OPERA Study: A Study of Two Dosing Regimens of CellCept (... | NCT02005562

NCT02005562

Status Module

Sponsor/Collaborators Module

Oversight Module

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Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

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Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mycophenolate Mofetil, Adapted Dose	Experimental	Participants received 3 grams (g) mycophenolate mofetil (MMF) tablets per os (p.o.) in divided doses (every 12 hours [q12h]) adapted to mycophenolic acid (MPA) by area under the curve (AUC) beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing through Week 52. In addition, induction by interleukin-2R (IL-2R) was administered at Day 0 per standard of care at the site at the investigator's discretion. At 72 hours post-transplantation, participants received cyclosporine 100-1500 nanograms (ng) per (/) milliliter (mL) from Day 0 to (-) Week 4, 800-1200 ng/mL from Week 4 - Week 12 and 500-800 ng/mL from Week 12 - Week 52. Solumedrol 500 mg intravenously (i.v.) was administered before or after the transplantation, and 0.5 milligrams (mg) per kilogram (kg) p.o. daily from Day 1 - Day 7.	Drug: mycophenolate mofetil Drug: anti-IL-2R Drug: methylprednisolone Drug: cyclosporine
Mycophenolate Mofetil, Fixed Dose	Active Comparator	Participants received 2 g MMF tablets p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing through Week 52. In addition, induction by IL-2R was administered at Day 0 per standard of care at the site at the investigators discretion. At 72 hours post-transplantation, participants received cyclosporine 100-1500 ng/mL from Day 0 - Week 4, 800-1200 ng/mL from Week 4 - Week 12 and 500-800 ng/mL from Week 12 - Week 52. Solumedrol 500 mg i.v. was administered before or after the transplantation, and 0.5 mg/kg p.o. daily from Day 1 - Day 7.	Drug: mycophenolate mofetil Drug: anti-IL-2R Drug: methylprednisolone Drug: cyclosporine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mycophenolate mofetil	Drug	3 g p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing to Week 52, adapted to MPA by AUC on Weeks 2, 6, 12, 26, and 52 to obtain AUC0-12 of 50 milligrams (mg) multiplied by (*) height (h)/ liter(L).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Before Week 12 or Acute Subclinical Rejection on Protocol Biopsy at Week 12	BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10 percent (%) compared to baseline (BL) values and BPAR of Grade greater than or equal to (≥) 1 according to Banff 1997 classification at Week 12.	Week 12

Secondary Outcomes

Measure	Description	Time Frame
Serum Creatinine Values [Micromoles Per Liter (µmol/L)]	The mean serum creatinine values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52.	Weeks 2, 4, 6, 12, 16, 26, 39, and 52
Creatinine Clearance Values Estimated With the Cockcroft-Gault Equation (Milliliters Per Minute [mL/Min])

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Chair

References Module

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IPD Sharing Statement Module

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Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Mycophenolate Mofetil, Adapted Dose	Participants received mycophenolate mofetil (MMF), 3 grams (g), tablets or capsules, orally (PO), every 12 hours (q12h) adapted to mycophenolic acid (MPA) by area under the curve (AUC) on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a 2 hour postdose (C2) level equal to (=) 1000 to 1500 nanograms per milliliter (ng/mL) from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 milligrams (mg), intravenously (IV), on Day -1 or Day 0, and 0.5 mg per kilogram (mg/kg), PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-interleukin (IL)-2R, per the investigator's discretion.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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Condition Browse Module

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Intervention Browse Module

Masking Info

Intent-to-treat (ITT) population, all randomized renal transplant recipients who received at least 1 dose of MMF.

Arm/Group Information

ID	Title	Description
BG000	Mycophenolate Mofetil, Adapted Dose	Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
BG001	Mycophenolate Mofetil, Fixed Dose	Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00024.2 OG00119.8

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		Chi-squared		0.479													No	Superiority or Other

Secondary

Serum Creatinine Values [Micromoles Per Liter (µmol/L)]

The mean serum creatinine values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52.

ITT population; number (n) = number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

µmol/L

Weeks 2, 4, 6, 12, 16, 26, 39, and 52

ID	Title	Description
OG000	Mycophenolate Mofetil, Adapted Dose	Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
OG001	Mycophenolate Mofetil, Fixed Dose	Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.

Secondary

Creatinine Clearance Values Estimated With the Cockcroft-Gault Equation (Milliliters Per Minute [mL/Min])

The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the Cockcroft-Gault equation.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

mL/min

Weeks 2, 4, 6, 12, 16, 26, 39, and 52

ID	Title	Description
OG000	Mycophenolate Mofetil, Adapted Dose	Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
OG001	Mycophenolate Mofetil, Fixed Dose	Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.

Secondary

Creatinine Clearance Values Estimated With the Modification of Diet in Renal Disease (MDRD) Simplified Equation

The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the MDRD simplified equation. For males, the MDRD simplified equation was defined as MDRD (mL/min/1.73 square meters [m^2]) =186 multiplied by (*) serum creatinine in mg/L raised to the power of (^) -1.154 * age ^ -0.203. For females, the MDRD simplified equation was defined as MDRD (mL/min/1.73 m^2) = males formula * 0.742.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

mL/min/1.73 m^2

Weeks 2, 4, 6, 12, 16, 26, 39, and 52

ID	Title	Description
OG000	Mycophenolate Mofetil, Adapted Dose	Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
OG001	Mycophenolate Mofetil, Fixed Dose	Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.

Secondary

Time to Occurrence of First BPAR Between Day 0 and Week 52 - Percentage of Participants With an Event

BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection at Week 12 was included in the analysis. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10% compared to BL values and BPAR of Grade ≥1 according to Banff 1997 classification at Week 12. The occurrence of the first BPAR was defined as the time from randomization to the first recorded BPAR between Day 0 and Week 52. The results of protocol biopsies at Week 12 were taken into account. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.

ITT population

Posted

Number

percentage of participants

Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52

ID	Title	Description
OG000	Mycophenolate Mofetil, Adapted Dose	Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
OG001	Mycophenolate Mofetil, Fixed Dose

Secondary

Time to Occurrence of First BPAR Between Day 0 and Week 52

ITT population

Posted

Median

95% Confidence Interval

days

Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52

ID	Title	Description
OG000	Mycophenolate Mofetil, Adapted Dose	Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
OG001	Mycophenolate Mofetil, Fixed Dose

Secondary

Percentage of Participants With at Least One BPAR at Week 12 and Week 52

BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.

ITT population; only participants with at least one assessed biopsy were included in the analysis.

Posted

Number

percentage of participants

Weeks 12 and 52

ID	Title	Description
OG000	Mycophenolate Mofetil, Adapted Dose	Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
OG001	Mycophenolate Mofetil, Fixed Dose	Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.

Secondary

Graft Histology - Percentage of Participants With at Least One Borderline Lesion at Week 12 and Week 52

Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.

ITT population

Posted

Number

percentage of participants

Weeks 12 and 52

ID	Title	Description
OG000	Mycophenolate Mofetil, Adapted Dose	Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
OG001	Mycophenolate Mofetil, Fixed Dose	Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.

Secondary

Graft Histology - Percentage of Participants With at Least One Chronic Graft Nephropathy at Week 12 and Week 52

Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.

ITT population

Posted

Number

percentage of participants

Weeks 12 and 52

ID	Title	Description
OG000	Mycophenolate Mofetil, Adapted Dose	Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
OG001	Mycophenolate Mofetil, Fixed Dose	Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.

Secondary

Graft Loss - Percentage of Participants With an Event

Graft loss was defined as physical loss (nephrectomy), functional loss [necessitating maintenance dialysis for greater than (>)8 weeks], retransplant or death. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.

ITT population

Posted

Number

percentage of participants

Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52

ID	Title	Description
OG000	Mycophenolate Mofetil, Adapted Dose	Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
OG001	Mycophenolate Mofetil, Fixed Dose	Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.

Secondary

Time to Graft Loss

The median time, in days, from randomization to graft loss event. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.

ITT population

Posted

Median

Full Range

days

Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52

ID	Title	Description
OG000	Mycophenolate Mofetil, Adapted Dose	Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
OG001	Mycophenolate Mofetil, Fixed Dose	Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.

Secondary

Participant Survival

Participants survival was defined as the percentage of participants living with or without a functioning graft between Weeks 0 and 52. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.

ITT population

Posted

Number

percentage of participants

Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52

ID	Title	Description
OG000	Mycophenolate Mofetil, Adapted Dose	Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
OG001	Mycophenolate Mofetil, Fixed Dose	Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Mycophenolate Mofetil, Adapted Dose	Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.			106	127	120	127
EG001	Mycophenolate Mofetil, Fixed Dose	Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.			94	125	115	125

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cytomegalovirus infection	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG00018 affected127 at risk EG0017 affected125 at risk
Agranulocytosis	Blood and lymphatic system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0012 affected125 at risk
Blood creatinine increased	Investigations	MedDRA (9.0)	Non-systematic Assessment	EG00015 affected127 at risk EG00110 affected125 at risk
Kidney transplant rejection	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG00049 affected127 at risk EG00139 affected125 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG00014 affected127 at risk EG00111 affected125 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0012 affected125 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk
Lymphoproliferative disorder	Blood and lymphatic system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0003 affected127 at risk EG0013 affected125 at risk
Angina pectoris	Cardiac disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0012 affected125 at risk
Cardiac failure	Cardiac disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Myocardial infarction	Cardiac disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Tachyarrhyrhmia	Cardiac disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Hyperparathyroidism tertiary	Endocrine disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0003 affected127 at risk EG0014 affected125 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Vomiting	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Aplasia	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Asthenia	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Extravasation	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
General physical health deterioration	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Hyperthermia	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Inflammation	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Oedema	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk
Oedema peripheral	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Pyrexia	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0003 affected127 at risk EG0012 affected125 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Cytolytic hepatitis	Hepatobiliary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0002 affected127 at risk EG0011 affected125 at risk
Bronchitis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0012 affected125 at risk
Bronchitis acute	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Candida sepsis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Gastroenteritis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0012 affected125 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk
Helicobacter gastritis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Herpes zoster	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Incision site abscess	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Infection	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Influenza	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0002 affected127 at risk EG0010 affected125 at risk
Klebsiella sepsis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Otitis externa	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Pharyngitis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0012 affected125 at risk
Pyelonephritis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0008 affected127 at risk EG0017 affected125 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0009 affected127 at risk EG0015 affected125 at risk
Renal cyst infection	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk
Sepsis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0012 affected125 at risk
Septic shock	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Tuberculosis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Urinary tract infection	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0002 affected127 at risk EG0013 affected125 at risk
Viral infection	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0012 affected125 at risk
Blood creatinine abnormal	Investigations	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0013 affected125 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0002 affected127 at risk EG0010 affected125 at risk
Benign colonic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Epstein-Barr virus associated lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Epilepsy	Nervous system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0012 affected125 at risk
Migraine	Nervous system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Anxiety disorder	Psychiatric disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Pelvic haematoma	Reproductive system and breast disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Anastomotic haemorrhage	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk
Chronic allograft nephropathy	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Complication of transplanted kidney	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Graft dysfunction	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0006 affected127 at risk EG0016 affected125 at risk
Graft haemorrhage	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Graft ischaemia	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk
Nephropathy toxic	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Post procedural infection	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Renal haematoma	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Rib fracture	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Haematuria	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Postrenal failure	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Pyelocaliectasis	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk
Pyelonephritis chronic	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Renal failure	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk
Renal haematoma	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk
Renal impairment	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0009 affected127 at risk EG0019 affected125 at risk
Renal tubular disorder	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0002 affected127 at risk EG0011 affected125 at risk
Renal vein thrombosis	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0013 affected125 at risk
Ureteral necrosis	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0012 affected125 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0013 affected125 at risk
Urinoma	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Vesicoureteric reflux	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Bronchiolitis	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0002 affected127 at risk EG0011 affected125 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0002 affected127 at risk EG0012 affected125 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Cellulitis	Skin and subcutaneous tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Catheter removal	Surgical and medical procedures	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Transurethral prostatectomy	Surgical and medical procedures	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Anastomotic stenosis	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Aneurysm	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Aneurysm arteriovenous	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Arterial thrombosis	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Arteriosclerosis	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Arteritis	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Haematoma	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0003 affected127 at risk EG0010 affected125 at risk
Haemorrhagic cyst	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Hypertension	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Iliac artery stenosis	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Lymphocele	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0013 affected125 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk
Phlebitis	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0003 affected127 at risk EG0012 affected125 at risk
Post procedural haemorrhage	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0002 affected127 at risk EG0010 affected125 at risk
Venous thrombosis	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (9.0)	Non-systematic Assessment	EG00071 affected127 at risk EG00162 affected125 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (9.0)	Non-systematic Assessment	EG00042 affected127 at risk EG00123 affected125 at risk
Diarrheoa	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG00018 affected127 at risk EG0016 affected125 at risk
Oedema peripheral	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG00027 affected127 at risk EG00127 affected125 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG00015 affected127 at risk EG00114 affected125 at risk
Urinary tract infection	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG00028 affected127 at risk EG00131 affected125 at risk
Graft dysfunction	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG00022 affected127 at risk EG00110 affected125 at risk
Blood creatinine increased	Investigations	MedDRA (9.0)	Non-systematic Assessment	EG0007 affected127 at risk EG00112 affected125 at risk
Kidney transplant rejection	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0007 affected127 at risk EG0014 affected125 at risk
Dysuria	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0006 affected127 at risk EG0017 affected125 at risk
Hypertension	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG00018 affected127 at risk EG00122 affected125 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0004 affected127 at risk EG0017 affected125 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (9.0)	Non-systematic Assessment	EG00010 affected127 at risk EG00112 affected125 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0008 affected127 at risk EG0015 affected125 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0007 affected127 at risk EG0010 affected125 at risk
Gingival hypertrophy	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG00010 affected127 at risk EG0016 affected125 at risk
Pyrexia	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0008 affected127 at risk EG0017 affected125 at risk
Proteinuria	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0009 affected127 at risk EG0018 affected125 at risk
Bronchitis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0004 affected127 at risk EG0017 affected125 at risk
Herpes simplex	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0007 affected127 at risk EG0012 affected125 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG00013 affected127 at risk EG00117 affected125 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG00016 affected127 at risk EG00112 affected125 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0005 affected127 at risk EG0019 affected125 at risk
Overweight	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0007 affected127 at risk EG0015 affected125 at risk
Underweight	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0007 affected127 at risk EG0013 affected125 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0003 affected127 at risk EG0017 affected125 at risk

ID	Term
D009173	Mycophenolic Acid
D008775	Methylprednisolone
D008776	Methylprednisolone Hemisuccinate
D016572	Cyclosporine

Ancestor Terms

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005227	Fatty Acids
D008055	Lipids
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Facility	Status	City	State	ZIP	Country	Contacts
		Bordeaux		33076	France