Trial Outcomes & Findings for A Study of Mycophenolate Mofetil (CellCept) in Lung Transplant Recipients (NCT NCT01014442)

Results Overview

Cmax was expressed in milligrams per liter (mg/L).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

68 participants

Primary outcome timeframe

Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation

Results posted on

2017-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	MMF - Cystic Fibrosis Participants with cystic fibrosis having transplantation at Day 0, received mycophenolate mofetil (MMF) capsules at dose of 1.5 grams (g) twice daily (BID) from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.	MMF - COPD, Emphysema, IPF, or A1AD Participants with chronic obstructive pulmonary disorder (COPD), emphysema, idiopathic pulmonary fibrosis (IPF), or alpha-1 antitrypsin deficiency (A1AD) having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
Overall Study STARTED	33	35
Overall Study COMPLETED	26	16
Overall Study NOT COMPLETED	7	19

Reasons for withdrawal

Reasons for withdrawal
Measure	MMF - Cystic Fibrosis Participants with cystic fibrosis having transplantation at Day 0, received mycophenolate mofetil (MMF) capsules at dose of 1.5 grams (g) twice daily (BID) from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.	MMF - COPD, Emphysema, IPF, or A1AD Participants with chronic obstructive pulmonary disorder (COPD), emphysema, idiopathic pulmonary fibrosis (IPF), or alpha-1 antitrypsin deficiency (A1AD) having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
Overall Study Adverse Event	0	8
Overall Study Withdrawal by Subject	4	4
Overall Study Protocol Violation	2	5
Overall Study Lack of Compliance	0	1
Overall Study Unspecified Reason	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MMF - Cystic Fibrosis n=33 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=35 Participants 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 n=68 Participants Total of all reporting groups
Age, Continuous	31.3 years STANDARD_DEVIATION 7.42 • n=5 Participants	54.3 years STANDARD_DEVIATION 7.93 • n=7 Participants	43.1 years STANDARD_DEVIATION 13.86 • n=5 Participants
Gender Female	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Gender Male	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation

Population: 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.

Cmax was expressed in milligrams per liter (mg/L).

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=21 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=24 Participants 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.
Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4 MPA	7.914 mg/L Standard Deviation 5.46450	5.608 mg/L Standard Deviation 2.5591
Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4 MPAG	117.210 mg/L Standard Deviation 58.9632	91.207 mg/L Standard Deviation 26.3876
Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4 AcMPAG	1.583 mg/L Standard Deviation 0.9697	1.810 mg/L Standard Deviation 0.8306

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

Cmax was expressed in mg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=20 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=22 Participants 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.
Cmax of MPA, MPAG and AcMPAG at Day 8 MPA	5.124 mg/L Standard Deviation 4.2748	6.106 mg/L Standard Deviation 3.3663
Cmax of MPA, MPAG and AcMPAG at Day 8 MPAG	100.127 mg/L Standard Deviation 54.0215	100.128 mg/L Standard Deviation 25.1228
Cmax of MPA, MPAG and AcMPAG at Day 8 AcMPAG	1.007 mg/L Standard Deviation 0.5914	1.361 mg/L Standard Deviation 0.9163

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

Cmax was expressed in mg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=17 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=21 Participants 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.
Cmax of MPA, MPAG and AcMPAG at Day 20 MPA	5.284 mg/L Standard Deviation 3.8472	6.762 mg/L Standard Deviation 3.7405
Cmax of MPA, MPAG and AcMPAG at Day 20 MPAG	93.882 mg/L Standard Deviation 37.6112	124.450 mg/L Standard Deviation 45.0613
Cmax of MPA, MPAG and AcMPAG at Day 20 AcMPAG	0.624 mg/L Standard Deviation 0.3895	1.434 mg/L Standard Deviation 1.0501

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

Cmax was expressed in mg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=15 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=12 Participants 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.
Cmax of MPA, MPAG and AcMPAG at Day 90 MPA	12.915 mg/L Standard Deviation 9.2479	7.294 mg/L Standard Deviation 3.1817
Cmax of MPA, MPAG and AcMPAG at Day 90 MPAG	104.938 mg/L Standard Deviation 44.6135	113.453 mg/L Standard Deviation 48.2935
Cmax of MPA, MPAG and AcMPAG at Day 90 AcMPAG	1.375 mg/L Standard Deviation 0.6514	1.163 mg/L Standard Deviation 0.6856

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

Cmax was expressed in micrograms per liter (mcg/L).

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=19 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=23 Participants 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.
Cmax of Free MPA at Day 4	135.275 mcg/L Standard Deviation 133.2231	84.014 mcg/L Standard Deviation 57.8348

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

Cmax was expressed in mcg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=18 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=21 Participants 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.
Cmax of Free MPA at Day 8	59.571 mcg/L Standard Deviation 35.1104	95.553 mcg/L Standard Deviation 62.6051

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

Cmax was expressed in mcg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=16 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=20 Participants 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.
Cmax of Free MPA at Day 20	51.822 mcg/L Standard Deviation 39.9533	100.094 mcg/L Standard Deviation 120.8269

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

Cmax was expressed in mcg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=11 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=10 Participants 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.
Cmax of Free MPA at Day 90	87.293 mcg/L Standard Deviation 97.6509	101.472 mcg/L Standard Deviation 93.9834

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

Population: 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.

Dose-normalized Cmax was determined (in 1 per liter \[1/L\]) by dividing the Cmax by the actual dose taken.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=21 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=24 Participants 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.
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4 MPA	0.00557 1/L Standard Deviation 0.003907	0.00422 1/L Standard Deviation 0.001924
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4 MPAG	0.08286 1/L Standard Deviation 0.037461	0.06749 1/L Standard Deviation 0.017478
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4 AcMPAG	0.001122 1/L Standard Deviation 0.0006350	0.001388 1/L Standard Deviation 0.0007160
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4 Free MPA	0.0000929 1/L Standard Deviation 0.00008796	0.0000625 1/L Standard Deviation 0.00003907

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

Population: 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.

Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=20 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=22 Participants 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.
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8 MPA	0.00356 1/L Standard Deviation 0.002769	0.00435 1/L Standard Deviation 0.002522
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8 MPAG	0.06980 1/L Standard Deviation 0.033524	0.07070 1/L Standard Deviation 0.017856
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8 AcMPA	0.000702 1/L Standard Deviation 0.0003736	0.000967 1/L Standard Deviation 0.0006297
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8 Free MPA	0.0000409 1/L Standard Deviation 0.00002274	0.0000663 1/L Standard Deviation 0.00004075

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

Population: 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.

Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=17 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=21 Participants 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.
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20 MPA	0.00395 1/L Standard Deviation 0.002619	0.00456 1/L Standard Deviation 0.002462
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20 MPAG	0.07044 1/L Standard Deviation 0.029284	0.08430 1/L Standard Deviation 0.029430
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20 AcMPAG	0.000482 1/L Standard Deviation 0.0003487	0.000969 1/L Standard Deviation 0.0006947
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20 Free MP	0.0000439 1/L Standard Deviation 0.00004750	0.0000666 1/L Standard Deviation 0.00008052

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

Population: 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.

Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=16 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=12 Participants 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.
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90 Free MPA	0.0000945 1/L Standard Deviation 0.00009640	0.0001043 1/L Standard Deviation 0.00009208
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90 MPA	0.01261 1/L Standard Deviation 0.007644	0.00742 1/L Standard Deviation 0.003631
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90 MPAG	0.10671 1/L Standard Deviation 0.037035	0.10948 1/L Standard Deviation 0.030395
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90 AcMPAG	0.001377 1/L Standard Deviation 0.0006935	0.001134 1/L Standard Deviation 0.0005100

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

Population: 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.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=21 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=24 Participants 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.
Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4 MPA	1.823 hour Standard Deviation 1.1626	2.892 hour Standard Deviation 2.9202
Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4 MPAG	3.713 hour Standard Deviation 2.4167	4.891 hour Standard Deviation 2.6546
Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4 AcMPAG	2.379 hour Standard Deviation 1.2344	3.405 hour Standard Deviation 1.9162
Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4 Free MPA	1.472 hour Standard Deviation 0.3758	1.405 hour Standard Deviation 0.4644

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

Population: 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.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=20 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=22 Participants 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.
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8 MPA	2.138 hour Standard Deviation 1.4976	1.659 hour Standard Deviation 0.9530
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8 MPAG	3.669 hour Standard Deviation 1.4773	3.647 hour Standard Deviation 1.4555
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8 AcMPAG	2.802 hour Standard Deviation 1.2418	2.546 hour Standard Deviation 1.1508
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8 Free MPA	1.272 hour Standard Deviation 0.5982	1.446 hour Standard Deviation 0.3638

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

Population: 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.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=17 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=21 Participants 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.
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20 MPA	2.293 hour Standard Deviation 1.9048	2.463 hour Standard Deviation 1.8928
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20 MPAG	3.762 hour Standard Deviation 2.2954	4.907 hour Standard Deviation 2.8568
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20 AcMPAG	2.842 hour Standard Deviation 1.7915	3.411 hour Standard Deviation 1.8799
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20 Free MPA	1.236 hour Standard Deviation 0.6144	1.366 hour Standard Deviation 0.4692

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

Population: 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.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=15 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=12 Participants 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.
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90 MPA	1.450 hour Standard Deviation 0.5251	2.143 hour Standard Deviation 2.2487
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90 MPAG	3.095 hour Standard Deviation 1.7884	4.420 hour Standard Deviation 1.9078
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90 AcMPAG	2.234 hour Standard Deviation 1.0899	3.564 hour Standard Deviation 2.3686
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90 Free MPA	1.490 hour Standard Deviation 0.0666	1.485 hour Standard Deviation 0.5282

PRIMARY outcome

Timeframe: Predose (0 hour) on Day 4 post-transplantation

Population: 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.

Cmin was expressed in mg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=21 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=25 Participants 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.
Minimum Concentration (Cmin) of MPA, MPAG and AcMPAG at Day 4 MPA	1.267 mg/L Standard Deviation 1.0082	1.094 mg/L Standard Deviation 0.8473
Minimum Concentration (Cmin) of MPA, MPAG and AcMPAG at Day 4 MPAG	66.917 mg/L Standard Deviation 41.3384	47.493 mg/L Standard Deviation 17.9747
Minimum Concentration (Cmin) of MPA, MPAG and AcMPAG at Day 4 AcMPAG	0.602 mg/L Standard Deviation 0.5628	0.733 mg/L Standard Deviation 0.4686

PRIMARY outcome

Timeframe: Predose (0 hour) on Day 8 post-transplantation

Population: 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.

Cmin was expressed in mg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=20 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=24 Participants 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.
Cmin of MPA, MPAG and AcMPAG at Day 8 AcMPAG	0.386 mg/L Standard Deviation 0.4870	0.517 mg/L Standard Deviation 0.2623
Cmin of MPA, MPAG and AcMPAG at Day 8 MPA	0.750 mg/L Standard Deviation 0.6136	0.772 mg/L Standard Deviation 0.3482
Cmin of MPA, MPAG and AcMPAG at Day 8 MPAG	54.566 mg/L Standard Deviation 51.2379	57.189 mg/L Standard Deviation 20.8518

PRIMARY outcome

Timeframe: Predose (0 hour) on Day 20 post-transplantation

Population: 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.

Cmin was expressed in mg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=18 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=22 Participants 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.
Cmin of MPA, MPAG and AcMPAG at Day 20 MPA	0.782 mg/L Standard Deviation 0.5945	1.234 mg/L Standard Deviation 0.9971
Cmin of MPA, MPAG and AcMPAG at Day 20 MPAG	58.484 mg/L Standard Deviation 29.5576	69.023 mg/L Standard Deviation 25.6603
Cmin of MPA, MPAG and AcMPAG at Day 20 AcMPAG	0.261 mg/L Standard Deviation 0.1662	0.528 mg/L Standard Deviation 0.3977

PRIMARY outcome

Timeframe: Predose (0 hour) on Day 90 post-transplantation

Population: 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.

Cmin was expressed in mg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=15 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=12 Participants 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.
Cmin of MPA, MPAG and AcMPAG at Day 90 MPA	1.103 mg/L Standard Deviation 0.7446	1.570 mg/L Standard Deviation 1.0282
Cmin of MPA, MPAG and AcMPAG at Day 90 MPAG	57.957 mg/L Standard Deviation 32.6863	80.488 mg/L Standard Deviation 37.2631
Cmin of MPA, MPAG and AcMPAG at Day 90 AcMPAG	0.449 mg/L Standard Deviation 0.3552	0.466 mg/L Standard Deviation 0.3096

PRIMARY outcome

Timeframe: Predose (0 hour) on Day 4 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

Cmin was expressed in mcg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=19 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=23 Participants 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.
Cmin of Free MPA at Day 4	40.188 mcg/L Standard Deviation 37.9357	23.711 mcg/L Standard Deviation 14.6991

PRIMARY outcome

Timeframe: Predose (0 hour) on Day 8 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

Cmin was expressed in mcg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=19 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=24 Participants 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.
Cmin of Free MPA at Day 8	18.161 mcg/L Standard Deviation 16.3831	15.669 mcg/L Standard Deviation 9.6168

PRIMARY outcome

Timeframe: Predose (0 hour) on Day 20 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

Cmin was expressed in mcg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=18 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=20 Participants 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.
Cmin of Free MPA at Day 20	12.193 mcg/L Standard Deviation 9.1443	20.237 mcg/L Standard Deviation 16.2117

PRIMARY outcome

Timeframe: Predose (0 hour) on Day 90 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

Cmin was expressed in mcg/L.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=13 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=12 Participants 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.
Cmin of Free MPA at Day 90	8.102 mcg/L Standard Deviation 3.3201	18.831 mcg/L Standard Deviation 12.6155

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

Population: 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.

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.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=21 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=23 Participants 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.
Volume of Distribution (Vz) of MPA, MPAG and AcMPAG at Day 4 MPA	345.46 Liter Standard Deviation 182.247	287.74 Liter Standard Deviation 237.295
Volume of Distribution (Vz) of MPA, MPAG and AcMPAG at Day 4 MPAG	11.681 Liter Standard Deviation 4.7587	12.062 Liter Standard Deviation 3.7316
Volume of Distribution (Vz) of MPA, MPAG and AcMPAG at Day 4 AcMPAG	1065.02 Liter Standard Deviation 611.137	705.38 Liter Standard Deviation 502.996

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

Population: 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.

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.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=20 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=21 Participants 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.
Vz of MPA, MPAG and AcMPAG at Day 8 MPA	465.45 Liter Standard Deviation 260.837	331.51 Liter Standard Deviation 150.037
Vz of MPA, MPAG and AcMPAG at Day 8 MPAG	12.168 Liter Standard Deviation 5.1048	12.740 Liter Standard Deviation 5.2593
Vz of MPA, MPAG and AcMPAG at Day 8 AcMPAG	1432.88 Liter Standard Deviation 919.423	1173.38 Liter Standard Deviation 708.767

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

Population: 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.

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.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=17 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=21 Participants 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.
Vz of MPA, MPAG and AcMPAG at Day 20 MPA	476.06 Liter Standard Deviation 267.025	257.57 Liter Standard Deviation 126.679
Vz of MPA, MPAG and AcMPAG at Day 20 MPAG	12.798 Liter Standard Deviation 5.1535	9.533 Liter Standard Deviation 3.1984
Vz of MPA, MPAG and AcMPAG at Day 20 AcMPAG	3006.18 Liter Standard Deviation 2570.205	1571.93 Liter Standard Deviation 1944.621

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

Population: 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.

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.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=15 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=12 Participants 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.
Vz of MPA, MPAG and AcMPAG at Day 90 MPA	139.48 Liter Standard Deviation 78.679	192.53 Liter Standard Deviation 226.826
Vz of MPA, MPAG and AcMPAG at Day 90 MPAG	9.254 Liter Standard Deviation 4.6738	9.201 Liter Standard Deviation 4.4274
Vz of MPA, MPAG and AcMPAG at Day 90 AcMPAG	811.15 Liter Standard Deviation 404.733	980.49 Liter Standard Deviation 473.444

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

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).

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=21 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=24 Participants 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.
Clearance (CL) of MPA, MPAG and AcMPAG at Day 4 MPA	68.471 L/hours Standard Deviation 32.7611	56.709 L/hours Standard Deviation 22.3503
Clearance (CL) of MPA, MPAG and AcMPAG at Day 4 MPAG	1.6754 L/hours Standard Deviation 0.81910	1.7615 L/hours Standard Deviation 0.46573
Clearance (CL) of MPA, MPAG and AcMPAG at Day 4 AcMPAG	206.60 L/hours Standard Deviation 151.301	140.96 L/hours Standard Deviation 110.400

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=20 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=22 Participants 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.
CL of MPA, MPAG and AcMPAG at Day 8 MPA	90.921 L/hour Standard Deviation 33.7184	81.578 L/hour Standard Deviation 63.7936
CL of MPA, MPAG and AcMPAG at Day 8 MPAG	2.3235 L/hour Standard Deviation 1.55336	1.7847 L/hour Standard Deviation 0.75624
CL of MPA, MPAG and AcMPAG at Day 8 AcMPAG	410.86 L/hour Standard Deviation 448.947	253.81 L/hour Standard Deviation 237.283

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=17 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=21 Participants 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.
CL of MPA, MPAG and AcMPAG at Day 20 MPA	83.068 L/hour Standard Deviation 27.7321	58.295 L/hour Standard Deviation 19.5800
CL of MPA, MPAG and AcMPAG at Day 20 MPAG	1.9338 L/hour Standard Deviation 0.69979	1.4788 L/hour Standard Deviation 0.44488
CL of MPA, MPAG and AcMPAG at Day 20 AcMPAG	680.68 L/hour Standard Deviation 614.970	232.34 L/hour Standard Deviation 179.449

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

Population: 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.

CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=15 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=12 Participants 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.
CL of MPA, MPAG and AcMPAG at Day 90 MPA	38.091 L/hour Standard Deviation 20.9125	36.922 L/hour Standard Deviation 15.2129
CL of MPA, MPAG and AcMPAG at Day 90 MPAG	1.5701 L/hour Standard Deviation 0.99265	1.2433 L/hour Standard Deviation 0.53337
CL of MPA, MPAG and AcMPAG at Day 90 AcMPAG	231.28 L/hour Standard Deviation 218.455	223.56 L/hour Standard Deviation 191.887

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours time milligrams per liter (hours\*\[mg/L\]).

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=21 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=24 Participants 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.
Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of MPA, MPAG and AcMPAG at Day 4 MPA	23.460 hours*(mg/L) Standard Deviation 7.8103	27.174 hours*(mg/L) Standard Deviation 10.4909
Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of MPA, MPAG and AcMPAG at Day 4 MPAG	1095.98 hours*(mg/L) Standard Deviation 659.211	829.14 hours*(mg/L) Standard Deviation 281.878
Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of MPA, MPAG and AcMPAG at Day 4 AcMPAG	10.414 hours*(mg/L) Standard Deviation 7.5535	13.672 hours*(mg/L) Standard Deviation 6.6349

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours\*(mg/L).

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=20 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=22 Participants 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.
AUC0-12 of MPA, MPAG and AcMPAG at Day 8 AcMPAG	6.064 hours*(mg/L) Standard Deviation 4.2591	9.081 hours*(mg/L) Standard Deviation 6.5063
AUC0-12 of MPA, MPAG and AcMPAG at Day 8 MPA	17.841 hours*(mg/L) Standard Deviation 8.2077	23.352 hours*(mg/L) Standard Deviation 10.7853
AUC0-12 of MPA, MPAG and AcMPAG at Day 8 MPAG	881.50 hours*(mg/L) Standard Deviation 634.587	888.96 hours*(mg/L) Standard Deviation 277.565

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours\*(mg/L).

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=17 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=21 Participants 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.
AUC0-12 of MPA, MPAG and AcMPAG at Day 20 MPA	18.925 hours*(mg/L) Standard Deviation 10.7674	28.290 hours*(mg/L) Standard Deviation 10.5485
AUC0-12 of MPA, MPAG and AcMPAG at Day 20 MPAG	812.65 hours*(mg/L) Standard Deviation 391.881	1095.37 hours*(mg/L) Standard Deviation 391.620
AUC0-12 of MPA, MPAG and AcMPAG at Day 20 AcMPAG	3.252 hours*(mg/L) Standard Deviation 2.2066	9.482 hours*(mg/L) Standard Deviation 6.6815

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

Population: 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.

AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours\*(mg/L).

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=15 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=12 Participants 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.
AUC0-12 of MPA, MPAG and AcMPAG at Day 90 MPA	32.365 hours*(mg/L) Standard Deviation 16.4658	31.864 hours*(mg/L) Standard Deviation 15.5442
AUC0-12 of MPA, MPAG and AcMPAG at Day 90 MPAG	776.28 hours*(mg/L) Standard Deviation 385.310	972.69 hours*(mg/L) Standard Deviation 530.667
AUC0-12 of MPA, MPAG and AcMPAG at Day 90 AcMPAG	7.776 hours*(mg/L) Standard Deviation 5.0791	7.219 hours*(mg/L) Standard Deviation 5.2217

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours times micrograms per liter (hours\*\[mcg/L\]).

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=19 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=22 Participants 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.
AUC0-12 of Free MPA at Day 4	135.703 hours*mcg/L Standard Deviation 120.4152	80.272 hours*mcg/L Standard Deviation 45.9523

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours\*(mcg/L).

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=17 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=21 Participants 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.
AUC0-12 of Free MPA at Day 8	61.155 hours*mcg/L Standard Deviation 26.0913	83.683 hours*mcg/L Standard Deviation 51.4228

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours\*(mcg/L).

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=16 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=20 Participants 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.
AUC0-12 of Free MPA at Day 20	48.530 hours*mcg/L Standard Deviation 30.3408	89.315 hours*mcg/L Standard Deviation 90.3819

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours\*(mcg/L).

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=11 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=10 Participants 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.
AUC0-12 of Free MPA at Day 90	68.874 hours*mcg/L Standard Deviation 64.6536	99.212 hours*mcg/L Standard Deviation 81.0812

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

Population: 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.

AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=21 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=24 Participants 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.
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 4 MPA	0.01652 hours/L Standard Deviation 0.004684	0.02016 hours/L Standard Deviation 0.007383
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 4 MPAG	0.7720 hours/L Standard Deviation 0.42519	0.6165 hours/L Standard Deviation 0.20281
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 4 AcMPAG	0.00739 hours/L Standard Deviation 0.005002	0.01056 hours/L Standard Deviation 0.005828
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 4 Free MPA	0.0000943 hours/L Standard Deviation 0.00008029	0.0000594 hours/L Standard Deviation 0.00003237

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

Population: 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.

AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=20 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=22 Participants 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.
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 8 AcMPAG	0.00426 hours/L Standard Deviation 0.002733	0.00644 hours/L Standard Deviation 0.004471
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 8 Free MPA	0.0000428 hours/L Standard Deviation 0.00001807	0.0000580 hours/L Standard Deviation 0.00003330
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 8 MPA	0.01256 hours/L Standard Deviation 0.005018	0.01624 hours/L Standard Deviation 0.007077
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 8 MPAG	0.6157 hours/L Standard Deviation 0.40835	0.6270 hours/L Standard Deviation 0.18884

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

Population: 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.

AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=17 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=21 Participants 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.
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 20 MPA	0.01402 hours/L Standard Deviation 0.007208	0.01923 hours/L Standard Deviation 0.007029
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 20 MPAG	0.6059 hours/L Standard Deviation 0.28149	0.7440 hours/L Standard Deviation 0.26032
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 20 AcMPAG	0.00239 hours/L Standard Deviation 0.001707	0.00642 hours/L Standard Deviation 0.004432
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 20 Free MPA	0.0000399 hours/L Standard Deviation 0.00003632	0.0000597 hours/L Standard Deviation 0.00006020

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

Population: 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.

AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=15 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=12 Participants 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.
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 90 MPA	0.03126 hours/L Standard Deviation 0.011529	0.03172 hours/L Standard Deviation 0.012879
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 90 MPAG	0.7887 hours/L Standard Deviation 0.31007	0.9190 hours/L Standard Deviation 0.31896
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 90 AcMPAG	0.00748 hours/L Standard Deviation 0.004735	0.00700 hours/L Standard Deviation 0.004084
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 90 Free MPA	0.0000752 hours/L Standard Deviation 0.00006364	0.00001023 hours/L Standard Deviation 0.00007888

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

MPA Free fraction (in percent \[%\]) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=19 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=22 Participants 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.
Free Fraction of Free MPA at Day 4	0.5789 percentage of free fraction Standard Deviation 0.42113	0.3208 percentage of free fraction Standard Deviation 0.16486

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=17 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=21 Participants 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.
Free Fraction of Free MPA at Day 8	0.3595 percentage of free fraction Standard Deviation 0.13517	0.3594 percentage of free fraction Standard Deviation 0.20504

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=16 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=20 Participants 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.
Free Fraction of Free MPA at Day 20	0.2922 percentage of free fraction Standard Deviation 0.19811	0.3052 percentage of free fraction Standard Deviation 0.22218

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

Population: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=11 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=10 Participants 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.
Free Fraction of Free MPA at Day 90	0.2270 percentage of free fraction Standard Deviation 0.14614	0.3020 percentage of free fraction Standard Deviation 0.13446

SECONDARY outcome

Timeframe: Day 90 post-transplantation

Population: ITT Population (total 64 participants). Here, Number of participants analyzed = participants evaluable for this outcome measure.

FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=26 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=16 Participants 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.
Forced Expiratory Volume in 1 Second (FEV1) at Day 90 Post-Transplantation	3.087 L Standard Deviation 0.9335	2.834 L Standard Deviation 0.6912

SECONDARY outcome

Timeframe: Day 90 post-transplantation

Population: ITT Population. Here, Number of participants analyzed = participants evaluable for this outcome measure.

FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Percent predicted FEV1 \[%\] = (FEV1 \[L\] / Predicted normal value FEV1 \[L\]) \* 100%

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=26 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=15 Participants 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.
Percent of Predicted FEV1 at Day 90 Post-Transplantation	81.75 percentage of predicted FEV1 Standard Deviation 19.743	90.17 percentage of predicted FEV1 Standard Deviation 20.176

SECONDARY outcome

Timeframe: Day 90 post-transplantation

Population: ITT Population. Here, Number of participants analyzed = participants evaluable for the outcome measure.

FVC at Day 90 post-transplantation is reported.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=26 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=16 Participants 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.
Forced Vital Capacity (FVC) at Day 90 Post-Transplantation	3.445 L Standard Deviation 0.9499	3.619 L Standard Deviation 1.0388

SECONDARY outcome

Timeframe: Baseline, Days 4, 8, 20 and 90 post-transplantation

Population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category, for respective arm groups.

iATP was expressed in ng/mL.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=20 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=18 Participants 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.
Change From Baseline in Intracellular Adenosine-Tri-Phosphate (iATP) Levels Day 4	24.0 ng/mL Standard Deviation 223.32	85.4 ng/mL Standard Deviation 215.78
Change From Baseline in Intracellular Adenosine-Tri-Phosphate (iATP) Levels Day 8	162.9 ng/mL Standard Deviation 294.53	144.9 ng/mL Standard Deviation 286.23
Change From Baseline in Intracellular Adenosine-Tri-Phosphate (iATP) Levels Day 20	-42.4 ng/mL Standard Deviation 382.87	-45.9 ng/mL Standard Deviation 199.20
Change From Baseline in Intracellular Adenosine-Tri-Phosphate (iATP) Levels Day 90	-164.6 ng/mL Standard Deviation 312.98	-114.7 ng/mL Standard Deviation 138.99

SECONDARY outcome

Timeframe: Baseline, Days 20 and 90 post-transplantation

Population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category, for respective arm groups.

Reported values are change in the T-cell phenotype status from baseline to Day 20 and 90 for cluster of differentiation (CD) 3, CD19, CD4, CD4CD25, CD28, CD45RA, CD45RO, CD69, CD127, and CD152.

Outcome measures

SECONDARY outcome

Timeframe: Up to Day 90

Population: Safety Population

Opportunistic infections included all infections which occurred due to aspergillus, candida, pneumocystis, cryptococcus, listeria, herpes zoster, herpes simplex, cytomegalovirus pathogens.

Outcome measures

Outcome measures
Measure	MMF - Cystic Fibrosis n=33 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=35 Participants 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.
Percentage of Participants With Opportunistic Infections	18.2 percentage of participants	20.0 percentage of participants

Adverse Events

MMF - Cystic Fibrosis

Serious events: 13 serious events

Other events: 27 other events

Deaths: 0 deaths

MMF - COPD, Emphysema, IPF, or A1AD

Serious events: 14 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MMF - Cystic Fibrosis n=33 participants at risk 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.	MMF - COPD, Emphysema, IPF, or A1AD n=35 participants at risk Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
Blood and lymphatic system disorders Leukopenia	3.0% 1/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Cardiac disorders Atrial tachycardia	3.0% 1/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Cardiac disorders Tachyarrhythmia	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Ear and labyrinth disorders Deafness	3.0% 1/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Gastrointestinal disorders Distal intestinal obstruction syndrome	3.0% 1/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Gastrointestinal disorders Ileus	6.1% 2/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Gastrointestinal disorders Pancreatitis	3.0% 1/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Gastrointestinal disorders Volvulus	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
General disorders Pyrexia	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
General disorders Sudden cardiac death	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Hepatobiliary disorders Cholangitis sclerosing	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Hepatobiliary disorders Hepatic failure	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Infections and infestations Bacterial infection	3.0% 1/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Infections and infestations Bronchopneumonia	3.0% 1/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Infections and infestations Pneumonia	3.0% 1/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Infections and infestations Viral infection	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Infections and infestations Wound infection	3.0% 1/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Injury, poisoning and procedural complications Graft dysfunction	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Investigations Antibiotic resistant Staphylococcus test positive	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Nervous system disorders Convulsion	3.0% 1/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Renal and urinary disorders Renal failure acute	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Bronchial haemorrhage	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Hydropneumorthorax	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.0% 1/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Pneumothorax	6.1% 2/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/33 • From baseline up to Day 90	8.6% 3/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Vascular disorders Haematoma	3.0% 1/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90

Other adverse events

Other adverse events
Measure	MMF - Cystic Fibrosis n=33 participants at risk 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.	MMF - COPD, Emphysema, IPF, or A1AD n=35 participants at risk Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
Blood and lymphatic system disorders Anaemia	9.1% 3/33 • From baseline up to Day 90	22.9% 8/35 • From baseline up to Day 90
Blood and lymphatic system disorders Hyperchromic anaemia	9.1% 3/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Blood and lymphatic system disorders Leukopenia	24.2% 8/33 • From baseline up to Day 90	8.6% 3/35 • From baseline up to Day 90
Blood and lymphatic system disorders Normochromic normocytic anaemia	3.0% 1/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Blood and lymphatic system disorders Thrombocytopenia	6.1% 2/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Cardiac disorders Atrial fibrillation	3.0% 1/33 • From baseline up to Day 90	34.3% 12/35 • From baseline up to Day 90
Ear and labyrinth disorders Tinnitus	9.1% 3/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Eye disorders Visual impairment	3.0% 1/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Gastrointestinal disorders Abdominal pain	0.00% 0/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Gastrointestinal disorders Abdominal pain upper	0.00% 0/33 • From baseline up to Day 90	8.6% 3/35 • From baseline up to Day 90
Gastrointestinal disorders Constipation	0.00% 0/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Gastrointestinal disorders Diarrhoea	9.1% 3/33 • From baseline up to Day 90	11.4% 4/35 • From baseline up to Day 90
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Gastrointestinal disorders Nausea	15.2% 5/33 • From baseline up to Day 90	8.6% 3/35 • From baseline up to Day 90
Gastrointestinal disorders Vomiting	12.1% 4/33 • From baseline up to Day 90	11.4% 4/35 • From baseline up to Day 90
General disorders Oedema peripheral	0.00% 0/33 • From baseline up to Day 90	8.6% 3/35 • From baseline up to Day 90
Infections and infestations Bacterial infection	9.1% 3/33 • From baseline up to Day 90	11.4% 4/35 • From baseline up to Day 90
Infections and infestations Clostridium difficile colitis	9.1% 3/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Infections and infestations Enterococcal infection	0.00% 0/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Infections and infestations Febrile infection	3.0% 1/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Infections and infestations Gastroenteritis norovirus	0.00% 0/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Infections and infestations Infection	0.00% 0/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Infections and infestations Pseudomonas infection	0.00% 0/33 • From baseline up to Day 90	8.6% 3/35 • From baseline up to Day 90
Injury, poisoning and procedural complications Anastomotic complication	9.1% 3/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Investigations Antibody test positive	0.00% 0/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Investigations C-reactive protein increased	3.0% 1/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Investigations Klebsiella test positive	0.00% 0/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Investigations Liver function test abnormal	9.1% 3/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Metabolism and nutrition disorders Hyperlipidaemia	6.1% 2/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Metabolism and nutrition disorders Hyperuricaemia	6.1% 2/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Metabolism and nutrition disorders Hypokalaemia	3.0% 1/33 • From baseline up to Day 90	8.6% 3/35 • From baseline up to Day 90
Psychiatric disorders Sleep disorder	0.00% 0/33 • From baseline up to Day 90	17.1% 6/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Bronchial polyp	15.2% 5/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Bronchostenosis	15.2% 5/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Cough	6.1% 2/33 • From baseline up to Day 90	0.00% 0/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Fibrinous bronchitis	15.2% 5/33 • From baseline up to Day 90	17.1% 6/35 • From baseline up to Day 90
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.0% 1/33 • From baseline up to Day 90	11.4% 4/35 • From baseline up to Day 90
Skin and subcutaneous tissue disorders Subcutaneous emphysema	6.1% 2/33 • From baseline up to Day 90	11.4% 4/35 • From baseline up to Day 90
Vascular disorders Circulatory collapse	0.00% 0/33 • From baseline up to Day 90	5.7% 2/35 • From baseline up to Day 90
Vascular disorders Hypertension	15.2% 5/33 • From baseline up to Day 90	2.9% 1/35 • From baseline up to Day 90

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	MMF - Cystic Fibrosis n=19 Participants 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.	MMF - COPD, Emphysema, IPF, or A1AD n=16 Participants 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.
Change From Baseline in T-Cell Phenotype CD127: Change at Day 90	-0.19 percentage of lymphocytes Standard Deviation 14.603	-2.03 percentage of lymphocytes Standard Deviation 12.509
Change From Baseline in T-Cell Phenotype CD3: Change at Day 20	-1.34 percentage of lymphocytes Standard Deviation 13.012	-3.01 percentage of lymphocytes Standard Deviation 13.075
Change From Baseline in T-Cell Phenotype CD3: Change at Day 90	1.74 percentage of lymphocytes Standard Deviation 11.433	-2.81 percentage of lymphocytes Standard Deviation 6.995
Change From Baseline in T-Cell Phenotype CD19: Change at Day 20	3.29 percentage of lymphocytes Standard Deviation 10.554	1.88 percentage of lymphocytes Standard Deviation 8.046
Change From Baseline in T-Cell Phenotype CD19: Change at Day 90	0.59 percentage of lymphocytes Standard Deviation 5.322	0.61 percentage of lymphocytes Standard Deviation 6.000
Change From Baseline in T-Cell Phenotype CD4: Change at Day 20	13.29 percentage of lymphocytes Standard Deviation 15.626	-14.71 percentage of lymphocytes Standard Deviation 24.467
Change From Baseline in T-Cell Phenotype CD4: Change at Day 90	9.00 percentage of lymphocytes Standard Deviation 26.054	-1.93 percentage of lymphocytes Standard Deviation 13.415
Change From Baseline in T-Cell Phenotype CD4CD25: Change at Day 20	2.72 percentage of lymphocytes Standard Deviation 6.877	-0.53 percentage of lymphocytes Standard Deviation 0.940
Change From Baseline in T-Cell Phenotype CD4CD25: Change at Day 90	0.89 percentage of lymphocytes Standard Deviation 1.354	-0.10 percentage of lymphocytes Standard Deviation 0.941
Change From Baseline in T-Cell Phenotype CD28: Change at Day 20	4.54 percentage of lymphocytes Standard Deviation 10.105	-4.44 percentage of lymphocytes Standard Deviation 7.635
Change From Baseline in T-Cell Phenotype CD28: Change at Day 90	10.15 percentage of lymphocytes Standard Deviation 25.362	-1.04 percentage of lymphocytes Standard Deviation 6.176
Change From Baseline in T-Cell Phenotype CD45RA: Change at Day 20	5.35 percentage of lymphocytes Standard Deviation 15.802	-5.11 percentage of lymphocytes Standard Deviation 17.327
Change From Baseline in T-Cell Phenotype CD45RA: Change at Day 90	-1.57 percentage of lymphocytes Standard Deviation 12.498	-4.88 percentage of lymphocytes Standard Deviation 13.342
Change From Baseline in T-Cell Phenotype CD45RO: Change at Day 20	-0.08 percentage of lymphocytes Standard Deviation 4.199	-2.83 percentage of lymphocytes Standard Deviation 3.285
Change From Baseline in T-Cell Phenotype CD45RO: Change at Day 90	-1.92 percentage of lymphocytes Standard Deviation 7.564	-0.43 percentage of lymphocytes Standard Deviation 7.574
Change From Baseline in T-Cell Phenotype CD69: Change at Day 20	5.68 percentage of lymphocytes Standard Deviation 10.031	0.01 percentage of lymphocytes Standard Deviation 0.328
Change From Baseline in T-Cell Phenotype CD69: Change at Day 90	-0.46 percentage of lymphocytes Standard Deviation 10.040	-0.04 percentage of lymphocytes Standard Deviation 0.237
Change From Baseline in T-Cell Phenotype CD127: Change at Day 20	-1.36 percentage of lymphocytes Standard Deviation 13.566	-3.90 percentage of lymphocytes Standard Deviation 7.227
Change From Baseline in T-Cell Phenotype CD152: Change at Day 20	-3.78 percentage of lymphocytes Standard Deviation 17.562	-10.97 percentage of lymphocytes Standard Deviation 17.935
Change From Baseline in T-Cell Phenotype CD152: Change at Day 90	-0.28 percentage of lymphocytes Standard Deviation 2.624	-15.59 percentage of lymphocytes Standard Deviation 29.715