| Primary | Percentage of Participants With Acute Rejection | Diagnosis of acute rejection was suspected in any participant with an increase in serum creatinine greater than or equal to (≥) 25 percent (%). All suspected acute rejections were confirmed by biopsy. The start date of acute rejection was identified as the date of biopsy. | Intent-to-treat (ITT) population: all eligible participants who had at least baseline (BL) and 1 assessment of pharmacokinetics (PK) and pharmacodynamics (PD). Acute rejection was analyzed in any participant with an increase in serum creatinine of 25%. | Posted | | Number | | percentage of participants | | Day 1, Weeks 2, 4, 12, 24, and 28 | | | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Primary | Time to Rejection | The mean time, in days, from the date of enrollment to date of biopsy confirming acute rejection. | ITT population; only participants with acute or biopsy-proven rejection were included in the analysis. | Posted | | Mean | Standard Deviation | days | | Day 1, Weeks 2, 4, 12, 24, and 28 | | | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Percentage of Participants With Graft Loss | An allograft was presumed to be lost if a participant started dialysis and was not able to subsequently be removed from dialysis. | | Posted | | Number | | percentage of participants | | Day 1, Weeks 2, 4, 12, 24, and 28 | | | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Percentage of Participants Surviving | | | Posted | | Number | | percentage of participants | | Day 1, Weeks 2, 4, 12, 24, and 28 | | | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Total Mycophenolate Acid (MPA) by Visit and Timepoint | Drug quantification of total MPA (micrograms per milliliter [mcg/mL]) in the plasma was measured at time (T) = 0 minutes (min), 40 mins, and 120 mins. | ITT population; n=number of samples analyzed. | Posted | | Mean | Standard Deviation | mcg/mL | | Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up Visit), and any unscheduled visits | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Free MPA (mcg/mL) by Visit | Drug quantification of free MPA in the plasma was measured at T = 0, 40, and 120 mins. | ITT population; n=number of samples analyzed. | Posted | | Mean | Standard Deviation | mcg/mL | | Weeks 2, 4, 12, 24, safety follow-up (Week 28), and any unscheduled visits | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Primary | Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) | BPAR was defined according to 1997 Banff Criteria as a biopsy Banff grade of IA, IB, IIA, IIB, or III. Grade IA was defined as significant interstitial infiltration with greater than (>)25% of parenchyma affected, and foci of moderate tubulitis with >4 mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IB was defined as significant interstitial infiltration with >25% parenchyma affected, and foci of severe tubulitis with >10% mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IIA was defined as mild to moderate intimal arteritis. Grade IIB was defined as severe intimal arteritis comprising >25% of the luminal area. Grade III was defined as transmural arteritis and/or arterial fibrinoid changes and necrosis of medial smooth muscle cells. | | Posted | | Number | | percentage of participants | | Day 1, Weeks 2, 4, 12, 24, and 28 | | | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | MPA Area Under the Concentration - Time Curve From Time 0 to 12 Hours (AUC0-12) (mcg/mL) by Visit | The AUC0-12 of MPA was estimated on the validated limited sampling strategy, AUC (milligrams multiplied by height over liter [mg.h/L]) = 7.182 + 4.607 multiplied by (*) concentration at 0 minutes (C0)+ 0.998 * the concentration at 40 minutes (C0.67) + 2.149 * the concentration at 120 minutes (C2). | ITT population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mcg*hr/mL | | Predose and 40 minutes and 2 hours postdose at Weeks 2, 4, 12, and 24, and at the Safety follow-up (Week 28) | | | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Inosine MonoPhosphate DeHydrogenase (IMPDH) Activity by Visit and Timepoint | IMPDH activity in peripheral blood mononuclear cells (PBMCs) was measured at 2 timepoints per visit, 0 and 120 minutes and presented in enzyme units. The unit of measure of enzyme activity is "U". One U is defined as the amount of the enzyme that produces a certain amount of enzymatic activity that is, the amount that catalyzes the conversion of 1 micro mole of substrate per minute under pre-specified conditions (temperature, pH). | ITT population; n=number of samples analyzed. | Posted | | Mean | Standard Deviation | enzyme units | | BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | IMPDH Expression I by Visit and Timepoint | IMPDH I gene expression was measured by real time polymerase chain reaction (QRT-PCR) based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of messenger ribonucleic acid (mRNA) copies per cell (copies/cell). | ITT population; n=number of samples analyzed. | Posted | | Mean | Standard Deviation | number of mRNA copies/cell | | BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | IMPDH Expression II by Visit and Timepoint | IMPDH II gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell. | ITT population; n=number of samples analyzed. | Posted | | Mean | Standard Deviation | number of mRNA copies/cell | | BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Interleukin 8 (IL-8) Expression by Visit and Timepoint | IL-8 gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell. | ITT population; n=number of samples analyzed. | Posted | | Mean | Standard Deviation | number of mRNA copies/cell | | BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Tumor Necrosis Factor (TNF) Expression by Visit and Timepoint | TNF gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell. | ITT population; n=number of samples analyzed. | Posted | | Mean | Standard Deviation | number of mRNA copies/cell | | BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Percentage of Participants With Infection | Infections were graded according to the World Health Organization (WHO) worst grade observed. | Safety population: all enrolled participants | Posted | | Number | | percentage of participants | | BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up) | | | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Percentage of Participants With Gastrointestinal Toxicities | Gastrointestinal adverse events (AEs) according to WHO worst grade observed. | | Posted | | Number | | percentage of participants | | BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-up Visit) | | | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Percentage of Participants With Hematologic Toxicity | Hematological toxicities graded according to WHO worst grade observed (Grade 1=mild, Grade 2=moderate). | | Posted | | Number | | percentage of participants | | BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up) | | | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Spearman's Rank Correlation Coefficient Between MPA Levels and IMPDH Activity | The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | ITT population; n=number of samples analyzed. | Posted | | Number | | correlation coefficient | | BL and Weeks 2, 4, 12, and 24 | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Spearman's Rank Correlation Coefficient Between IMPDH I Expression and MPA Levels | The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | ITT population; n=number of samples analyzed | Posted | | Number | | correlation coefficient | | BL and Weeks 2, 4, 12, and 24 | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Spearman's Rank Correlation Coefficient Between IMPDH I Expression and Free Fraction | The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | ITT population; n=number of samples analyzed. | Posted | | Number | | correlation coefficient | | BL and Weeks 2, 4, 12, and 24 | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Spearman's Rank Correlation Coefficient Between IMPDH II Expression and MPA Levels | The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | ITT population; n=number of samples analyzed. | Posted | | Number | | correlation coefficient | | BL and Weeks 2, 4, 12, and 24 | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Spearman's Rank Correlation Coefficient Between IMPDH II Expression and Free Fraction | The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | ITT population; n=number of samples analyzed. | Posted | | Number | | correlation coefficient | | BL and Weeks 2, 4, 12, and 24 | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Spearman's Rank Correlation Coefficient Between IMPDH Inhibition and Risk of Acute Rejection | The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | ITT population; n=number of samples analyzed. | Posted | | Number | | correlation coefficient | | BL and Weeks 2, 4, 12, and 24 | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Infection | The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | ITT population; n=number of samples analyzed. | Posted | | Number | | correlation coefficient | | BL and Weeks 2, 4, 12, and 24 | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Hematologic Toxicity | The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | | Posted | | Number | | correlation coefficient | | BL and Weeks 2, 4, 12, and 24 | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Gastrointestinal Toxicity | The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | | Posted | | Number | | correlation coefficient | | BL and Weeks 2, 4, 12, and 24 | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Infection | The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | ITT population; n=number of samples | Posted | | Number | | correlation coefficient | | BL and Weeks 2, 4, 12, and 24 | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Hematologic Toxicity | The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | ITT population; n=number of samples | Posted | | Number | | correlation coefficient | | BL and Weeks 2, 4, 12, and 24 | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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| Secondary | Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Gastrointestinal Toxicity | The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | ITT population; n=number of samples | Posted | | Number | | correlation coefficient | | BL and Weeks 2, 4, 12, and 24 | Samples | Participants | | ID | Title | Description |
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| OG000 | MMF Monotherapy | Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
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