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German Speaking CDISC User Network CDISC European Interchange 22 April, 2008 1 [email protected]

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German Speaking CDISC User Network. CDISC European Interchange 22 April, 2008. [email protected]. Framework. CRF. Raw Data. Analysis Ready Data. Results. Protocol / Statistical Analysis Plan. Example of how SDTM, define.xml and ADaM fit together. - PowerPoint PPT Presentation

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Page 1: German Speaking CDISC User Network

German Speaking CDISC User Network

CDISC European Interchange

22 April, 2008

1

[email protected]

Page 2: German Speaking CDISC User Network

2

Framework

USUBJID CENTER TRTPN TRTC LBSTRESNLBSTNRLOLBSTNRHITBilAbnF LBSTRESl LBTMSHI LABTESTCD767 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL973 108 1 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL806 108 1 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL287 102 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL781 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL767 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL158 101 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL792 108 1 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL356 102 5 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL196 101 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL777 108 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL341 102 5 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL152 101 4 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL211 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL706 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL389 108 2 StdyDrg 1 0.1 1.2 0 0 0.833333 TBL159 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL

1063 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL805 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL226 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL

1099 108 1 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL389 108 2 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL183 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL741 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL356 102 5 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL253 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL214 101 4 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL777 108 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL214 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL831 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL225 101 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL225 101 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL387 108 2 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL335 102 5 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL173 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL806 108 1 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL777 108 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL973 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL234 101 4 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL183 101 4 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL763 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL170 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL158 101 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL335 102 5 StdyDrg 0.9 0.1 1.2 0 -0.105361 0.75 TBL141 101 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL788 108 1 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL

1120 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL331 102 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL272 101 4 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL973 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL370 102 5 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL335 102 5 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL266 101 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL382 102 5 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL390 108 2 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL973 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL221 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL85 101 3 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL

1096 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL61 101 3 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL

831 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL806 108 1 StdyDrg 1 0.1 1.2 0 0 0.833333 TBL108 101 3 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL718 108 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL185 101 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL733 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL

1065 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL234 101 4 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL266 101 0 PCB 0.5 0.1 1.2 0 -0.693147 0.416667 TBL337 102 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL389 108 2 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL

1086 108 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL788 108 1 StdyDrg 0.9 0.1 1.2 0 -0.105361 0.75 TBL389 108 2 StdyDrg 0.9 0.1 1.2 0 -0.105361 0.75 TBL819 108 1 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL60 101 0 PCB 0.4 0.1 1.2 0 -0.916291 0.333333 TBL

180 101 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL226 101 4 StdyDrg 0.4 0.1 1.2 0 -0.916291 0.333333 TBL830 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL287 102 0 PCB 0.5 0.1 1.2 0 -0.693147 0.416667 TBL312 102 0 PCB 0.5 0.1 1.2 0 -0.693147 0.416667 TBL921 108 0 PCB 0.5 0.1 1.2 0 -0.693147 0.416667 TBL392 108 2 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL745 108 1 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL382 102 5 StdyDrg 0.9 0.1 1.2 0 -0.105361 0.75 TBL781 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL973 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL780 108 1 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL

1049 108 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL266 101 0 PCB 0.5 0.1 1.2 0 -0.693147 0.416667 TBL190 101 4 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL312 102 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL788 108 1 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL

1086 108 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL338 102 5 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL50 101 3 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL

841 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL342 102 0 PCB 0.8 0.1 1.2 0 -0.223144 0.666667 TBL234 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL387 108 2 StdyDrg 1 0.1 1.2 0 0 0.833333 TBL723 108 0 PCB 0.9 0.1 1.2 0 -0.105361 0.75 TBL803 108 1 StdyDrg 1 0.1 1.2 0 0 0.833333 TBL338 102 5 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL

1081 108 1 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL755 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL50 101 3 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL

AE, DE, LBAE, DE, LB

LAB SEX LBDY Age USUBJID CENTER DRGGRPXPATFLAG PROJNUMTPrt TPrtNRLO TPrtNRHI TPrtAbnF Albm AlbmNRLOAlbmNRHI AblmAbnF TBil TbilNRLO TbilNRHI TBilAbnF Ast ASTNRLO ASTNRHI AstAbnF Alt ALTNRLO ALTNRHI AltAbnF AlkP AlkPNRLO AlkPNRHI AlkPAbnF LTbili TBL / ULN LAst AST / ULN LAlt ALT / ULN AT / ULN LAlkph ALP / ULN5 2 1 74 767 108 1 0 30 7.3 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 17 5 35 0 10 7 56 0 81 40 125 0 -0.510826 0.5 2.833213 0.485714 2.302585 0.178571 0.485714 4.394449 0.648

132 2 71 71 973 108 1 0 30 7.3 6 8.5 0 4.4 3.3 5.2 0 0.7 0.1 1.2 0 14 5 35 0 9 7 56 0 69 40 125 0 -0.356675 0.583333 2.639057 0.4 2.197225 0.160714 0.4 4.234107 0.5525 1 0 24 806 108 1 0 30 7.5 6 8.5 0 4.7 3.3 5.2 0 0.7 0.1 1.2 0 20 5 35 0 16 7 56 0 82 40 125 0 -0.356675 0.583333 2.995732 0.571429 2.772589 0.285714 0.571429 4.406719 0.6561 1 -1 26 287 102 0 0 27 7.2 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 25 5 35 0 29 7 56 0 63 40 125 0 -0.510826 0.5 3.218876 0.714286 3.367296 0.517857 0.714286 4.143135 0.5045 1 20 26 781 108 1 0 30 7.4 6 8.5 0 4.7 3.3 5.2 0 0.6 0.1 1.2 0 20 5 35 0 19 7 56 0 79 40 125 0 -0.510826 0.5 2.995732 0.571429 2.944439 0.339286 0.571429 4.369448 0.6325 2 -12 74 767 108 1 0 30 7.6 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 17 5 35 0 11 7 56 0 87 40 125 0 -0.510826 0.5 2.833213 0.485714 2.397895 0.196429 0.485714 4.465908 0.6962 1 0 20 158 101 0 0 127 7.2 6 8.5 0 4.4 3.3 5.2 0 0.6 0.1 1.2 0 19 5 35 0 18 7 56 0 77 40 125 0 -0.510826 0.5 2.944439 0.542857 2.890372 0.321429 0.542857 4.343805 0.6165 1 15 24 792 108 1 0 30 7.5 6 8.5 0 4.6 3.3 5.2 0 0.7 0.1 1.2 0 17 5 35 0 14 7 56 0 78 40 125 0 -0.356675 0.583333 2.833213 0.485714 2.639057 0.25 0.485714 4.356709 0.6241 1 0 27 356 102 5 0 27 7.1 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 22 5 35 0 25 7 56 0 55 40 125 0 -0.693147 0.416667 3.091042 0.628571 3.218876 0.446429 0.628571 4.007333 0.442 1 -14 19 196 101 0 0 127 7.3 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 26 5 35 0 26 7 56 0 71 40 125 0 -0.510826 0.5 3.258097 0.742857 3.258097 0.464286 0.742857 4.26268 0.5685 2 1 71 777 108 0 0 30 7.6 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 17 5 35 0 13 7 56 0 74 40 125 0 -0.510826 0.5 2.833213 0.485714 2.564949 0.232143 0.485714 4.304065 0.5921 1 15 30 341 102 5 0 27 7 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 20 5 35 0 21 7 56 0 56 40 125 0 -0.693147 0.416667 2.995732 0.571429 3.044522 0.375 0.571429 4.025352 0.4482 1 2 27 152 101 4 0 127 7.3 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 23 5 35 0 24 7 56 0 82 40 125 0 -0.510826 0.5 3.135494 0.657143 3.178054 0.428571 0.657143 4.406719 0.6561 1 1 21 211 101 4 0 127 7.4 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 22 5 35 0 17 7 56 0 82 40 125 0 -0.693147 0.416667 3.091042 0.628571 2.833213 0.303571 0.628571 4.406719 0.6565 1 -12 37 706 108 1 0 30 7 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 18 5 35 0 12 7 56 0 72 40 125 0 -0.510826 0.5 2.890372 0.514286 2.484907 0.214286 0.514286 4.276666 0.5764 1 15 25 389 108 2 0 35 7.5 6 8.5 0 4.9 3.3 5.2 0 1 0.1 1.2 0 21 5 35 0 16 7 56 0 64 40 125 0 0 0.833333 3.044522 0.6 2.772589 0.285714 0.6 4.158883 0.5122 1 2 19 159 101 4 0 127 7.6 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 23 5 35 0 19 7 56 0 71 40 125 0 -0.693147 0.416667 3.135494 0.657143 2.944439 0.339286 0.657143 4.26268 0.568

132 2 120 70 1063 108 1 0 30 7.3 6 8.5 0 4.2 3.3 5.2 0 0.6 0.1 1.2 0 16 5 35 0 12 7 56 0 65 40 125 0 -0.510826 0.5 2.772589 0.457143 2.484907 0.214286 0.457143 4.174387 0.525 1 0 28 805 108 1 0 30 7.6 6 8.5 0 4.7 3.3 5.2 0 0.6 0.1 1.2 0 20 5 35 0 13 7 56 0 73 40 125 0 -0.510826 0.5 2.995732 0.571429 2.564949 0.232143 0.571429 4.290459 0.5841 1 20 43 226 101 4 0 127 7.5 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 24 5 35 0 22 7 56 0 61 40 125 0 -0.693147 0.416667 3.178054 0.685714 3.091042 0.392857 0.685714 4.110874 0.488

132 2 36 86 1099 108 1 0 30 7.6 6 8.5 0 4.5 3.3 5.2 0 0.8 0.1 1.2 0 16 5 35 0 14 7 56 0 66 40 125 0 -0.223144 0.666667 2.772589 0.457143 2.639057 0.25 0.457143 4.189655 0.5284 1 12 25 389 108 2 0 35 7.4 6 8.5 0 4.7 3.3 5.2 0 0.8 0.1 1.2 0 20 5 35 0 13 7 56 0 65 40 125 0 -0.223144 0.666667 2.995732 0.571429 2.564949 0.232143 0.571429 4.174387 0.522 1 2 27 183 101 4 0 127 7.4 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 21 5 35 0 23 7 56 0 78 40 125 0 -0.693147 0.416667 3.044522 0.6 3.135494 0.410714 0.6 4.356709 0.6245 1 10 30 741 108 1 0 30 7.7 6 8.5 0 4.8 3.3 5.2 0 0.6 0.1 1.2 0 18 5 35 0 17 7 56 0 82 40 125 0 -0.510826 0.5 2.890372 0.514286 2.833213 0.303571 0.514286 4.406719 0.6561 1 3 27 356 102 5 0 27 7.1 6 8.5 0 4.6 3.3 5.2 0 0.7 0.1 1.2 0 18 5 35 0 20 7 56 0 49 40 125 0 -0.356675 0.583333 2.890372 0.514286 2.995732 0.357143 0.514286 3.89182 0.3922 1 13 21 253 101 4 0 127 7.2 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 21 5 35 0 25 7 56 0 71 40 125 0 -0.693147 0.416667 3.044522 0.6 3.218876 0.446429 0.6 4.26268 0.5681 1 13 23 214 101 4 0 127 7.3 6 8.5 0 4.5 3.3 5.2 0 0.6 0.1 1.2 0 19 5 35 0 18 7 56 0 64 40 125 0 -0.510826 0.5 2.944439 0.542857 2.890372 0.321429 0.542857 4.158883 0.5125 2 15 71 777 108 0 0 30 7.2 6 8.5 0 4.5 3.3 5.2 0 0.7 0.1 1.2 0 13 5 35 0 8 7 56 0 73 40 125 0 -0.356675 0.583333 2.564949 0.371429 2.079442 0.142857 0.371429 4.290459 0.5841 1 23 23 214 101 4 0 127 7.4 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 19 5 35 0 17 7 56 0 67 40 125 0 -0.693147 0.416667 2.944439 0.542857 2.833213 0.303571 0.542857 4.204693 0.5365 2 22 81 831 108 1 0 30 7.2 6 8.5 0 4.3 3.3 5.2 0 0.5 0.1 1.2 0 15 5 35 0 9 7 56 0 80 40 125 0 -0.693147 0.416667 2.70805 0.428571 2.197225 0.160714 0.428571 4.382027 0.641 1 -13 25 225 101 0 0 127 7.2 6 8.5 0 4.3 3.3 5.2 0 0.6 0.1 1.2 0 24 5 35 0 19 7 56 0 64 40 125 0 -0.510826 0.5 3.178054 0.685714 2.944439 0.339286 0.685714 4.158883 0.5121 1 -11 25 225 101 0 0 127 7.2 6 8.5 0 4.3 3.3 5.2 0 0.6 0.1 1.2 0 24 5 35 0 19 7 56 0 64 40 125 0 -0.510826 0.5 3.178054 0.685714 2.944439 0.339286 0.685714 4.158883 0.5124 1 7 39 387 108 2 0 35 7.6 6 8.5 0 5 3.3 5.2 0 0.8 0.1 1.2 0 24 5 35 0 19 7 56 0 52 40 125 0 -0.223144 0.666667 3.178054 0.685714 2.944439 0.339286 0.685714 3.951244 0.4161 1 25 25 335 102 5 0 27 6.9 6 8.5 0 4.5 3.3 5.2 0 0.8 0.1 1.2 0 25 5 35 0 21 7 56 0 59 40 125 0 -0.223144 0.666667 3.218876 0.714286 3.044522 0.375 0.714286 4.077537 0.4722 1 -15 22 173 101 4 0 127 7.3 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 18 5 35 0 17 7 56 0 80 40 125 0 -0.693147 0.416667 2.890372 0.514286 2.833213 0.303571 0.514286 4.382027 0.645 1 7 24 806 108 1 0 30 7.2 6 8.5 0 4.6 3.3 5.2 0 0.8 0.1 1.2 0 20 5 35 0 16 7 56 0 67 40 125 0 -0.223144 0.666667 2.995732 0.571429 2.772589 0.285714 0.571429 4.204693 0.5365 2 -4 71 777 108 0 0 30 7 6 8.5 0 4.4 3.3 5.2 0 0.6 0.1 1.2 0 19 5 35 0 11 7 56 0 72 40 125 0 -0.510826 0.5 2.944439 0.542857 2.397895 0.196429 0.542857 4.276666 0.576

132 2 78 71 973 108 1 0 30 7.5 6 8.5 0 4.3 3.3 5.2 0 0.5 0.1 1.2 0 17 5 35 0 12 7 56 0 75 40 125 0 -0.693147 0.416667 2.833213 0.485714 2.484907 0.214286 0.485714 4.317488 0.61 1 -8 29 234 101 4 0 127 7.1 6 8.5 0 4.4 3.3 5.2 0 0.6 0.1 1.2 0 23 5 35 0 15 7 56 0 82 40 125 0 -0.510826 0.5 3.135494 0.657143 2.70805 0.267857 0.657143 4.406719 0.6562 1 6 27 183 101 4 0 127 7.3 6 8.5 0 4.5 3.3 5.2 0 0.7 0.1 1.2 0 22 5 35 0 25 7 56 0 81 40 125 0 -0.356675 0.583333 3.091042 0.628571 3.218876 0.446429 0.628571 4.394449 0.6485 1 -4 75 763 108 1 0 30 7.4 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 20 5 35 0 13 7 56 0 64 40 125 0 -0.510826 0.5 2.995732 0.571429 2.564949 0.232143 0.571429 4.158883 0.5122 1 0 25 170 101 4 0 127 7.3 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 24 5 35 0 29 7 56 0 67 40 125 0 -0.693147 0.416667 3.178054 0.685714 3.367296 0.517857 0.685714 4.204693 0.5362 1 1 20 158 101 0 0 127 7.3 6 8.5 0 4.5 3.3 5.2 0 0.6 0.1 1.2 0 18 5 35 0 14 7 56 0 81 40 125 0 -0.510826 0.5 2.890372 0.514286 2.639057 0.25 0.514286 4.394449 0.6481 1 7 25 335 102 5 0 27 6.9 6 8.5 0 4.5 3.3 5.2 0 0.9 0.1 1.2 0 25 5 35 0 25 7 56 0 60 40 125 0 -0.105361 0.75 3.218876 0.714286 3.218876 0.446429 0.714286 4.094345 0.482 1 0 19 141 101 0 0 127 7.6 6 8.5 0 4.7 3.3 5.2 0 0.7 0.1 1.2 0 20 5 35 0 17 7 56 0 83 40 125 0 -0.356675 0.583333 2.995732 0.571429 2.833213 0.303571 0.571429 4.418841 0.6645 1 20 20 788 108 1 0 30 7.3 6 8.5 0 4.7 3.3 5.2 0 0.7 0.1 1.2 0 23 5 35 0 15 7 56 0 78 40 125 0 -0.356675 0.583333 3.135494 0.657143 2.70805 0.267857 0.657143 4.356709 0.624

132 2 44 73 1120 108 1 0 30 7.3 6 8.5 0 4.2 3.3 5.2 0 0.5 0.1 1.2 0 16 5 35 0 10 7 56 0 61 40 125 0 -0.693147 0.416667 2.772589 0.457143 2.302585 0.178571 0.457143 4.110874 0.4881 1 2 24 331 102 0 0 27 7.5 6 8.5 0 4.8 3.3 5.2 0 0.7 0.1 1.2 0 19 5 35 0 20 7 56 0 67 40 125 0 -0.356675 0.583333 2.944439 0.542857 2.995732 0.357143 0.542857 4.204693 0.5362 1 0 36 272 101 4 0 127 7.4 6 8.5 0 4.5 3.3 5.2 0 0.7 0.1 1.2 0 19 5 35 0 13 7 56 0 73 40 125 0 -0.356675 0.583333 2.944439 0.542857 2.564949 0.232143 0.542857 4.290459 0.584

132 2 57 71 973 108 1 0 30 7.2 6 8.5 0 4.3 3.3 5.2 0 0.6 0.1 1.2 0 18 5 35 0 9 7 56 0 66 40 125 0 -0.510826 0.5 2.890372 0.514286 2.197225 0.160714 0.514286 4.189655 0.5281 1 0 24 370 102 5 0 27 7.3 6 8.5 0 4.6 3.3 5.2 0 0.7 0.1 1.2 0 26 5 35 0 35 7 56 0 62 40 125 0 -0.356675 0.583333 3.258097 0.742857 3.555348 0.625 0.742857 4.127134 0.4961 1 20 25 335 102 5 0 27 6.7 6 8.5 0 4.4 3.3 5.2 0 0.7 0.1 1.2 0 24 5 35 0 28 7 56 0 58 40 125 0 -0.356675 0.583333 3.178054 0.685714 3.332205 0.5 0.685714 4.060443 0.4642 1 6 30 266 101 0 0 127 7.2 6 8.5 0 4.3 3.3 5.2 0 0.7 0.1 1.2 0 24 5 35 0 20 7 56 0 72 40 125 0 -0.356675 0.583333 3.178054 0.685714 2.995732 0.357143 0.685714 4.276666 0.5761 1 12 33 382 102 5 0 27 6.9 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 25 5 35 0 34 7 56 0 61 40 125 0 -0.510826 0.5 3.218876 0.714286 3.526361 0.607143 0.714286 4.110874 0.4884 1 2 37 390 108 2 0 35 7.4 6 8.5 0 4.7 3.3 5.2 0 0.6 0.1 1.2 0 30 5 35 0 18 7 56 0 64 40 125 0 -0.510826 0.5 3.401197 0.857143 2.890372 0.321429 0.857143 4.158883 0.512

132 2 64 71 973 108 1 0 30 7 6 8.5 0 4.2 3.3 5.2 0 0.6 0.1 1.2 0 16 5 35 0 9 7 56 0 65 40 125 0 -0.510826 0.5 2.772589 0.457143 2.197225 0.160714 0.457143 4.174387 0.521 1 13 21 221 101 4 0 127 7.5 6 8.5 0 4.4 3.3 5.2 0 0.5 0.1 1.2 0 22 5 35 0 17 7 56 0 66 40 125 0 -0.693147 0.416667 3.091042 0.628571 2.833213 0.303571 0.628571 4.189655 0.5281 1 -11 33 85 101 3 0 23 7.4 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 30 5 35 0 22 7 56 0 83 40 125 0 -0.693147 0.416667 3.401197 0.857143 3.091042 0.392857 0.857143 4.418841 0.664

132 2 127 59 1096 108 1 0 30 7.4 6 8.5 0 4.2 3.3 5.2 0 0.5 0.1 1.2 0 17 5 35 0 12 7 56 0 66 40 125 0 -0.693147 0.416667 2.833213 0.485714 2.484907 0.214286 0.485714 4.189655 0.5281 1 1 21 61 101 3 0 23 7.1 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 25 5 35 0 23 7 56 0 84 40 125 0 -0.693147 0.416667 3.218876 0.714286 3.135494 0.410714 0.714286 4.430817 0.6725 2 25 81 831 108 1 0 30 7.3 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 12 5 35 0 9 7 56 0 83 40 125 0 -0.693147 0.416667 2.484907 0.342857 2.197225 0.160714 0.342857 4.418841 0.6645 1 18 24 806 108 1 0 30 7.4 6 8.5 0 4.8 3.3 5.2 0 1 0.1 1.2 0 19 5 35 0 14 7 56 0 71 40 125 0 0 0.833333 2.944439 0.542857 2.639057 0.25 0.542857 4.26268 0.5681 1 2 22 108 101 3 0 23 7.5 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 23 5 35 0 22 7 56 0 83 40 125 0 -0.693147 0.416667 3.135494 0.657143 3.091042 0.392857 0.657143 4.418841 0.6645 1 -17 27 718 108 0 0 30 7.5 6 8.5 0 4.7 3.3 5.2 0 0.6 0.1 1.2 0 23 5 35 0 17 7 56 0 68 40 125 0 -0.510826 0.5 3.135494 0.657143 2.833213 0.303571 0.657143 4.219508 0.5442 1 6 28 185 101 0 0 127 7 6 8.5 0 4.5 3.3 5.2 0 0.7 0.1 1.2 0 18 5 35 0 19 7 56 0 67 40 125 0 -0.356675 0.583333 2.890372 0.514286 2.944439 0.339286 0.514286 4.204693 0.5365 1 1 22 733 108 1 0 30 7.2 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 19 5 35 0 11 7 56 0 91 40 125 0 -0.510826 0.5 2.944439 0.542857 2.397895 0.196429 0.542857 4.51086 0.728

132 2 -14 79 1065 108 1 0 30 7 6 8.5 0 4.3 3.3 5.2 0 0.5 0.1 1.2 0 15 5 35 0 12 7 56 0 58 40 125 0 -0.693147 0.416667 2.70805 0.428571 2.484907 0.214286 0.428571 4.060443 0.4641 1 23 29 234 101 4 0 127 7.1 6 8.5 0 4.5 3.3 5.2 0 0.7 0.1 1.2 0 19 5 35 0 18 7 56 0 64 40 125 0 -0.356675 0.583333 2.944439 0.542857 2.890372 0.321429 0.542857 4.158883 0.5122 1 -10 30 266 101 0 0 127 7.3 6 8.5 0 4.4 3.3 5.2 0 0.5 0.1 1.2 0 23 5 35 0 17 7 56 0 84 40 125 0 -0.693147 0.416667 3.135494 0.657143 2.833213 0.303571 0.657143 4.430817 0.6721 1 15 29 337 102 0 0 27 6.9 6 8.5 0 4.7 3.3 5.2 0 0.7 0.1 1.2 0 21 5 35 0 24 7 56 0 76 40 125 0 -0.356675 0.583333 3.044522 0.6 3.178054 0.428571 0.6 4.330733 0.6084 1 4 25 389 108 2 0 35 7 6 8.5 0 4.6 3.3 5.2 0 0.7 0.1 1.2 0 22 5 35 0 18 7 56 0 60 40 125 0 -0.356675 0.583333 3.091042 0.628571 2.890372 0.321429 0.628571 4.094345 0.48

132 1 1 68 1086 108 0 0 30 7.3 6 8.5 0 4.4 3.3 5.2 0 0.6 0.1 1.2 0 14 5 35 0 12 7 56 0 65 40 125 0 -0.510826 0.5 2.639057 0.4 2.484907 0.214286 0.4 4.174387 0.525 1 18 20 788 108 1 0 30 7.4 6 8.5 0 4.8 3.3 5.2 0 0.9 0.1 1.2 0 15 5 35 0 14 7 56 0 77 40 125 0 -0.105361 0.75 2.70805 0.428571 2.639057 0.25 0.428571 4.343805 0.6164 1 2 25 389 108 2 0 35 7.5 6 8.5 0 5 3.3 5.2 0 0.9 0.1 1.2 0 27 5 35 0 24 7 56 0 61 40 125 0 -0.105361 0.75 3.295837 0.771429 3.178054 0.428571 0.771429 4.110874 0.4885 1 1 65 819 108 1 0 30 7.6 6 8.5 0 4.6 3.3 5.2 0 0.8 0.1 1.2 0 19 5 35 0 15 7 56 0 77 40 125 0 -0.223144 0.666667 2.944439 0.542857 2.70805 0.267857 0.542857 4.343805 0.6161 1 1 19 60 101 0 0 23 7.2 6 8.5 0 4.6 3.3 5.2 0 0.4 0.1 1.2 0 25 5 35 0 17 7 56 0 75 40 125 0 -0.916291 0.333333 3.218876 0.714286 2.833213 0.303571 0.714286 4.317488 0.62 1 6 29 180 101 0 0 127 7.3 6 8.5 0 4.4 3.3 5.2 0 0.6 0.1 1.2 0 27 5 35 0 28 7 56 0 58 40 125 0 -0.510826 0.5 3.295837 0.771429 3.332205 0.5 0.771429 4.060443 0.4641 1 -11 43 226 101 4 0 127 7.1 6 8.5 0 4.4 3.3 5.2 0 0.4 0.1 1.2 0 27 5 35 0 20 7 56 0 77 40 125 0 -0.916291 0.333333 3.295837 0.771429 2.995732 0.357143 0.771429 4.343805 0.6165 2 3 71 830 108 1 0 30 7 6 8.5 0 4.3 3.3 5.2 0 0.6 0.1 1.2 0 16 5 35 0 8 7 56 0 72 40 125 0 -0.510826 0.5 2.772589 0.457143 2.079442 0.142857 0.457143 4.276666 0.5761 1 -4 26 287 102 0 0 27 7.1 6 8.5 0 4.7 3.3 5.2 0 0.5 0.1 1.2 0 26 5 35 0 30 7 56 0 62 40 125 0 -0.693147 0.416667 3.258097 0.742857 3.401197 0.535714 0.742857 4.127134 0.4961 1 0 28 312 102 0 0 27 6.9 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 24 5 35 0 25 7 56 0 51 40 125 0 -0.693147 0.416667 3.178054 0.685714 3.218876 0.446429 0.685714 3.931826 0.408

132 2 -16 73 921 108 0 0 30 7.7 6 8.5 0 4.4 3.3 5.2 0 0.5 0.1 1.2 0 15 5 35 0 10 7 56 0 58 40 125 0 -0.693147 0.416667 2.70805 0.428571 2.302585 0.178571 0.428571 4.060443 0.4644 1 12 30 392 108 2 0 35 7.4 6 8.5 0 4.7 3.3 5.2 0 0.7 0.1 1.2 0 27 5 35 0 27 7 56 0 62 40 125 0 -0.356675 0.583333 3.295837 0.771429 3.295837 0.482143 0.771429 4.127134 0.4965 1 -5 20 745 108 1 0 30 7.6 6 8.5 0 4.9 3.3 5.2 0 0.7 0.1 1.2 0 15 5 35 0 13 7 56 0 94 40 125 0 -0.356675 0.583333 2.70805 0.428571 2.564949 0.232143 0.428571 4.543295 0.7521 1 5 33 382 102 5 0 27 6.9 6 8.5 0 4.6 3.3 5.2 0 0.9 0.1 1.2 0 22 5 35 0 17 7 56 0 58 40 125 0 -0.105361 0.75 3.091042 0.628571 2.833213 0.303571 0.628571 4.060443 0.4645 1 18 26 781 108 1 0 30 7.2 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 17 5 35 0 19 7 56 0 80 40 125 0 -0.510826 0.5 2.833213 0.485714 2.944439 0.339286 0.485714 4.382027 0.64

132 2 43 71 973 108 1 0 30 7.2 6 8.5 0 4.3 3.3 5.2 0 0.5 0.1 1.2 0 20 5 35 0 14 7 56 0 75 40 125 0 -0.693147 0.416667 2.995732 0.571429 2.639057 0.25 0.571429 4.317488 0.65 1 -6 25 780 108 1 0 30 7.7 6 8.5 0 4.8 3.3 5.2 0 0.7 0.1 1.2 0 20 5 35 0 17 7 56 0 96 40 125 0 -0.356675 0.583333 2.995732 0.571429 2.833213 0.303571 0.571429 4.564348 0.768

132 2 78 74 1049 108 0 0 30 7.4 6 8.5 0 4.2 3.3 5.2 0 0.7 0.1 1.2 0 18 5 35 0 14 7 56 0 64 40 125 0 -0.356675 0.583333 2.890372 0.514286 2.639057 0.25 0.514286 4.158883 0.5122 1 22 30 266 101 0 0 127 7 6 8.5 0 4.3 3.3 5.2 0 0.5 0.1 1.2 0 25 5 35 0 26 7 56 0 73 40 125 0 -0.693147 0.416667 3.218876 0.714286 3.258097 0.464286 0.714286 4.290459 0.5842 1 0 19 190 101 4 0 127 7.6 6 8.5 0 4.5 3.3 5.2 0 0.6 0.1 1.2 0 22 5 35 0 25 7 56 0 81 40 125 0 -0.510826 0.5 3.091042 0.628571 3.218876 0.446429 0.628571 4.394449 0.6481 1 -1 28 312 102 0 0 27 7.2 6 8.5 0 4.8 3.3 5.2 0 0.6 0.1 1.2 0 19 5 35 0 25 7 56 0 54 40 125 0 -0.510826 0.5 2.944439 0.542857 3.218876 0.446429 0.542857 3.988984 0.4325 1 9 20 788 108 1 0 30 7.2 6 8.5 0 4.7 3.3 5.2 0 0.8 0.1 1.2 0 15 5 35 0 15 7 56 0 79 40 125 0 -0.223144 0.666667 2.70805 0.428571 2.70805 0.267857 0.428571 4.369448 0.632

132 1 44 68 1086 108 0 0 30 7.3 6 8.5 0 4.4 3.3 5.2 0 0.6 0.1 1.2 0 14 5 35 0 11 7 56 0 62 40 125 0 -0.510826 0.5 2.639057 0.4 2.397895 0.196429 0.4 4.127134 0.4961 1 7 20 338 102 5 0 27 7.1 6 8.5 0 4.6 3.3 5.2 0 0.7 0.1 1.2 0 23 5 35 0 17 7 56 0 75 40 125 0 -0.356675 0.583333 3.135494 0.657143 2.833213 0.303571 0.657143 4.317488 0.61 1 1 35 50 101 3 0 23 7.5 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 18 5 35 0 15 7 56 0 65 40 125 0 -0.693147 0.416667 2.890372 0.514286 2.70805 0.267857 0.514286 4.174387 0.52

132 2 1 73 841 108 1 0 30 7.2 6 8.5 0 4.2 3.3 5.2 0 0.5 0.1 1.2 0 15 5 35 0 9 7 56 0 76 40 125 0 -0.693147 0.416667 2.70805 0.428571 2.197225 0.160714 0.428571 4.330733 0.6081 1 20 21 342 102 0 0 27 6.7 6 8.5 0 4.5 3.3 5.2 0 0.8 0.1 1.2 0 23 5 35 0 25 7 56 0 50 40 125 0 -0.223144 0.666667 3.135494 0.657143 3.218876 0.446429 0.657143 3.912023 0.41 1 13 29 234 101 4 0 127 6.9 6 8.5 0 4.4 3.3 5.2 0 0.5 0.1 1.2 0 19 5 35 0 17 7 56 0 69 40 125 0 -0.693147 0.416667 2.944439 0.542857 2.833213 0.303571 0.542857 4.234107 0.5524 1 15 39 387 108 2 0 35 7.8 6 8.5 0 5.1 3.3 5.2 0 1 0.1 1.2 0 25 5 35 0 20 7 56 0 62 40 125 0 0 0.833333 3.218876 0.714286 2.995732 0.357143 0.714286 4.127134 0.4965 1 10 19 723 108 0 0 30 7.2 6 8.5 0 4.8 3.3 5.2 0 0.9 0.1 1.2 0 17 5 35 0 14 7 56 0 86 40 125 0 -0.105361 0.75 2.833213 0.485714 2.639057 0.25 0.485714 4.454347 0.688

CRF Raw Data Analysis Ready Data Results

Protocol / Statistical Analysis Plan

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Example of how SDTM, define.xml and ADaM fit together

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“It is perfectly true, as philosophers say, that life must be understood backwards. But they forget the other proposition, that it must be lived forwards.”

Søren Kierkegaard

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Starting with the output and working backwards

Two questions could occur to us:• How is “Time to Event” Calculated• What is a “Dermatological Event”

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The Figure 14.1 is Listed in the Analysis Results Level Metadata

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From the Analysis Level Metadata we can get to the SAP and the Supporting Dataset ADTTE

The Analysis Results Level Metadata links to a written description of “Time to Event” and “Dermatological Event” appears in the SAP

The Analysis Results Level Metadata also links to the Analysis Dataset Level Metadata

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Use of Dataset and Variable Level Metadata

Analysis Dataset Level Metadata has the Analysis Variable Level Metadata and links to the computational method for “Time to event” COMP_ADTTE_TTP

…and also links to the source dataset, ADAE

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Use of Dataset and Variable Level Metadata

The ADAE Analysis Dataset Level Metadata has the Analysis Variable Level Metadata for “Dermatological Event,” AEDERMFN and links to the appropriate computational method, COMP_ADAE_AEDERMFN

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Use of Dataset and Variable Level Metadata to the CRF

From “AEDECOD” we can go to the SDTM AE and its Variable Level Metadata

AEDECOD Variable Level Metadata links to the Annotated CRF

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“It is perfectly true, as philosophers say, that life must be understood backwards. But they forget the other proposition,

that it must be lived forwards.”

Søren Kierkegaard

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SAP – Define the Analysis / Output

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Specify the output

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Specify the Source Data

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Specify required variables and their calculation method

Dermatological Event

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Specify required variables and their calculation method

Time to Event

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An Extra Step: Specify the Formal Expression for the Calculation Method

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An Extra Step: Specify the Formal Expression for the Calculation Method

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Using define.xml as an executable

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Generate the ADaM dataset

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Generating the Submission Output

Submission GraphicsSubmission Graphics

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Framework

USUBJID CENTER TRTPN TRTC LBSTRESNLBSTNRLOLBSTNRHITBilAbnF LBSTRESl LBTMSHI LABTESTCD767 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL973 108 1 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL806 108 1 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL287 102 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL781 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL767 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL158 101 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL792 108 1 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL356 102 5 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL196 101 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL777 108 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL341 102 5 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL152 101 4 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL211 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL706 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL389 108 2 StdyDrg 1 0.1 1.2 0 0 0.833333 TBL159 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL

1063 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL805 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL226 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL

1099 108 1 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL389 108 2 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL183 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL741 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL356 102 5 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL253 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL214 101 4 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL777 108 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL214 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL831 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL225 101 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL225 101 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL387 108 2 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL335 102 5 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL173 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL806 108 1 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL777 108 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL973 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL234 101 4 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL183 101 4 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL763 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL170 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL158 101 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL335 102 5 StdyDrg 0.9 0.1 1.2 0 -0.105361 0.75 TBL141 101 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL788 108 1 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL

1120 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL331 102 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL272 101 4 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL973 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL370 102 5 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL335 102 5 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL266 101 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL382 102 5 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL390 108 2 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL973 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL221 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL85 101 3 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL

1096 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL61 101 3 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL

831 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL806 108 1 StdyDrg 1 0.1 1.2 0 0 0.833333 TBL108 101 3 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL718 108 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL185 101 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL733 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL

1065 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL234 101 4 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL266 101 0 PCB 0.5 0.1 1.2 0 -0.693147 0.416667 TBL337 102 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL389 108 2 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL

1086 108 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL788 108 1 StdyDrg 0.9 0.1 1.2 0 -0.105361 0.75 TBL389 108 2 StdyDrg 0.9 0.1 1.2 0 -0.105361 0.75 TBL819 108 1 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL60 101 0 PCB 0.4 0.1 1.2 0 -0.916291 0.333333 TBL

180 101 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL226 101 4 StdyDrg 0.4 0.1 1.2 0 -0.916291 0.333333 TBL830 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL287 102 0 PCB 0.5 0.1 1.2 0 -0.693147 0.416667 TBL312 102 0 PCB 0.5 0.1 1.2 0 -0.693147 0.416667 TBL921 108 0 PCB 0.5 0.1 1.2 0 -0.693147 0.416667 TBL392 108 2 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL745 108 1 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL382 102 5 StdyDrg 0.9 0.1 1.2 0 -0.105361 0.75 TBL781 108 1 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL973 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL780 108 1 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL

1049 108 0 PCB 0.7 0.1 1.2 0 -0.356675 0.583333 TBL266 101 0 PCB 0.5 0.1 1.2 0 -0.693147 0.416667 TBL190 101 4 StdyDrg 0.6 0.1 1.2 0 -0.510826 0.5 TBL312 102 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL788 108 1 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL

1086 108 0 PCB 0.6 0.1 1.2 0 -0.510826 0.5 TBL338 102 5 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL50 101 3 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL

841 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL342 102 0 PCB 0.8 0.1 1.2 0 -0.223144 0.666667 TBL234 101 4 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL387 108 2 StdyDrg 1 0.1 1.2 0 0 0.833333 TBL723 108 0 PCB 0.9 0.1 1.2 0 -0.105361 0.75 TBL803 108 1 StdyDrg 1 0.1 1.2 0 0 0.833333 TBL338 102 5 StdyDrg 0.7 0.1 1.2 0 -0.356675 0.583333 TBL

1081 108 1 StdyDrg 0.8 0.1 1.2 0 -0.223144 0.666667 TBL755 108 1 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL50 101 3 StdyDrg 0.5 0.1 1.2 0 -0.693147 0.416667 TBL

AE, DE, LBAE, DE, LB

LAB SEX LBDY Age USUBJID CENTER DRGGRPXPATFLAG PROJNUMTPrt TPrtNRLO TPrtNRHI TPrtAbnF Albm AlbmNRLOAlbmNRHI AblmAbnF TBil TbilNRLO TbilNRHI TBilAbnF Ast ASTNRLO ASTNRHI AstAbnF Alt ALTNRLO ALTNRHI AltAbnF AlkP AlkPNRLO AlkPNRHI AlkPAbnF LTbili TBL / ULN LAst AST / ULN LAlt ALT / ULN AT / ULN LAlkph ALP / ULN5 2 1 74 767 108 1 0 30 7.3 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 17 5 35 0 10 7 56 0 81 40 125 0 -0.510826 0.5 2.833213 0.485714 2.302585 0.178571 0.485714 4.394449 0.648

132 2 71 71 973 108 1 0 30 7.3 6 8.5 0 4.4 3.3 5.2 0 0.7 0.1 1.2 0 14 5 35 0 9 7 56 0 69 40 125 0 -0.356675 0.583333 2.639057 0.4 2.197225 0.160714 0.4 4.234107 0.5525 1 0 24 806 108 1 0 30 7.5 6 8.5 0 4.7 3.3 5.2 0 0.7 0.1 1.2 0 20 5 35 0 16 7 56 0 82 40 125 0 -0.356675 0.583333 2.995732 0.571429 2.772589 0.285714 0.571429 4.406719 0.6561 1 -1 26 287 102 0 0 27 7.2 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 25 5 35 0 29 7 56 0 63 40 125 0 -0.510826 0.5 3.218876 0.714286 3.367296 0.517857 0.714286 4.143135 0.5045 1 20 26 781 108 1 0 30 7.4 6 8.5 0 4.7 3.3 5.2 0 0.6 0.1 1.2 0 20 5 35 0 19 7 56 0 79 40 125 0 -0.510826 0.5 2.995732 0.571429 2.944439 0.339286 0.571429 4.369448 0.6325 2 -12 74 767 108 1 0 30 7.6 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 17 5 35 0 11 7 56 0 87 40 125 0 -0.510826 0.5 2.833213 0.485714 2.397895 0.196429 0.485714 4.465908 0.6962 1 0 20 158 101 0 0 127 7.2 6 8.5 0 4.4 3.3 5.2 0 0.6 0.1 1.2 0 19 5 35 0 18 7 56 0 77 40 125 0 -0.510826 0.5 2.944439 0.542857 2.890372 0.321429 0.542857 4.343805 0.6165 1 15 24 792 108 1 0 30 7.5 6 8.5 0 4.6 3.3 5.2 0 0.7 0.1 1.2 0 17 5 35 0 14 7 56 0 78 40 125 0 -0.356675 0.583333 2.833213 0.485714 2.639057 0.25 0.485714 4.356709 0.6241 1 0 27 356 102 5 0 27 7.1 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 22 5 35 0 25 7 56 0 55 40 125 0 -0.693147 0.416667 3.091042 0.628571 3.218876 0.446429 0.628571 4.007333 0.442 1 -14 19 196 101 0 0 127 7.3 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 26 5 35 0 26 7 56 0 71 40 125 0 -0.510826 0.5 3.258097 0.742857 3.258097 0.464286 0.742857 4.26268 0.5685 2 1 71 777 108 0 0 30 7.6 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 17 5 35 0 13 7 56 0 74 40 125 0 -0.510826 0.5 2.833213 0.485714 2.564949 0.232143 0.485714 4.304065 0.5921 1 15 30 341 102 5 0 27 7 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 20 5 35 0 21 7 56 0 56 40 125 0 -0.693147 0.416667 2.995732 0.571429 3.044522 0.375 0.571429 4.025352 0.4482 1 2 27 152 101 4 0 127 7.3 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 23 5 35 0 24 7 56 0 82 40 125 0 -0.510826 0.5 3.135494 0.657143 3.178054 0.428571 0.657143 4.406719 0.6561 1 1 21 211 101 4 0 127 7.4 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 22 5 35 0 17 7 56 0 82 40 125 0 -0.693147 0.416667 3.091042 0.628571 2.833213 0.303571 0.628571 4.406719 0.6565 1 -12 37 706 108 1 0 30 7 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 18 5 35 0 12 7 56 0 72 40 125 0 -0.510826 0.5 2.890372 0.514286 2.484907 0.214286 0.514286 4.276666 0.5764 1 15 25 389 108 2 0 35 7.5 6 8.5 0 4.9 3.3 5.2 0 1 0.1 1.2 0 21 5 35 0 16 7 56 0 64 40 125 0 0 0.833333 3.044522 0.6 2.772589 0.285714 0.6 4.158883 0.5122 1 2 19 159 101 4 0 127 7.6 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 23 5 35 0 19 7 56 0 71 40 125 0 -0.693147 0.416667 3.135494 0.657143 2.944439 0.339286 0.657143 4.26268 0.568

132 2 120 70 1063 108 1 0 30 7.3 6 8.5 0 4.2 3.3 5.2 0 0.6 0.1 1.2 0 16 5 35 0 12 7 56 0 65 40 125 0 -0.510826 0.5 2.772589 0.457143 2.484907 0.214286 0.457143 4.174387 0.525 1 0 28 805 108 1 0 30 7.6 6 8.5 0 4.7 3.3 5.2 0 0.6 0.1 1.2 0 20 5 35 0 13 7 56 0 73 40 125 0 -0.510826 0.5 2.995732 0.571429 2.564949 0.232143 0.571429 4.290459 0.5841 1 20 43 226 101 4 0 127 7.5 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 24 5 35 0 22 7 56 0 61 40 125 0 -0.693147 0.416667 3.178054 0.685714 3.091042 0.392857 0.685714 4.110874 0.488

132 2 36 86 1099 108 1 0 30 7.6 6 8.5 0 4.5 3.3 5.2 0 0.8 0.1 1.2 0 16 5 35 0 14 7 56 0 66 40 125 0 -0.223144 0.666667 2.772589 0.457143 2.639057 0.25 0.457143 4.189655 0.5284 1 12 25 389 108 2 0 35 7.4 6 8.5 0 4.7 3.3 5.2 0 0.8 0.1 1.2 0 20 5 35 0 13 7 56 0 65 40 125 0 -0.223144 0.666667 2.995732 0.571429 2.564949 0.232143 0.571429 4.174387 0.522 1 2 27 183 101 4 0 127 7.4 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 21 5 35 0 23 7 56 0 78 40 125 0 -0.693147 0.416667 3.044522 0.6 3.135494 0.410714 0.6 4.356709 0.6245 1 10 30 741 108 1 0 30 7.7 6 8.5 0 4.8 3.3 5.2 0 0.6 0.1 1.2 0 18 5 35 0 17 7 56 0 82 40 125 0 -0.510826 0.5 2.890372 0.514286 2.833213 0.303571 0.514286 4.406719 0.6561 1 3 27 356 102 5 0 27 7.1 6 8.5 0 4.6 3.3 5.2 0 0.7 0.1 1.2 0 18 5 35 0 20 7 56 0 49 40 125 0 -0.356675 0.583333 2.890372 0.514286 2.995732 0.357143 0.514286 3.89182 0.3922 1 13 21 253 101 4 0 127 7.2 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 21 5 35 0 25 7 56 0 71 40 125 0 -0.693147 0.416667 3.044522 0.6 3.218876 0.446429 0.6 4.26268 0.5681 1 13 23 214 101 4 0 127 7.3 6 8.5 0 4.5 3.3 5.2 0 0.6 0.1 1.2 0 19 5 35 0 18 7 56 0 64 40 125 0 -0.510826 0.5 2.944439 0.542857 2.890372 0.321429 0.542857 4.158883 0.5125 2 15 71 777 108 0 0 30 7.2 6 8.5 0 4.5 3.3 5.2 0 0.7 0.1 1.2 0 13 5 35 0 8 7 56 0 73 40 125 0 -0.356675 0.583333 2.564949 0.371429 2.079442 0.142857 0.371429 4.290459 0.5841 1 23 23 214 101 4 0 127 7.4 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 19 5 35 0 17 7 56 0 67 40 125 0 -0.693147 0.416667 2.944439 0.542857 2.833213 0.303571 0.542857 4.204693 0.5365 2 22 81 831 108 1 0 30 7.2 6 8.5 0 4.3 3.3 5.2 0 0.5 0.1 1.2 0 15 5 35 0 9 7 56 0 80 40 125 0 -0.693147 0.416667 2.70805 0.428571 2.197225 0.160714 0.428571 4.382027 0.641 1 -13 25 225 101 0 0 127 7.2 6 8.5 0 4.3 3.3 5.2 0 0.6 0.1 1.2 0 24 5 35 0 19 7 56 0 64 40 125 0 -0.510826 0.5 3.178054 0.685714 2.944439 0.339286 0.685714 4.158883 0.5121 1 -11 25 225 101 0 0 127 7.2 6 8.5 0 4.3 3.3 5.2 0 0.6 0.1 1.2 0 24 5 35 0 19 7 56 0 64 40 125 0 -0.510826 0.5 3.178054 0.685714 2.944439 0.339286 0.685714 4.158883 0.5124 1 7 39 387 108 2 0 35 7.6 6 8.5 0 5 3.3 5.2 0 0.8 0.1 1.2 0 24 5 35 0 19 7 56 0 52 40 125 0 -0.223144 0.666667 3.178054 0.685714 2.944439 0.339286 0.685714 3.951244 0.4161 1 25 25 335 102 5 0 27 6.9 6 8.5 0 4.5 3.3 5.2 0 0.8 0.1 1.2 0 25 5 35 0 21 7 56 0 59 40 125 0 -0.223144 0.666667 3.218876 0.714286 3.044522 0.375 0.714286 4.077537 0.4722 1 -15 22 173 101 4 0 127 7.3 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 18 5 35 0 17 7 56 0 80 40 125 0 -0.693147 0.416667 2.890372 0.514286 2.833213 0.303571 0.514286 4.382027 0.645 1 7 24 806 108 1 0 30 7.2 6 8.5 0 4.6 3.3 5.2 0 0.8 0.1 1.2 0 20 5 35 0 16 7 56 0 67 40 125 0 -0.223144 0.666667 2.995732 0.571429 2.772589 0.285714 0.571429 4.204693 0.5365 2 -4 71 777 108 0 0 30 7 6 8.5 0 4.4 3.3 5.2 0 0.6 0.1 1.2 0 19 5 35 0 11 7 56 0 72 40 125 0 -0.510826 0.5 2.944439 0.542857 2.397895 0.196429 0.542857 4.276666 0.576

132 2 78 71 973 108 1 0 30 7.5 6 8.5 0 4.3 3.3 5.2 0 0.5 0.1 1.2 0 17 5 35 0 12 7 56 0 75 40 125 0 -0.693147 0.416667 2.833213 0.485714 2.484907 0.214286 0.485714 4.317488 0.61 1 -8 29 234 101 4 0 127 7.1 6 8.5 0 4.4 3.3 5.2 0 0.6 0.1 1.2 0 23 5 35 0 15 7 56 0 82 40 125 0 -0.510826 0.5 3.135494 0.657143 2.70805 0.267857 0.657143 4.406719 0.6562 1 6 27 183 101 4 0 127 7.3 6 8.5 0 4.5 3.3 5.2 0 0.7 0.1 1.2 0 22 5 35 0 25 7 56 0 81 40 125 0 -0.356675 0.583333 3.091042 0.628571 3.218876 0.446429 0.628571 4.394449 0.6485 1 -4 75 763 108 1 0 30 7.4 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 20 5 35 0 13 7 56 0 64 40 125 0 -0.510826 0.5 2.995732 0.571429 2.564949 0.232143 0.571429 4.158883 0.5122 1 0 25 170 101 4 0 127 7.3 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 24 5 35 0 29 7 56 0 67 40 125 0 -0.693147 0.416667 3.178054 0.685714 3.367296 0.517857 0.685714 4.204693 0.5362 1 1 20 158 101 0 0 127 7.3 6 8.5 0 4.5 3.3 5.2 0 0.6 0.1 1.2 0 18 5 35 0 14 7 56 0 81 40 125 0 -0.510826 0.5 2.890372 0.514286 2.639057 0.25 0.514286 4.394449 0.6481 1 7 25 335 102 5 0 27 6.9 6 8.5 0 4.5 3.3 5.2 0 0.9 0.1 1.2 0 25 5 35 0 25 7 56 0 60 40 125 0 -0.105361 0.75 3.218876 0.714286 3.218876 0.446429 0.714286 4.094345 0.482 1 0 19 141 101 0 0 127 7.6 6 8.5 0 4.7 3.3 5.2 0 0.7 0.1 1.2 0 20 5 35 0 17 7 56 0 83 40 125 0 -0.356675 0.583333 2.995732 0.571429 2.833213 0.303571 0.571429 4.418841 0.6645 1 20 20 788 108 1 0 30 7.3 6 8.5 0 4.7 3.3 5.2 0 0.7 0.1 1.2 0 23 5 35 0 15 7 56 0 78 40 125 0 -0.356675 0.583333 3.135494 0.657143 2.70805 0.267857 0.657143 4.356709 0.624

132 2 44 73 1120 108 1 0 30 7.3 6 8.5 0 4.2 3.3 5.2 0 0.5 0.1 1.2 0 16 5 35 0 10 7 56 0 61 40 125 0 -0.693147 0.416667 2.772589 0.457143 2.302585 0.178571 0.457143 4.110874 0.4881 1 2 24 331 102 0 0 27 7.5 6 8.5 0 4.8 3.3 5.2 0 0.7 0.1 1.2 0 19 5 35 0 20 7 56 0 67 40 125 0 -0.356675 0.583333 2.944439 0.542857 2.995732 0.357143 0.542857 4.204693 0.5362 1 0 36 272 101 4 0 127 7.4 6 8.5 0 4.5 3.3 5.2 0 0.7 0.1 1.2 0 19 5 35 0 13 7 56 0 73 40 125 0 -0.356675 0.583333 2.944439 0.542857 2.564949 0.232143 0.542857 4.290459 0.584

132 2 57 71 973 108 1 0 30 7.2 6 8.5 0 4.3 3.3 5.2 0 0.6 0.1 1.2 0 18 5 35 0 9 7 56 0 66 40 125 0 -0.510826 0.5 2.890372 0.514286 2.197225 0.160714 0.514286 4.189655 0.5281 1 0 24 370 102 5 0 27 7.3 6 8.5 0 4.6 3.3 5.2 0 0.7 0.1 1.2 0 26 5 35 0 35 7 56 0 62 40 125 0 -0.356675 0.583333 3.258097 0.742857 3.555348 0.625 0.742857 4.127134 0.4961 1 20 25 335 102 5 0 27 6.7 6 8.5 0 4.4 3.3 5.2 0 0.7 0.1 1.2 0 24 5 35 0 28 7 56 0 58 40 125 0 -0.356675 0.583333 3.178054 0.685714 3.332205 0.5 0.685714 4.060443 0.4642 1 6 30 266 101 0 0 127 7.2 6 8.5 0 4.3 3.3 5.2 0 0.7 0.1 1.2 0 24 5 35 0 20 7 56 0 72 40 125 0 -0.356675 0.583333 3.178054 0.685714 2.995732 0.357143 0.685714 4.276666 0.5761 1 12 33 382 102 5 0 27 6.9 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 25 5 35 0 34 7 56 0 61 40 125 0 -0.510826 0.5 3.218876 0.714286 3.526361 0.607143 0.714286 4.110874 0.4884 1 2 37 390 108 2 0 35 7.4 6 8.5 0 4.7 3.3 5.2 0 0.6 0.1 1.2 0 30 5 35 0 18 7 56 0 64 40 125 0 -0.510826 0.5 3.401197 0.857143 2.890372 0.321429 0.857143 4.158883 0.512

132 2 64 71 973 108 1 0 30 7 6 8.5 0 4.2 3.3 5.2 0 0.6 0.1 1.2 0 16 5 35 0 9 7 56 0 65 40 125 0 -0.510826 0.5 2.772589 0.457143 2.197225 0.160714 0.457143 4.174387 0.521 1 13 21 221 101 4 0 127 7.5 6 8.5 0 4.4 3.3 5.2 0 0.5 0.1 1.2 0 22 5 35 0 17 7 56 0 66 40 125 0 -0.693147 0.416667 3.091042 0.628571 2.833213 0.303571 0.628571 4.189655 0.5281 1 -11 33 85 101 3 0 23 7.4 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 30 5 35 0 22 7 56 0 83 40 125 0 -0.693147 0.416667 3.401197 0.857143 3.091042 0.392857 0.857143 4.418841 0.664

132 2 127 59 1096 108 1 0 30 7.4 6 8.5 0 4.2 3.3 5.2 0 0.5 0.1 1.2 0 17 5 35 0 12 7 56 0 66 40 125 0 -0.693147 0.416667 2.833213 0.485714 2.484907 0.214286 0.485714 4.189655 0.5281 1 1 21 61 101 3 0 23 7.1 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 25 5 35 0 23 7 56 0 84 40 125 0 -0.693147 0.416667 3.218876 0.714286 3.135494 0.410714 0.714286 4.430817 0.6725 2 25 81 831 108 1 0 30 7.3 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 12 5 35 0 9 7 56 0 83 40 125 0 -0.693147 0.416667 2.484907 0.342857 2.197225 0.160714 0.342857 4.418841 0.6645 1 18 24 806 108 1 0 30 7.4 6 8.5 0 4.8 3.3 5.2 0 1 0.1 1.2 0 19 5 35 0 14 7 56 0 71 40 125 0 0 0.833333 2.944439 0.542857 2.639057 0.25 0.542857 4.26268 0.5681 1 2 22 108 101 3 0 23 7.5 6 8.5 0 4.5 3.3 5.2 0 0.5 0.1 1.2 0 23 5 35 0 22 7 56 0 83 40 125 0 -0.693147 0.416667 3.135494 0.657143 3.091042 0.392857 0.657143 4.418841 0.6645 1 -17 27 718 108 0 0 30 7.5 6 8.5 0 4.7 3.3 5.2 0 0.6 0.1 1.2 0 23 5 35 0 17 7 56 0 68 40 125 0 -0.510826 0.5 3.135494 0.657143 2.833213 0.303571 0.657143 4.219508 0.5442 1 6 28 185 101 0 0 127 7 6 8.5 0 4.5 3.3 5.2 0 0.7 0.1 1.2 0 18 5 35 0 19 7 56 0 67 40 125 0 -0.356675 0.583333 2.890372 0.514286 2.944439 0.339286 0.514286 4.204693 0.5365 1 1 22 733 108 1 0 30 7.2 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 19 5 35 0 11 7 56 0 91 40 125 0 -0.510826 0.5 2.944439 0.542857 2.397895 0.196429 0.542857 4.51086 0.728

132 2 -14 79 1065 108 1 0 30 7 6 8.5 0 4.3 3.3 5.2 0 0.5 0.1 1.2 0 15 5 35 0 12 7 56 0 58 40 125 0 -0.693147 0.416667 2.70805 0.428571 2.484907 0.214286 0.428571 4.060443 0.4641 1 23 29 234 101 4 0 127 7.1 6 8.5 0 4.5 3.3 5.2 0 0.7 0.1 1.2 0 19 5 35 0 18 7 56 0 64 40 125 0 -0.356675 0.583333 2.944439 0.542857 2.890372 0.321429 0.542857 4.158883 0.5122 1 -10 30 266 101 0 0 127 7.3 6 8.5 0 4.4 3.3 5.2 0 0.5 0.1 1.2 0 23 5 35 0 17 7 56 0 84 40 125 0 -0.693147 0.416667 3.135494 0.657143 2.833213 0.303571 0.657143 4.430817 0.6721 1 15 29 337 102 0 0 27 6.9 6 8.5 0 4.7 3.3 5.2 0 0.7 0.1 1.2 0 21 5 35 0 24 7 56 0 76 40 125 0 -0.356675 0.583333 3.044522 0.6 3.178054 0.428571 0.6 4.330733 0.6084 1 4 25 389 108 2 0 35 7 6 8.5 0 4.6 3.3 5.2 0 0.7 0.1 1.2 0 22 5 35 0 18 7 56 0 60 40 125 0 -0.356675 0.583333 3.091042 0.628571 2.890372 0.321429 0.628571 4.094345 0.48

132 1 1 68 1086 108 0 0 30 7.3 6 8.5 0 4.4 3.3 5.2 0 0.6 0.1 1.2 0 14 5 35 0 12 7 56 0 65 40 125 0 -0.510826 0.5 2.639057 0.4 2.484907 0.214286 0.4 4.174387 0.525 1 18 20 788 108 1 0 30 7.4 6 8.5 0 4.8 3.3 5.2 0 0.9 0.1 1.2 0 15 5 35 0 14 7 56 0 77 40 125 0 -0.105361 0.75 2.70805 0.428571 2.639057 0.25 0.428571 4.343805 0.6164 1 2 25 389 108 2 0 35 7.5 6 8.5 0 5 3.3 5.2 0 0.9 0.1 1.2 0 27 5 35 0 24 7 56 0 61 40 125 0 -0.105361 0.75 3.295837 0.771429 3.178054 0.428571 0.771429 4.110874 0.4885 1 1 65 819 108 1 0 30 7.6 6 8.5 0 4.6 3.3 5.2 0 0.8 0.1 1.2 0 19 5 35 0 15 7 56 0 77 40 125 0 -0.223144 0.666667 2.944439 0.542857 2.70805 0.267857 0.542857 4.343805 0.6161 1 1 19 60 101 0 0 23 7.2 6 8.5 0 4.6 3.3 5.2 0 0.4 0.1 1.2 0 25 5 35 0 17 7 56 0 75 40 125 0 -0.916291 0.333333 3.218876 0.714286 2.833213 0.303571 0.714286 4.317488 0.62 1 6 29 180 101 0 0 127 7.3 6 8.5 0 4.4 3.3 5.2 0 0.6 0.1 1.2 0 27 5 35 0 28 7 56 0 58 40 125 0 -0.510826 0.5 3.295837 0.771429 3.332205 0.5 0.771429 4.060443 0.4641 1 -11 43 226 101 4 0 127 7.1 6 8.5 0 4.4 3.3 5.2 0 0.4 0.1 1.2 0 27 5 35 0 20 7 56 0 77 40 125 0 -0.916291 0.333333 3.295837 0.771429 2.995732 0.357143 0.771429 4.343805 0.6165 2 3 71 830 108 1 0 30 7 6 8.5 0 4.3 3.3 5.2 0 0.6 0.1 1.2 0 16 5 35 0 8 7 56 0 72 40 125 0 -0.510826 0.5 2.772589 0.457143 2.079442 0.142857 0.457143 4.276666 0.5761 1 -4 26 287 102 0 0 27 7.1 6 8.5 0 4.7 3.3 5.2 0 0.5 0.1 1.2 0 26 5 35 0 30 7 56 0 62 40 125 0 -0.693147 0.416667 3.258097 0.742857 3.401197 0.535714 0.742857 4.127134 0.4961 1 0 28 312 102 0 0 27 6.9 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 24 5 35 0 25 7 56 0 51 40 125 0 -0.693147 0.416667 3.178054 0.685714 3.218876 0.446429 0.685714 3.931826 0.408

132 2 -16 73 921 108 0 0 30 7.7 6 8.5 0 4.4 3.3 5.2 0 0.5 0.1 1.2 0 15 5 35 0 10 7 56 0 58 40 125 0 -0.693147 0.416667 2.70805 0.428571 2.302585 0.178571 0.428571 4.060443 0.4644 1 12 30 392 108 2 0 35 7.4 6 8.5 0 4.7 3.3 5.2 0 0.7 0.1 1.2 0 27 5 35 0 27 7 56 0 62 40 125 0 -0.356675 0.583333 3.295837 0.771429 3.295837 0.482143 0.771429 4.127134 0.4965 1 -5 20 745 108 1 0 30 7.6 6 8.5 0 4.9 3.3 5.2 0 0.7 0.1 1.2 0 15 5 35 0 13 7 56 0 94 40 125 0 -0.356675 0.583333 2.70805 0.428571 2.564949 0.232143 0.428571 4.543295 0.7521 1 5 33 382 102 5 0 27 6.9 6 8.5 0 4.6 3.3 5.2 0 0.9 0.1 1.2 0 22 5 35 0 17 7 56 0 58 40 125 0 -0.105361 0.75 3.091042 0.628571 2.833213 0.303571 0.628571 4.060443 0.4645 1 18 26 781 108 1 0 30 7.2 6 8.5 0 4.6 3.3 5.2 0 0.6 0.1 1.2 0 17 5 35 0 19 7 56 0 80 40 125 0 -0.510826 0.5 2.833213 0.485714 2.944439 0.339286 0.485714 4.382027 0.64

132 2 43 71 973 108 1 0 30 7.2 6 8.5 0 4.3 3.3 5.2 0 0.5 0.1 1.2 0 20 5 35 0 14 7 56 0 75 40 125 0 -0.693147 0.416667 2.995732 0.571429 2.639057 0.25 0.571429 4.317488 0.65 1 -6 25 780 108 1 0 30 7.7 6 8.5 0 4.8 3.3 5.2 0 0.7 0.1 1.2 0 20 5 35 0 17 7 56 0 96 40 125 0 -0.356675 0.583333 2.995732 0.571429 2.833213 0.303571 0.571429 4.564348 0.768

132 2 78 74 1049 108 0 0 30 7.4 6 8.5 0 4.2 3.3 5.2 0 0.7 0.1 1.2 0 18 5 35 0 14 7 56 0 64 40 125 0 -0.356675 0.583333 2.890372 0.514286 2.639057 0.25 0.514286 4.158883 0.5122 1 22 30 266 101 0 0 127 7 6 8.5 0 4.3 3.3 5.2 0 0.5 0.1 1.2 0 25 5 35 0 26 7 56 0 73 40 125 0 -0.693147 0.416667 3.218876 0.714286 3.258097 0.464286 0.714286 4.290459 0.5842 1 0 19 190 101 4 0 127 7.6 6 8.5 0 4.5 3.3 5.2 0 0.6 0.1 1.2 0 22 5 35 0 25 7 56 0 81 40 125 0 -0.510826 0.5 3.091042 0.628571 3.218876 0.446429 0.628571 4.394449 0.6481 1 -1 28 312 102 0 0 27 7.2 6 8.5 0 4.8 3.3 5.2 0 0.6 0.1 1.2 0 19 5 35 0 25 7 56 0 54 40 125 0 -0.510826 0.5 2.944439 0.542857 3.218876 0.446429 0.542857 3.988984 0.4325 1 9 20 788 108 1 0 30 7.2 6 8.5 0 4.7 3.3 5.2 0 0.8 0.1 1.2 0 15 5 35 0 15 7 56 0 79 40 125 0 -0.223144 0.666667 2.70805 0.428571 2.70805 0.267857 0.428571 4.369448 0.632

132 1 44 68 1086 108 0 0 30 7.3 6 8.5 0 4.4 3.3 5.2 0 0.6 0.1 1.2 0 14 5 35 0 11 7 56 0 62 40 125 0 -0.510826 0.5 2.639057 0.4 2.397895 0.196429 0.4 4.127134 0.4961 1 7 20 338 102 5 0 27 7.1 6 8.5 0 4.6 3.3 5.2 0 0.7 0.1 1.2 0 23 5 35 0 17 7 56 0 75 40 125 0 -0.356675 0.583333 3.135494 0.657143 2.833213 0.303571 0.657143 4.317488 0.61 1 1 35 50 101 3 0 23 7.5 6 8.5 0 4.6 3.3 5.2 0 0.5 0.1 1.2 0 18 5 35 0 15 7 56 0 65 40 125 0 -0.693147 0.416667 2.890372 0.514286 2.70805 0.267857 0.514286 4.174387 0.52

132 2 1 73 841 108 1 0 30 7.2 6 8.5 0 4.2 3.3 5.2 0 0.5 0.1 1.2 0 15 5 35 0 9 7 56 0 76 40 125 0 -0.693147 0.416667 2.70805 0.428571 2.197225 0.160714 0.428571 4.330733 0.6081 1 20 21 342 102 0 0 27 6.7 6 8.5 0 4.5 3.3 5.2 0 0.8 0.1 1.2 0 23 5 35 0 25 7 56 0 50 40 125 0 -0.223144 0.666667 3.135494 0.657143 3.218876 0.446429 0.657143 3.912023 0.41 1 13 29 234 101 4 0 127 6.9 6 8.5 0 4.4 3.3 5.2 0 0.5 0.1 1.2 0 19 5 35 0 17 7 56 0 69 40 125 0 -0.693147 0.416667 2.944439 0.542857 2.833213 0.303571 0.542857 4.234107 0.5524 1 15 39 387 108 2 0 35 7.8 6 8.5 0 5.1 3.3 5.2 0 1 0.1 1.2 0 25 5 35 0 20 7 56 0 62 40 125 0 0 0.833333 3.218876 0.714286 2.995732 0.357143 0.714286 4.127134 0.4965 1 10 19 723 108 0 0 30 7.2 6 8.5 0 4.8 3.3 5.2 0 0.9 0.1 1.2 0 17 5 35 0 14 7 56 0 86 40 125 0 -0.105361 0.75 2.833213 0.485714 2.639057 0.25 0.485714 4.454347 0.688

CRF Raw Data Analysis Ready Data Results

Protocol / Statistical Analysis Plan

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