lsting <-as_listing( out,key_cols =c("TRT01A", "LBTEST_U", "CPID"),disp_cols =names(out),main_title ="Listing of Laboratory Abnormalities Defined by Roche Safety Lab Standardization",main_footer ="Standard reference range, marked reference range and clinically relevant change from baseline are from the Roche Safety Lab Standardization guideline. Abnormalities are flagged as high (H) or low (L) if outside the standard reference range; high high (HH) or low low (LL) if outside the marked reference range with a clinically relevant change from baseline.")head(lsting, 20)
Listing of Laboratory Abnormalities Defined by Roche Safety Lab Standardization
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Clinically
Days Since % Change Standard Marked Relevant
Study Last Dose of from Reference Reference Change Abnormality
Treatment Lab Test (Unit) Center/Patient ID Day Study Drug Result Baseline Range Range Dec./Inc. Flag
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A: Drug X Alanine Aminotransferase Measurement (U/L) BRA-1/id-105 80 0 4.3 NA 5.5 - 31.1 7 - 55 40% / 40% LL
149 69 24.7 0.0 5.5 - 31.1 7 - 55 40% / 40%
314 165 24.9 0.7 5.5 - 31.1 7 - 55 40% / 40%
398 84 3.7 -85.2 5.5 - 31.1 7 - 55 40% / 40% LL
470 72 18.5 -24.9 5.5 - 31.1 7 - 55 40% / 40%
528 58 7.7 -68.7 5.5 - 31.1 7 - 55 40% / 40%
535 7 23.5 -4.8 5.5 - 31.1 7 - 55 40% / 40%
BRA-1/id-134 225 0 7.4 NA 5.5 - 31.1 7 - 55 40% / 40%
227 2 16.4 0.0 5.5 - 31.1 7 - 55 40% / 40%
255 28 11.2 -32.0 5.5 - 31.1 7 - 55 40% / 40%
269 14 15.9 -3.2 5.5 - 31.1 7 - 55 40% / 40%
357 88 24.4 48.3 5.5 - 31.1 7 - 55 40% / 40%
436 79 16.0 -2.4 5.5 - 31.1 7 - 55 40% / 40%
440 4 17.2 4.8 5.5 - 31.1 7 - 55 40% / 40%
BRA-1/id-42 176 0 16.6 NA 5.5 - 31.1 7 - 55 40% / 40%
477 301 16.5 0.0 5.5 - 31.1 7 - 55 40% / 40%
534 57 18.7 13.4 5.5 - 31.1 7 - 55 40% / 40%
550 16 11.4 -30.6 5.5 - 31.1 7 - 55 40% / 40%
569 19 21.7 31.3 5.5 - 31.1 7 - 55 40% / 40%
608 39 24.6 49.2 5.5 - 31.1 7 - 55 40% / 40%
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Standard reference range, marked reference range and clinically relevant change from baseline are from the Roche Safety Lab Standardization guideline. Abnormalities are flagged as high (H) or low (L) if outside the standard reference range; high high (HH) or low low (LL) if outside the marked reference range with a clinically relevant change from baseline.
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