A Study to Assess the Effect of CellCept (Mycophenolate M... | NCT00683930

NCT00683930

Status Module

Name	Class
Aspreva Pharmaceuticals	INDUSTRY

Label	Type	Description	Intervention Names
Mycophenolate Mofetil (MMF) 2 g/Day	Experimental	Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks	Drug: Mycophenolate Mofetil 2 g/Day
Mycophenolate Mofetil (MMF) 3 g/Day	Experimental	Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks	Drug: Mycophenolate Mofetil (MMF) 3 g/Day
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Mycophenolate Mofetil 2 g/Day	Drug	Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks	Mycophenolate Mofetil (MMF) 2 g/Day

Measure	Description	Time Frame
Percentage of Patients Achieving Responder Status at Week 52	The proportion of subjects achieving responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52) in the two active treatment groups combined (2 g/day and 3 g/day mycophenolate mofetil) compared with the placebo group	52 weeks

Measure	Description	Time Frame
Time to Initial Response	Time to initial response defined as the time that the subject first demonstrated responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52)	up to 52 weeks
Time to Sustained Response

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California	90095	United States

PubMed Identifier	Type	Citation	Retractions
20410913	Derived	Beissert S, Mimouni D, Kanwar AJ, Solomons N, Kalia V, Anhalt GJ. Treating pemphigus vulgaris with prednisone and mycophenolate mofetil: a multicenter, randomized, placebo-controlled trial. J Invest Dermatol. 2010 Aug;130(8):2041-8. doi: 10.1038/jid.2010.91. Epub 2010 Apr 22.

ID	Title	Description
FG000	Placebo	Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
FG001	MMF 2 g/Day

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Patients Achieving Responder Status at Week 52

The proportion of subjects achieving responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52) in the two active treatment groups combined (2 g/day and 3 g/day mycophenolate mofetil) compared with the placebo group

Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day or 3 g/day = 58.

Posted

Number

Percentage of Participants

52 weeks

ID	Title	Description
OG000	Placebo	Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
OG001	MMF 2 g/Day and MMF 3 g/Day Groups Combined	MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks

Units	Counts
Participants	OG00036 OG00158

Title

Denominators

Categories

Title	Measurements
	OG00063.9 OG00169.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact	Alpha = 0.025	0.6558		Treatment difference in response rate	5.1				97.5	-17.4	27.6				No	Superiority or Other

Secondary

Time to Initial Response

Time to initial response defined as the time that the subject first demonstrated responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52)

Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 7; MMF 2 g/day or 3 g/day = 58, subjects censored = 10.

Posted

Median

Inter-Quartile Range

Weeks

up to 52 weeks

ID	Title	Description
OG000	Placebo	Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
OG001	MMF 2 g/Day and MMF 3 g/Day Groups Combined	MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks

Units	Counts
Participants	OG000

Secondary

Time to Sustained Response

Time to sustained response is defined as the week the subject first demonstrates both of the conditions of responder status provided the conditions are maintained through to study termination at Week 52. If a subject does not have a sustained response, time to sustained response is censored on the last day of the study.

Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 20; MMF 2 g/day or 3 g/day = 58, subjects censored = 23.

Posted

Median

Full Range

Weeks

up to 52 weeks

ID	Title	Description
OG000	Placebo	Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
OG001	MMF 2 g/Day and MMF 3 g/Day Groups Combined	MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks

Units	Counts
Participants

Secondary

Duration of Prednisone Maintenance Dosing

The duration of prednisone maintenance dosing was defined as the number of days that subjects maintained a prednisone dose of not more than 10 mg/day in the absence of new persistent lesions.

Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day = 21; MMF 3 g/day = 37; MMF Groups Combined (2 g/day or 3 g/day) = 58.

Posted

Median

Inter-Quartile Range

Days

52 weeks

ID	Title	Description
OG000	Placebo	Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
OG001	MMF 2 g/Day and MMF 3 g/Day Groups Combined	MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
OG002	Mycophenolate Mofetil 2 g/Day	MMF 500 mg tablets; 4 tablets twice daily for 52 weeks
OG003	Mycophenolate Mofetil 3 g/Day

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Food Poisoning	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Pemphigus	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Cardiovascular Insufficiency	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Varicella	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Cataract	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0014 affected21 at risk EG0023 affected37 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0011 affected21 at risk EG0025 affected37 at risk
Rhinitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Laryngitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Pharyngitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Sinusitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Tonsillitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Oral Candidiasis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0011 affected21 at risk EG0029 affected37 at risk
Candidiasis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0011 affected21 at risk EG0021 affected37 at risk
Skin Candida	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Skin Infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0012 affected21 at risk EG0021 affected37 at risk
Furuncle	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Paronychia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Pyoderma	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Bronchitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0021 affected37 at risk
Bronchitis Acute	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Pneumonia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Pneumonia Primary Atypical	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0010 affected21 at risk EG0024 affected37 at risk
Cystitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Pyelonephritis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Urethritis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Herpes Simplex	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0012 affected21 at risk EG0022 affected37 at risk
Herpetic Gingivostomatitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Herpes Zoster	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Folliculitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Bacteriuria	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Bacterial Infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Tinea Versicolour	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0022 affected37 at risk
Body Tinea	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Viral Infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Bronchitis Viral	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Gastroenteritis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Dysentery	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Tooth Abscess	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Fungal Skin Infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Influenza	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Molluscum Contagiosum	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Anogenital Warts	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Pemphigus	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG00012 affected36 at risk EG0017 affected21 at risk EG00210 affected37 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0024 affected37 at risk
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0012 affected21 at risk EG0021 affected37 at risk
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Pruritus Generalised	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0011 affected21 at risk EG0021 affected37 at risk
Alopecia Effluvium	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Heat Rash	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Swelling Face	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0003 affected36 at risk EG0011 affected21 at risk EG0021 affected37 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Purpura Senile	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0021 affected37 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Skin Hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Nausea	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0024 affected37 at risk
Vomiting	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0011 affected21 at risk EG0021 affected37 at risk
Constipation	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0012 affected21 at risk EG0023 affected37 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0003 affected36 at risk EG0011 affected21 at risk EG0023 affected37 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0003 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Frequent Bowel Movements	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0021 affected37 at risk
Cheilitis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Lip Ulceration	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Oral Soft Tissue Disorder	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Aphthous Stomatitis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Mouth Ulceration	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Oral Mucosa Erosion	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Rectal Tenesmus	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Toothache	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Flatulence	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Gastritis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Enteritis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Stomach Discomfort	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Oral Pain	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Odynophagia	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Oral Discomfort	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Salivary Hypersecretion	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Anal Fissure	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Loose Tooth	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Gingivitis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Pyrexia	General disorders	MedDRA (9.1)	Systematic Assessment	EG0003 affected36 at risk EG0014 affected21 at risk EG0023 affected37 at risk
Fatigue	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0022 affected37 at risk
Asthenia	General disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Pain	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0022 affected37 at risk
Chest Pain	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Irritability	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0021 affected37 at risk
Influenza Like Illness	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Chest Discomfort	General disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Oedema Peripheral	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0021 affected37 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0011 affected21 at risk EG0023 affected37 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Sensation of Heaviness	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0013 affected21 at risk EG0022 affected37 at risk
Joint Stiffness	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0023 affected37 at risk
Muscle Twitching	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0011 affected21 at risk EG0021 affected37 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Myopathy Steroid	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Muscle Rigidity	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Headache	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0011 affected21 at risk EG0026 affected37 at risk
Dysgeusia	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0012 affected21 at risk EG0022 affected37 at risk
Lethargy	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Somnolence	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Migraine	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Migraine With Aura	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Dizziness	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Post Herpetic Neuralgia	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Tremor	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Dyskinesia	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0013 affected21 at risk EG0023 affected37 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Pharyngolaryngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0003 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Bronchial Hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Lung Infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Arthropod Bite	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Arthropod Sting	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Ear Abrasion	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Joint Sprain	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0012 affected21 at risk EG0020 affected37 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Polymenorrhoea	Reproductive system and breast disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Erectile Dysfunction	Reproductive system and breast disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Perineal Pain	Reproductive system and breast disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Vaginal Erosion	Reproductive system and breast disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (9.1)	Systematic Assessment	EG0003 affected36 at risk EG0011 affected21 at risk EG0021 affected37 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Thrombocythaemia	Blood and lymphatic system disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Conjunctivitis	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0021 affected37 at risk
Vision Blurred	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Visual Disturbance	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Cataract	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Glaucoma	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Lacrimation Increased	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Abnormal Sensation in Eye	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Weight Increased	Investigations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0023 affected37 at risk
Weight Decreased	Investigations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Blood Glucose Increased	Investigations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Electrocardiogram ST-T Change	Investigations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Culture Urine Positive	Investigations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Sputum Culture Positive	Investigations	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Intraocular Pressure Increased	Investigations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
White Blood Cells Urine	Investigations	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Hypertension	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0004 affected36 at risk EG0013 affected21 at risk EG0023 affected37 at risk
Venous Thrombosis	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Tachycardia	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Palpitations	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Depression	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Insomnia	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Libido Decreased	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Sleep Disorder	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk
Nervousness	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Depressed Mood	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Dysuria	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Cushingoid	Endocrine disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0022 affected37 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Allergy to Arthropod Bite	Immune system disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Central Obesity	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0010 affected21 at risk EG0021 affected37 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Iron Deficiency	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected36 at risk EG0010 affected21 at risk EG0020 affected37 at risk
Skin Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 affected36 at risk EG0011 affected21 at risk EG0020 affected37 at risk

ID	Title	Description
BG000	Placebo	Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
BG001	MMF 2 g/Day	Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
BG002	MMF 3 g/Day	Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
BG003	Total	Total of all reporting groups

ID	Term
D012872	Skin Diseases, Vesiculobullous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005227	Fatty Acids
D008055	Lipids

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks	4	36	31	36
EG001	MMF 2 g/Day	Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks	1	21	20	21
EG002	MMF 3 g/Day	Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks	3	37	32	37