Acute Graft-versus-Host Disease Treatment (BMT CTN 0802)

• Sponsor: Medical College of Wisconsin (Other)
• Overall Status: Completed
• CT.gov ID: NCT01002742
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), National Cancer Institute (NCI) (NIH)
• Enrollment: 236
• Locations: 36
• Arms: 2
• Actual Duration (Months): 41
• Patients Per Site: 6.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The study is a Phase III, randomized double blind, placebo controlled, and trial evaluating the addition of Mycophenolate mofetil (MMF) vs. placebo to systemic corticosteroids as initial therapy for acute Graft Vs Host Disease (GVHD). The primary endpoint will be GVHD free survival at Day 56 post randomization.

Condition or Disease	Intervention/Treatment	Phase
Graft-versus-Host Disease; Immune System Disorders	Drug: Mycophenolate Mofetil; Drug: Placebo	Phase 3

Detailed Description

Corticosteroids have been used as primary therapy for acute GVHD for many years. Historical published and unpublished data from Johns Hopkins, M. D. Anderson, University of Michigan and others defined an expected 35%-53% complete response (CR) at Day +28 of corticosteroid therapy for previously untreated patients with acute GVHD.

BMT CTN study 0302 (NCT00224874)was a randomized Phase II study evaluating etanercept, mycophenolate mofetil, denileukin diftitox or pentostatin in addition to corticosteroids. The results of that study suggested that mycophenolate mofetil produced the highest rates of CR at Day 28 and overall survival, supporting its evaluation in a Phase III study. Day 56 GVHD-free survival for the four treatment arms (all combining corticosteroids with one of the four study drugs) ranged from 39-71% across the four study arms.

Study Design

• Study Type: Interventional
• Actual Enrollment: 236 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Randomized, Double Blind, Phase III Trial Evaluating Corticosteroids With Mycophenolate Mofetil vs. Corticosteroids With Placebo as Initial Systemic Treatment of Acute Graft-Vs-Host-Disease (BMT CTN #0802)
• Actual Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Placebo Corticosteroids with placebo	Drug: Placebo; Oral dosing should be delivered in 250 mg units blinded placebo. For those < 40 kg, IV dosing should be within ± 10% of the exact dose. Intravenous doses are infused over a two-hour period. Patients who weight > 60 kg should receive placebo 1 gm PO/IV every 8 hours. Patients who weight between 40-60 kg should receive 750 mg PO/IV every 8 hours. Patients who weight <40 kg should receive 20 mg/kg IV or PO every 8 hours.; Other Names: Inactive drug
Experimental: Mycophenolate Mofetil Corticosteroids with Mycophenolate Mofetil	Drug: Mycophenolate Mofetil; Oral dosing should be delivered in 250 mg units. For those < 40 kg, IV dosing should be within ± 10% of the exact dose. Intravenous doses are infused over a two-hour period. Patients who weight > 60 kg should receive MMF 1 gm PO/IV every 8 hours. Patients who weight between 40-60 kg should receive 750 mg PO/IV every 8 hours. Patients who weight <40 kg should receive 20 mg/kg IV or PO every 8 hours.; Other Names: Cellcept® MMF

Outcome Measures

Primary Outcome Measures

1. GVHD-free Survival [Day 56]

   Success is defined as alive and free of GVHD at day 56 after randomization, all others are considered to be a study failure.

Secondary Outcome Measures

1. Percentage of Surviving Participants With Complete Response (CR) [Days 14, 28, and 56]

   CR is defined as a score of 0 for the GVHD grading in all evaluable organs.

2. Incidence of GVHD Flares Requiring Increased Therapy [Day 90]

   Flares are defined as any progression of acute GVHD after an initial response (i.e., earlier CR or PR) that requires re-escalation of steroid dosing, or initiation of additional topical or systemic therapy.

3. Incidence of Discontinuation of Immune Suppression Without Flare [Day 56, Day 180 and Day 360 post-treatment]

4. Cumulative Steroid Dose [Days 28 and 56]

   The cumulative steroid dose for each patient will be calculated by adding the doses (end of each week's dose) for each of the first four weeks of treatment, divided by the number of days of survival during this interval. The cumulative steroid dose was calculated for all patients per treatment arm and compared.

5. Incidence of Topical/Non-absorbable Therapy [Day 56]

6. Overall GVHD-free Survival Post-randomization [Months 6 and 12]

7. Incidence of Chronic GVHD [12 months post-randomization]

8. Incidence of Systemic Infections [6 Months]

   Number of participants that experienced at least one infection.

9. Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma [12 months]

10. Incidence of Cytomegalovirus (CMV) Reactivation [Year 1]

11. Cumulative Incidence of a Severe/Life-threatening/Fatal Infections [Year 1]

12. Disease-Free Survival (DFS) Post-Randomization [Year 1]

    DFS includes death or progression/relapse of malignancy

13. Treatment Related Mortality (TRM) [Year 1]

14. Change in Patient Reported Outcomes From Enrollment to Day 56 [Day 56]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Acute GVHD developing after allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells or cord blood. Recipients of non-myeloablative and myeloablative transplants are eligible.

• Acute GVHD after planned donor lymphocyte infusion or planned T cell add back are eligible.

• De novo acute GVHD requiring systemic therapy. GVHD is defined as the presence of skin rash and/or persistent nausea, vomiting, and/or diarrhea and/or cholestasis presenting in a context in which acute GVHD is likely to occur and where other etiologies such as drug rash, enteric infection, or hepatotoxic syndromes are unlikely or have been ruled out. Note that patients with stage I and II skin only (overall grade I) or isolated upper gastrointestinal (GI) involvement are eligible if the treating physician deems that systemic high-dose corticosteroid treatment is indicated.

• The patient must have had no previous systemic immune suppressive therapy for treatment of acute GVHD except for a maximum 72 hours of prior corticosteroid therapy at >0.5mg/kg methylprednisolone or equivalent after the onset of acute GVHD.

• Clinical status at enrollment to allow tapering of steroids to not less than 0.25 mg/kg/day prednisone (0.2 mg/kg/day methylprednisolone) at Day 28 of therapy.

• Absolute neutrophil count (ANC) greater than 500/µL.

• Written informed consent and/or assent from patient, parent or guardian.

• Documentation that the assent document and education materials have been provided to, and reviewed with, patients between the ages of 7 and 17.

• Patients of all ages are eligible.

• Biopsy confirmation of GVHD is recommended, but not required. Enrollment should not be delayed for biopsy or pathology results unless these are to be used to decide about whether to treat for GVHD.

Exclusion Criteria:

• Patients receiving mycophenolate mofetil or mycophenolic acid (Myfortic) within seven days of screening for enrollment.

• Patients with uncontrolled infections will be excluded. If a bacterial or viral infection is present, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. If a fungal infection is present, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.

• Relapsed/persistent malignancy requiring rapid immune suppression withdrawal.

• Patients with GVHD after an unplanned Donor Lymphocyte Infusion (DLI), i.e., DLI that was not part of their original transplant therapy plan, or DLI given for treatment of persistent or recurrent malignancy after transplantation.

• Patients unlikely to be available at the transplantation center on Day 28 and 56 of therapy.

• A clinical syndrome resembling de novo chronic GVHD developing at any time after allotransplantation.

• Patients receiving other drugs for the treatment of GVHD.

• Patients receiving methylprednisolone > 0.5 mg/kg/day (or 0.6 mg/kg/day prednisone) within 7 days before the onset of acute GVHD. If steroid therapy has been administered for treatment of a non-GVHD related condition and tapered to ≤ 0.5 mg/kg/day methylprednisolone (0.6 mg/kg/day prednisone) for seven or more days before the onset of acute GVHD, the patient is eligible.

• Patients who are pregnant, breast feeding, or, if sexually active, unwilling to use effective birth control for the duration of the study. Available evidence and/or expert consensus is inconclusive or is inadequate for determining infant risk when used during breastfeeding, therefore breast feeding patients are not eligible.

• Adults unable to provide informed consent.

• Patients on dialysis.

• Patients with severe hepatic Veno-Occlusive Disease (VOD) or sinusoidal obstruction syndrome who in the judgement of the treating physician are not expected to have normalized bilirubin by Day 56 after enrollment.

• Patients with a history of intolerance/allergy to MMF.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope National Medical Center	Duarte	California	United States	91010
2	University of California San Diego Medical Center	La Jolla	California	United States	92093
3	Stanford Hospital and Clinics	Stanford	California	United States	94305
4	Colorado Blood Cancer Institute	Denver	Colorado	United States	80218
5	University of Florida College of Medicine	Gainesville	Florida	United States	32610
6	BMT Program at Northside Hospital	Atlanta	Georgia	United States	30342
7	Ann & Robert Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611
8	Rush University Medical Center	Chicago	Illinois	United States	60612
9	Indiana BMT at Beech Grove	Beech Grove	Indiana	United States	46107
10	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
11	University of Maryland Medical Systems	Baltimore	Maryland	United States	21201
12	Johns Hopkins University	Baltimore	Maryland	United States	21231
13	Tufts Medical Center	Boston	Massachusetts	United States	02111
14	DFCI, Massachusetts General Hospital	Boston	Massachusetts	United States	02114
15	Dana Farber Cancer Institute, Brigham & Women's Hospital	Boston	Massachusetts	United States	02115
16	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109
17	University of Minnesota	Minneapolis	Minnesota	United States	55455
18	Mayo Clinic	Rochester	Minnesota	United States	55905
19	Washington University, Barnes Jewish Hospital	Saint Louis	Missouri	United States	63110
20	Hackensack Univ. Medical Center	Hackensack	New Jersey	United States	07601
21	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
22	Weill Cornell Medical College, NY Presbyterian Hospital	New York	New York	United States	10065
23	University of North Carolina Hospital at Chapel Hill	Chapel Hill	North Carolina	United States	27599-7305
24	Levine Children's Hospital, Carolinas Medical Center	Charlotte	North Carolina	United States	28232
25	Duke University Medical Center	Durham	North Carolina	United States	27705
26	Ohio State University	Columbus	Ohio	United States	43210
27	Oregon Health and Science University	Portland	Oregon	United States	97239
28	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104
29	Medical University of South Carolina	Charleston	South Carolina	United States	29425
30	Avera Hematology & Transplant Center	Sioux Falls	South Dakota	United States	57105
31	Baylor University Medical Center	Dallas	Texas	United States	75246
32	University of Texas, MD Anderson Cancer Research Center	Houston	Texas	United States	77030
33	Texas Transplant Institute	San Antonio	Texas	United States	78229
34	Virginia Commonwealth University	Richmond	Virginia	United States	23298
35	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
36	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53211

Sponsors and Collaborators

• Medical College of Wisconsin
• National Heart, Lung, and Blood Institute (NHLBI)
• National Cancer Institute (NCI)

Investigators

• Study Director: Mary Horowitz, MD, Center for International Blood and Marrow Transplant Research

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Blood and Marrow Transplant Clinical Trials Network

Publications

None provided.

• Responsible Party: Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT01002742
• Other Study ID Numbers: BMTCTN0802; U01HL069294; BMT CTN 0802; U01HL069294-06; 5U24CA076518
• First Posted: Oct 27, 2009
• Last Update Posted: Oct 27, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Medical College of Wisconsin: GVHD
• Additional relevant MeSH terms: Graft vs Host Disease; Immune System Diseases; Mycophenolic Acid

Study Results

Participant Flow

Recruitment Details	Participants were enrolled from February 17, 2010 to November 11, 2011 from 36 different transplant centers.

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Period Title: Overall Study
STARTED	119	117
COMPLETED	119	116
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Placebo	Mycophenolate Mofetil	Total
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil	Total of all reporting groups
Overall Participants	119	116	235
Age, Customized (years) [Median (Full Range) ]
Median Age	52.9	54	53.8
Sex: Female, Male (Count of Participants)
Female	41 34.5%	45 38.8%	86 36.6%
Male	78 65.5%	71 61.2%	149 63.4%
Primary Disease (participants) [Number]
Acute myeloid leukemia	47 39.5%	41 35.3%	88 37.4%
Acute lymphoblastic leukemia	14 11.8%	16 13.8%	30 12.8%
Chronic myeloid leukemia	5 4.2%	3 2.6%	8 3.4%
Myelodysplastic syndrome	17 14.3%	20 17.2%	37 15.7%
Lymphoma	17 14.3%	17 14.7%	34 14.5%
Other	19 16%	19 16.4%	38 16.2%
Unrelated Donor (participants) [Number]
Number [participants]	72 60.5%	66 56.9%	138 58.7%
Graft Source (participants) [Number]
Bone marrow	16 13.4%	23 19.8%	39 16.6%
Peripheral blood stem cell	102 85.7%	91 78.4%	193 82.1%
Cord blood	1 0.8%	2 1.7%	3 1.3%
Myeloablative Conditioning (participants) [Number]
Number [participants]	74 62.2%	74 63.8%	148 63%
Grade of acute Graft-Vs-Host-Disease (GVHD) at Diagnosis (participants) [Number]
Grade I	16 13.4%	11 9.5%	27 11.5%
Grade II	62 52.1%	68 58.6%	130 55.3%
Grade III	34 28.6%	30 25.9%	64 27.2%
Grade IV	7 5.9%	7 6%	14 6%
Cutaneous involvement at onset (participants) [Number]
No Rash	36 30.3%	31 26.7%	67 28.5%
Maculopapular Rash, <25% of Body Surface	14 11.8%	11 9.5%	25 10.6%
Maculopapular Rash, 25-50% of Body Surface	21 17.6%	27 23.3%	48 20.4%
Generalized Erythroderma	44 37%	46 39.7%	90 38.3%
Erythroderma and Bullae Formation/Desquamation	4 3.4%	1 0.9%	5 2.1%
Upper GI Abnormalities at Diagnosis (participants) [Number]
No Protracted Nausea and Vomiting	82 68.9%	85 73.3%	167 71.1%
Persistent Nausea, Vomiting or Anorexia	37 31.1%	31 26.7%	68 28.9%
Lower GI Abnormalities at Diagnosis (participants) [Number]
No Diarrhea	66 55.5%	57 49.1%	123 52.3%
Diarrhea Less ≤ 500 mL/day	19 16%	21 18.1%	40 17%
Diarrhea >500 but ≤ 1000 mL/day	14 11.8%	21 18.1%	35 14.9%
Diarrhea >1000 but ≤ 1500 mL/day	9 7.6%	8 6.9%	17 7.2%
Diarrhea >1500 mL/day	11 9.2%	7 6%	18 7.7%
Stool with Frank Blood or Melena	0 0%	2 1.7%	2 0.9%
Liver Abnormalities at Diagnosis (participants) [Number]
Bilirubin <2 mg/dL	110 92.4%	106 91.4%	216 91.9%
Bilirubin 2-3 mg/dL	5 4.2%	1 0.9%	6 2.6%
Bilirubin 3.1-6 mg/dL	4 3.4%	6 5.2%	10 4.3%
Bilirubin 6.1-15 mg/dL	0 0%	2 1.7%	2 0.9%
Bilirubin >15 mg/dL	0 0%	1 0.9%	1 0.4%

Outcome Measures

1. Primary Outcome

Title	GVHD-free Survival
Description	Success is defined as alive and free of GVHD at day 56 after randomization, all others are considered to be a study failure.
Time Frame	Day 56

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	119	116
GVHD free	60 50.4%	69 59.5%
Study Failure	59 49.6%	47 40.5%

2. Secondary Outcome

Title	Percentage of Surviving Participants With Complete Response (CR)
Description	CR is defined as a score of 0 for the GVHD grading in all evaluable organs.
Time Frame	Days 14, 28, and 56

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	119	116
Day 14	49.6 41.7%	44 37.9%
Day 28	44.5 37.4%	46.6 40.2%
Day 56	53.8 45.2%	60.3 52%

3. Secondary Outcome

Title	Incidence of GVHD Flares Requiring Increased Therapy
Description	Flares are defined as any progression of acute GVHD after an initial response (i.e., earlier CR or PR) that requires re-escalation of steroid dosing, or initiation of additional topical or systemic therapy.
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	119	116
Number [participants]	16 13.4%	8 6.9%

4. Secondary Outcome

Title	Incidence of Discontinuation of Immune Suppression Without Flare
Time Frame	Day 56, Day 180 and Day 360 post-treatment

Outcome Measure Data

Analysis Population Description

No data collected

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	0	0

5. Secondary Outcome

Title	Cumulative Steroid Dose
Description	The cumulative steroid dose for each patient will be calculated by adding the doses (end of each week's dose) for each of the first four weeks of treatment, divided by the number of days of survival during this interval. The cumulative steroid dose was calculated for all patients per treatment arm and compared.
Time Frame	Days 28 and 56

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	119	116
Day 28	0.63	0.60
Day 56	0.20	0.17

6. Secondary Outcome

Title	Incidence of Topical/Non-absorbable Therapy
Time Frame	Day 56

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	119	116
Number [participants]	81 68.1%	77 66.4%

7. Secondary Outcome

Title	Overall GVHD-free Survival Post-randomization
Time Frame	Months 6 and 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	119	116
6 Months	73.4 61.7%	72.0 62.1%
12 Months	64.7 54.4%	57.8 49.8%

8. Secondary Outcome

Title	Incidence of Chronic GVHD
Time Frame	12 months post-randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	119	116
Number (95% Confidence Interval) [percentage of participants]	43.3 36.4%	41.5 35.8%

9. Secondary Outcome

Title	Incidence of Systemic Infections
Description	Number of participants that experienced at least one infection.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	119	116
Number [participants]	77 64.7%	81 69.8%

10. Secondary Outcome

Title	Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	119	116
Number [participants]	4 3.4%	6 5.2%

11. Secondary Outcome

Title	Incidence of Cytomegalovirus (CMV) Reactivation
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	119	116
Number [percentage of participants]	39 32.8%	44 37.9%

12. Secondary Outcome

Title	Cumulative Incidence of a Severe/Life-threatening/Fatal Infections
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	119	116
Number (95% Confidence Interval) [percentage of participants]	42.9 36.1%	44.5 38.4%

13. Secondary Outcome

Title	Disease-Free Survival (DFS) Post-Randomization
Description	DFS includes death or progression/relapse of malignancy
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	119	116
Number (95% Confidence Interval) [percentage of participants]	63 52.9%	53.9 46.5%

14. Secondary Outcome

Title	Treatment Related Mortality (TRM)
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	119	116
Number (95% Confidence Interval) [percentage of participants]	21.5 18.1%	21.8 18.8%

15. Secondary Outcome

Title	Change in Patient Reported Outcomes From Enrollment to Day 56
Time Frame	Day 56

Outcome Measure Data

Analysis Population Description

No data collected

Arm/Group Title	Placebo	Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo	Corticosteroids with Mycophenolate Mofetil
Measure Participants	0	0

Adverse Events

Time Frame	1 year following initiation of therapy.
Adverse Event Reporting Description	Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
Arm/Group Title	Placebo		Mycophenolate Mofetil
Arm/Group Description	Corticosteroids with placebo		Corticosteroids with Mycophenolate Mofetil
All Cause Mortality
	Placebo		Mycophenolate Mofetil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Mycophenolate Mofetil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/119 (10.9%)		13/116 (11.2%)
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura	1/119 (0.8%)	1	0/116 (0%)	1
Cardiac disorders
Atrial fibrillation	0/119 (0%)		1/116 (0.9%)	1
Gastrointestinal disorders
Vomiting	0/119 (0%)		1/116 (0.9%)	1
Diarrhoea	0/119 (0%)		1/116 (0.9%)	1
Gastrointestinal haemorrhage	0/119 (0%)		1/116 (0.9%)	1
Hepatobiliary disorders
Hepatic failure	1/119 (0.8%)	1	0/116 (0%)	1
Infections and infestations
Sepsis	0/119 (0%)		1/116 (0.9%)	1
Septic shock	2/119 (1.7%)	2	0/116 (0%)	2
Injury, poisoning and procedural complications
Hip fracture	1/119 (0.8%)	1	0/116 (0%)	1
Investigations
Transaminases increased	0/119 (0%)		1/116 (0.9%)	1
Musculoskeletal and connective tissue disorders
Fistula	1/119 (0.8%)	1	0/116 (0%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder	0/119 (0%)		1/116 (0.9%)	1
Acute myeloid leukaemia	1/119 (0.8%)	1	0/116 (0%)	1
Nervous system disorders
Cerebellar ataxia	0/119 (0%)		1/116 (0.9%)	1
Syncope	0/119 (0%)		1/116 (0.9%)	1
Reversible posterior leukoencephalopathy syndrome	1/119 (0.8%)	1	0/116 (0%)	1
Renal and urinary disorders
Renal failure	0/119 (0%)		1/116 (0.9%)	1
Haematuria	3/119 (2.5%)	3	0/116 (0%)	3
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	0/119 (0%)		1/116 (0.9%)	1
Respiratory failure	1/119 (0.8%)	1	0/116 (0%)	1
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome	0/119 (0%)		1/116 (0.9%)	1
Surgical and medical procedures
Vertebroplasty	1/119 (0.8%)	1	0/116 (0%)	1
Vascular disorders
Orthostatic hypotension	0/119 (0%)		1/116 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Placebo		Mycophenolate Mofetil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/119 (0%)		0/116 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.