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This rating is adjusted by using the cumulative and organ system specific adverse effect ratios which incorporates internal normalization in order to compare patients.
The intra-class correlations for adverse effect ratios exceeded the a priori designation as follows: 0.75 (CI: 0.55-0.87) for cumulative; 0.78 (CI: 0.60-0.88) for gastrointestinal; 0.81 (CI: 0.65-0.90) for CNS; and 0.84 (CI: 0.70-0.92) for aesthetic adverse effect ratios.
However, gastrointestinal, central nervous system (CNS), and aesthetic adverse effect ratios were generated a posteriori to further quantitate organ system specific adverse effects and interpatient differences of these manifestations were successfully demonstrated.
The adverse effect ratios documented that renal transplant recipients receiving tacrolimus and EC-MPS regimen had greater gastrointestinal and CNS adverse effects compared to patients stabilized on the cyclosporine and MMF regimen.
Adverse effect ratios (gastrointestinal, central nervous system [CNS], aesthetic and cumulative adverse effects) were compared between renal transplant recipients stabilized on either cyclosporine and MMF or tacrolimus and EC-MPS regimens since pre-established differences in adverse effect profiles have been reported [ 7, 19- 22].
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This cumulative adverse effect ratio represented the number of adverse effects with corresponding severity rating.
The cumulative adverse effect ratio was created a priori with incorporation of the normalization for purpose of interpatient comparison.
The cumulative adverse effect ratio was then calculated as the quotient of each patient's total score divided by the maximum score of all possible manifestations.
Patients treated with tacrolimus and EC-MPS experienced higher gastrointestinal adverse effect ratio (0.21 ± 0.15) compared to cyclosporine and MMF, (0.12 ± 0.11; P = 0.008).
Greater CNS adverse effect ratio was found in patients treated with tacrolimus and EC-MPS (0.26 ± 0.18) compared to cyclosporine and MMF (0.16 ± 0.17; P = 0.035).
The overall scoring system and each organ system adverse effect ratio achieved the a priori endpoint for intra-class correlation ≥ 0.7.
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