Title Cmin of Free MPA at Day 20
Hide Description Cmin was expressed in mcg/L.
Time Frame Predose (0 hour) on Day 20 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF 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.
Overall Number of Participants Analyzed 18 20
Mean (Standard Deviation)
Unit of Measure: mcg/L
12.193  (9.1443) 20.237  (16.2117)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0819
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -4.935
Confidence Interval (2-Sided) 95%
-14.3100 to 1.1100
Estimation Comments [Not Specified]
24.Primary Outcome
Title Cmin of Free MPA at Day 90
Hide Description Cmin was expressed in mcg/L.
Time Frame Predose (0 hour) on Day 90 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF 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.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: mcg/L
8.102  (3.3201) 18.831  (12.6155)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0414
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -8.205
Confidence Interval (2-Sided) 95%
-19.2700 to -0.0700
Estimation Comments [Not Specified]
25.Primary Outcome
Title Volume of Distribution (Vz) of MPA, MPAG and AcMPAG at Day 4
Hide Description 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.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF 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.
Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: Liter
MPA Number Analyzed 21 participants 22 participants
345.46  (182.247) 287.74  (237.295)
MPAG Number Analyzed 20 participants 22 participants
11.681  (4.7587) 12.062  (3.7316)
AcMPAG Number Analyzed 20 participants 23 participants
1065.02  (611.137) 705.38  (502.996)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Vz of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1552
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 69.7186
Confidence Interval (2-Sided) 95%
-23.4659 to 162.9545
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6057
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.7836
Confidence Interval (2-Sided) 95%
-3.2675 to 2.5529
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0188
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 299.1021
Confidence Interval (2-Sided) 95%
79.5869 to 695.1789
Estimation Comments [Not Specified]
26.Primary Outcome
Title Vz of MPA, MPAG and AcMPAG at Day 8
Hide Description 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.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF 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.
Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: Liter
MPA Number Analyzed 20 participants 21 participants
465.45  (260.837) 331.51  (150.037)
MPAG Number Analyzed 20 participants 21 participants
12.168  (5.1048) 12.740  (5.2593)
AcMPAG Number Analyzed 19 participants 20 participants
1432.88  (919.423) 1173.38  (708.767)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Vz of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0659
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 88.959
Confidence Interval (2-Sided) 95%
-5.7876 to 209.0183
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7842
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.4456
Confidence Interval (2-Sided) 95%
-3.1366 to 2.2920
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4072
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 121.3737
Confidence Interval (2-Sided) 95%
-233.6483 to 560.0069
Estimation Comments [Not Specified]
27.Primary Outcome
Title Vz of MPA, MPAG and AcMPAG at Day 20
Hide Description 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.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF 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.
Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: Liter
MPA Number Analyzed 17 participants 21 participants
476.06  (267.025) 257.57  (126.679)
MPAG Number Analyzed 16 participants 17 participants
12.798  (5.1535) 9.533  (3.1984)
AcMPAG Number Analyzed 13 participants 21 participants
3006.18  (2570.205) 1571.93  (1944.621)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Vz of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0040
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 207.9933
Confidence Interval (2-Sided) 95%
71.2442 to 355.1739
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0689
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 2.6186
Confidence Interval (2-Sided) 95%
-0.1999 to 6.7766
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0306
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 635.7812
Confidence Interval (2-Sided) 95%
49.4696 to 2793.7642
Estimation Comments [Not Specified]
28.Primary Outcome
Title Vz of MPA, MPAG and AcMPAG at Day 90
Hide Description 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.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF 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.
Overall Number of Participants Analyzed 15 12
Mean (Standard Deviation)
Unit of Measure: Liter
MPA Number Analyzed 15 participants 12 participants
139.48  (78.679) 192.53  (226.826)
MPAG Number Analyzed 12 participants 8 participants
9.254  (4.6738) 9.201  (4.4274)
AcMPAG Number Analyzed 12 participants 9 participants
811.15  (404.733) 980.49  (473.444)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments Vz of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9029
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 4.7477
Confidence Interval (2-Sided) 95%
-73.5212 to 59.8304
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9692
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0.0077
Confidence Interval (2-Sided) 95%
-3.6739 to 3.9521
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3744
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -149.7962
Confidence Interval (2-Sided) 95%
-644.4526 to 311.9735
Estimation Comments [Not Specified]
29.Primary Outcome
Title Clearance (CL) of MPA, MPAG and AcMPAG at Day 4
Hide Description 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).
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF 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.
Overall Number of Participants Analyzed 21 24
Mean (Standard Deviation)
Unit of Measure: L/hours
MPA 68.471  (32.7611) 56.709  (22.3503)
MPAG 1.6754  (0.81910) 1.7615  (0.46573)
AcMPAG 206.60  (151.301) 140.96  (110.400)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments CL of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1362
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 7.8422
Confidence Interval (2-Sided) 95%
-3.9110 to 18.4444
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4325
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.1609
Confidence Interval (2-Sided) 95%
-0.5693 to 0.2710
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0316
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 47.2686
Confidence Interval (2-Sided) 95%
4.1970 to 112.7806
Estimation Comments [Not Specified]
30.Primary Outcome
Title CL of MPA, MPAG and AcMPAG at Day 8
Hide Description CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF 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.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: L/hour
MPA 90.921  (33.7184) 81.578  (63.7936)
MPAG 2.3235  (1.55336) 1.7847  (0.75624)
AcMPAG 410.86  (448.947) 253.81  (237.283)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments CL of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0572
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estmator
Estimated Value 19.0536
Confidence Interval (2-Sided) 95%
-0.4250 to 35.3852
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3198
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0.3541
Confidence Interval (2-Sided) 95%
-0.2524 to 1.1097
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0845
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 54.0322
Confidence Interval (2-Sided) 95%
-6.7706 to 160.3469
Estimation Comments [Not Specified]
31.Primary Outcome
Title CL of MPA, MPAG and AcMPAG at Day 20
Hide Description CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
Hide Arm/Group Description:
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.
Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF 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.
Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: L/hour
MPA 83.068  (27.7321) 58.295  (19.5800)
MPAG 1.9338  (0.69979) 1.4788  (0.44488)
AcMPAG 680.68  (614.970) 232.34  (179.449)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments CL of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 25.0037
Confidence Interval (2-Sided) 95%
8.2373 to 43.5102
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0277
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0.4297
Confidence Interval (2-Sided) 95%
0.0340 to 0.9925
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 318.5455
Confidence Interval (2-Sided) 95%
154.1902 to 526.1716
Estimation Comments [Not Specified]
32.Primary Outcome
Title CL of MPA, MPAG and AcMPAG at Day 90
Hide Description CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.
Time Frame Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MMF - Cystic Fibrosis MMF - COPD, Emphysema, IPF, or A1AD
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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.
Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF 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.
Overall Number of Participants Analyzed 15 12
Mean (Standard Deviation)
Unit of Measure: L/hour
MPA Number Analyzed 15 participants 12 participants
38.091  (20.9125) 36.922  (15.2129)
MPAG Number Analyzed 15 participants 12 participants
1.5701  (0.99265) 1.2433  (0.53337)
AcMPAG Number Analyzed 14 participants 12 participants
231.28  (218.455) 223.56  (191.887)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments CL of 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9417
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value -0.579
Confidence Interval (2-Sided) 95%
-14.5052 to 11.6346
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF - Cystic Fibrosis, MMF - COPD, Emphysema, IPF, or A1AD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2941
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann estimator
Estimated Value 0.1817
Confidence Interval (2-Sided) 95%
-0.1954 to 0.6246
Estimation Comments [Not Specified]