Appendix A: Source Data Programs
This appendix presents Base SAS programs that you can run to generate the source data for the SDTM datasets. The trial design dataset source data are available as a Microsoft Excel file called trialdesign.xlsx that can be downloaded from the author page for this book. See support.sas.com/publishing/authors/index.html.
adverse Dataset
demographics Dataset
proc format;
value trt
1 = "Active"
0 = "Placebo";
value gender
1 = "Male"
2 = "Female";
value race
1 = "White"
2 = "Black"
3 = "Other";
run;
**** INPUT SAMPLE DEMOGRAPHICS DATA;
data source.demographic;
label subject = "Subject Number"
trt = "Treatment"
gender = "Gender"
race = "Race"
orace = "Oher Race Specify"
dob = "Date of Birth"
uniqueid = "Company Wide Subject ID"
randdt = "Randomization Date";
input subject 1-3 trt 5 gender 7 race 9 orace $ 11-20 +1 dob mmddyy10. +1
randdt mmddyy10.;
uniqueid = 'UNI' || put(subject,3.);
format dob randdt mmddyy10.;
datalines;
101 0 1 3 BRAZILIAN 02/05/1974 04/02/2010
102 1 2 1 11/02/1946 02/13/2010
103 1 1 2 05/01/1979 05/16/2010
104 0 2 1 05/01/1972 01/02/2010
105 1 1 3 ABORIGINE 03/02/1979 04/20/2010
106 0 2 1 05/01/1977 04/01/2010
201 1 1 3 LIBYAN 04/28/1949 06/11/2010
202 0 2 1 01/13/1967 02/23/2010
203 1 1 2 01/01/1971 06/10/2010
204 0 2 1 04/17/1950 02/03/2010
205 1 1 3 HMONG 05/13/1978 04/13/2010
206 1 2 1 02/09/1948 07/01/2010
301 0 1 1 04/12/1941 02/20/2010
302 0 1 2 07/02/1978 05/12/2010
303 1 1 1 03/02/1967 02/19/2010
304 0 1 1 03/03/1958 05/19/2010
305 1 1 1 02/28/1966 06/10/2010
306 0 1 2 01/02/1960 05/23/2010
401 1 2 1 10/31/1970 06/13/2010
402 0 2 2 10/12/1980 01/02/2010
403 1 1 1 01/23/1974 03/03/2010
404 1 1 1 03/18/1954 04/24/2010
405 0 2 1 03/19/1939 03/01/2010
406 1 1 2 03/19/1970 06/12/2010
501 0 1 2 06/12/1978 02/23/2010
502 1 2 1 03/16/1967 05/28/2010
503 1 1 1 08/14/1962 01/21/2010
504 0 1 3 JAPANESE 02/01/1977 06/19/2010
505 1 1 2 04/16/1969 03/13/2010
506 0 1 1 07/22/1964 01/20/2010
507 1 1 2 10/22/1976 04/06/2010
508 0 2 1 12/22/1965 02/04/2010
509 0 1 1 12/13/1972 05/16/2010
510 0 1 3 HMONG 07/24/1956 01/12/2010
511 1 2 2 09/28/1960 04/10/2010
512 1 1 1 03/02/1967 04/03/2010
601 0 1 1 01/12/1961 06/04/2010
602 0 2 2 05/09/1971 02/28/2010
603 1 2 1 07/14/1980 01/12/2010
604 0 1 1 11/11/1977 03/13/2010
605 1 2 1 12/31/1955 04/23/2010
606 0 1 2 09/20/1971 02/22/2010
607 1 1 1 10/13/1966 06/10/2010
608 0 2 2 07/15/1967 02/20/2010
609 1 2 1 10/16/1945 05/22/2010
610 0 1 1 06/22/1954 01/09/2010
611 1 2 1 10/18/1949 06/19/2010
612 1 1 2 02/02/1960 03/12/2010
701 1 1 1 12/02/1951 05/12/2010
702 0 1 1 01/29/1955 02/10/2010
703 1 1 2 02/12/1956 05/20/2010
704 0 2 1 12/25/1972 06/01/2010
705 1 1 2 08/23/1981 05/24/2010
706 1 1 1 12/13/1965 06/12/2010
707 1 1 1 12/12/1972 01/12/2010
708 0 2 1 10/13/1978 03/13/2010
709 0 2 2 10/10/1940 04/23/2010
710 0 1 1 08/11/1949 03/16/2010
711 1 1 2 11/19/1950 04/24/2010
712 0 . 1 12/30/1948 06/10/2010
;
run;
dosing Dataset
**** INPUT SAMPLE DOSING DATA;
data source.dosing;
label subject = "Subject Number"
startdt = "Dosing start date"
enddt = "Dosing end date"
dailydose= "Daily dose taken (pills)"
uniqueid = "Company Wide Subject ID"
startmm = "Month of Start Dose"
startdd = "Day of Start Dose"
startyy = "Year of Start Dose"
endmm = "Month of End Dose"
enddd = "Day of End Dose"
endyy = "Year of End Dose";
input subject 1-3 startmm 5-6 startdd 8-9 startyy 11-14
endmm 16-17 enddd 19-20 endyy 22-25 dailydose 27;
uniqueid = 'UNI' || put(subject,3.);
startdt = mdy(startmm, startdd , startyy);
enddt = mdy(endmm, enddd, endyy);
format startdt enddt mmddyy10.;
datalines;
101 04/02/2010 07/26/2010 2
101 07/31/2010 10/10/2010 3
102 02/13/2010 03/20/2010 2
102 03/25/2010 08/10/2010 1
103 05/16/2010 11/14/2010 1
104 01/02/2010 01/10/2010 2
104 01/15/2010 05/25/2010 1
104 05/26/2010 07/04/2010 2
105 04/20/2010 07/20/2010 2
105 07/21/2010 10/19/2010 1
106 04/01/2010 10/10/2010 2
201 06/11/2010 12/11/2010 1
202 02/23/2010 05/19/2010 2
203 06/10/2010 06/20/2010 1
204 02/03/2010 05/04/2010 2
204 05/05/2010 08/03/2010 2
205 04/13/2010 10/10/2010 1
206 07/01/2010 10/01/2010 2
206 10/02/2010 12/27/2010 2
301 02/20/2010 05/17/2010 2
301 05/19/2010 08/22/2010 3
302 05/12/2010 08/12/2010 2
302 08/13/2010 11/15/2010 3
303 02/19/2010 08/17/2010 2
304 05/19/2010 11/19/2010 1
305 06/10/2010 12/11/2010 2
306 05/23/2010 08/19/2010 2
306 08/20/2010 11/18/2010 1
401 06/13/2010 12/09/2010 2
402 01/02/2010 01/05/2010 3
402 01/06/2010 04/02/2010 2
402 04/03/2010 07/10/2010 1
403 03/03/2010 09/04/2010 2
404 04/24/2010 10/25/2010 3
405 03/01/2010 08/28/2010 2
406 06/12/2010 12/09/2010 3
501 02/23/2010 08/17/2010 2
502 05/28/2010 08/25/2010 2
502 08/29/2010 11/20/2010 1
503 01/21/2010 07/19/2010 2
504 06/19/2010 12/20/2010 2
505 03/13/2010 06/15/2010 2
505 06/16/2010 06/20/2010 1
506 01/20/2010 07/20/2010 2
507 04/06/2010 10/05/2010 2
508 02/04/2010 08/11/2010 2
509 05/16/2010 11/15/2010 2
510 01/12/2010 07/14/2010 2
511 04/10/2010 10/12/2010 3
512 04/03/2010 10/01/2010 3
601 06/04/2010 12/09/2010 2
602 02/28/2010 03/24/2010 3
602 03/25/2010 06/22/2010 2
603 01/12/2010 04/12/2010 2
603 04/13/2010 07/10/2010 1
604 03/13/2010 09/15/2010 2
605 04/23/2010 10/26/2010 3
606 02/22/2010 05/25/2010 3
606 05/26/2010 08/23/2010 2
607 06/10/2010 12/09/2010 3
608 02/20/2010 05/20/2010 2
608 05/21/2010 08/17/2010 1
609 05/22/2010 11/23/2010 2
610 01/09/2010 07/12/2010 2
611 06/19/2010 09/21/2010 3
611 09/22/2010 12/20/2010 2
612 03/12/2010 06/15/2010 3
612 06/17/2010 09/16/2010 1
701 05/12/2010 08/10/2010 3
701 08/11/2010 11/05/2010 1
702 02/10/2010 08/12/2010 3
703 05/20/2010 11/20/2010 2
704 06/01/2010 12/10/2010 3
705 05/24/2010 11/19/2010 2
706 06/12/2010 09/11/2010 3
706 09/12/2010 12/10/2010 1
707 01/12/2010 04/11/2010 3
707 04/12/2010 07/10/2010 1
708 03/13/2010 09/15/2010 3
709 04/23/2010 10/23/2010 2
710 03/16/2010 09/16/2010 2
711 04/24/2010 09/20/2010 3
712 / /2010 09/09/2010 3
712 09/10/2010 12/ /2010 2
;
run;
laboratory Dataset
**** INPUT SAMPLE LABORATORY DATA;
data source.labs;
label subject = "Subject Number"
month = "Month: 0=baseline, 1=3 months, 2 =6 months"
labcat = "Category for Lab Test"
labtest = "Laboratory Test"
colunits = "Collected Units"
nresult = "Numeric Result"
lownorm = "Normal Range Lower Limit"
highnorm = "Normal Range Upper Limit"
labdate = "Date of Lab Test"
uniqueid = "Company Wide Subject ID";
format labdate mmddyy10.;
input subject 1-3 month 6 labcat $ 9-18 labtest $ 20-30
colunits $ 32-36 nresult 38-41 lownorm 45-48 highnorm 52-55 +1
labdate mmddyy10.;
uniqueid = 'UNI' || put(subject,3.);
datalines;
101 0 HEMATOLOGY HEMATOCRIT % 31 35 49 04/02/2010
101 1 HEMATOLOGY HEMATOCRIT % 39 35 49 07/03/2010
101 2 HEMATOLOGY HEMATOCRIT % 44 35 49 10/10/2010
101 0 HEMATOLOGY HEMOGLOBIN g/dL 11.5 11.7 15.9 04/02/2010
101 1 HEMATOLOGY HEMOGLOBIN g/dL 13.2 11.7 15.9 07/03/2010
101 2 HEMATOLOGY HEMOGLOBIN g/dL 14.3 11.7 15.9 10/10/2010
101 0 CHEMISTRY AST (SGOT) IU/L 12 10 34 04/02/2010
101 1 CHEMISTRY AST (SGOT) IU/L 40 10 34 07/03/2010
101 2 CHEMISTRY AST (SGOT) IU/L 44 10 34 10/10/2010
101 0 CHEMISTRY ALT (SGPT) IU/L 10 5 35 04/02/2010
101 1 CHEMISTRY ALT (SGPT) IU/L 22 5 35 07/03/2010
101 2 CHEMISTRY ALT (SGPT) IU/L 33 5 35 10/10/2010
101 0 CHEMISTRY ALK. PHOS. IU/L 33 20 140 04/02/2010
101 1 CHEMISTRY ALK. PHOS. IU/L 49 20 140 07/03/2010
101 2 CHEMISTRY ALK. PHOS. IU/L 200 20 140 10/10/2010
101 0 CHEMISTRY GGTP IU/L 5 0 51 04/02/2010
101 1 CHEMISTRY GGTP IU/L 15 0 51 07/03/2010
101 2 CHEMISTRY GGTP IU/L 15 0 51 10/10/2010
101 0 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 04/02/2010
101 1 CHEMISTRY DIRECT BILI mg/dL 0.2 0 0.3 07/03/2010
101 2 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 10/10/2010
101 0 CHEMISTRY TOTAL BILI mg/dL 1.0 0.3 1.9 04/02/2010
101 1 CHEMISTRY TOTAL BILI mg/dL 0.5 0.3 1.9 07/03/2010
101 2 CHEMISTRY TOTAL BILI mg/dL 2.5 0.3 1.9 10/10/2010
101 0 CHEMISTRY ALBUMIN g/dL 3.3 3.4 5.4 04/02/2010
101 1 CHEMISTRY ALBUMIN g/dL 4.1 3.4 5.4 07/03/2010
101 2 CHEMISTRY ALBUMIN g/dL 5.5 3.4 5.4 10/10/2010
101 0 CHEMISTRY TOTAL PROT g/dL 6.4 6.0 8.3 04/02/2010
101 1 CHEMISTRY TOTAL PROT g/dL 7.0 6.0 8.3 07/03/2010
101 2 CHEMISTRY TOTAL PROT g/dL 8.2 6.0 8.3 10/10/2010
102 0 HEMATOLOGY HEMATOCRIT % 39 35 49 02/13/2010
102 1 HEMATOLOGY HEMATOCRIT % 39 35 49 05/10/2010
102 2 HEMATOLOGY HEMATOCRIT % 44 35 49 08/11/2010
102 0 HEMATOLOGY HEMOGLOBIN g/dL 11.5 11.7 15.9 02/13/2010
102 1 HEMATOLOGY HEMOGLOBIN g/dL 13.2 11.7 15.9 05/10/2010
102 2 HEMATOLOGY HEMOGLOBIN g/dL 18.3 11.7 15.9 08/11/2010
102 0 CHEMISTRY AST (SGOT) IU/L 14 10 34 02/13/2010
102 1 CHEMISTRY AST (SGOT) IU/L 45 10 34 05/10/2010
102 2 CHEMISTRY AST (SGOT) IU/L 34 10 34 08/11/2010
102 0 CHEMISTRY ALT (SGPT) IU/L 10 5 35 02/13/2010
102 1 CHEMISTRY ALT (SGPT) IU/L 22 5 35 05/10/2010
102 2 CHEMISTRY ALT (SGPT) IU/L 36 5 35 08/11/2010
102 0 CHEMISTRY ALK. PHOS. IU/L 33 20 140 02/13/2010
102 1 CHEMISTRY ALK. PHOS. IU/L 55 20 140 05/10/2010
102 2 CHEMISTRY ALK. PHOS. IU/L 150 20 140 08/11/2010
102 0 CHEMISTRY GGTP IU/L 20 0 51 02/13/2010
102 1 CHEMISTRY GGTP IU/L 25 0 51 05/10/2010
102 2 CHEMISTRY GGTP IU/L 25 0 51 08/11/2010
102 0 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 02/13/2010
102 1 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 05/10/2010
102 2 CHEMISTRY DIRECT BILI mg/dL 0.4 0 0.3 08/11/2010
102 0 CHEMISTRY TOTAL BILI mg/dL 1.1 0.3 1.9 02/13/2010
102 1 CHEMISTRY TOTAL BILI mg/dL 1.5 0.3 1.9 05/10/2010
102 2 CHEMISTRY TOTAL BILI mg/dL 2.5 0.3 1.9 08/11/2010
102 0 CHEMISTRY ALBUMIN g/dL 3.3 3.4 5.4 02/13/2010
102 1 CHEMISTRY ALBUMIN g/dL 4.1 3.4 5.4 05/10/2010
102 2 CHEMISTRY ALBUMIN g/dL 5.2 3.4 5.4 08/11/2010
102 0 CHEMISTRY TOTAL PROT g/dL 6.3 6.0 8.3 02/13/2010
102 1 CHEMISTRY TOTAL PROT g/dL 7.1 6.0 8.3 05/10/2010
102 2 CHEMISTRY TOTAL PROT g/dL 8.3 6.0 8.3 08/11/2010
103 0 HEMATOLOGY HEMATOCRIT % 54 35 49 05/15/2010
103 1 HEMATOLOGY HEMATOCRIT % 33 35 49 08/15/2010
103 2 HEMATOLOGY HEMATOCRIT % 52 35 49 11/15/2010
103 0 HEMATOLOGY HEMOGLOBIN g/dL 12.5 11.7 15.9 05/15/2010
103 1 HEMATOLOGY HEMOGLOBIN g/dL 12.2 11.7 15.9 08/15/2010
103 2 HEMATOLOGY HEMOGLOBIN g/dL 14.3 11.7 15.9 11/15/2010
103 0 CHEMISTRY AST (SGOT) IU/L 19 10 34 05/15/2010
103 1 CHEMISTRY AST (SGOT) IU/L 41 10 34 08/15/2010
103 2 CHEMISTRY AST (SGOT) IU/L 34 10 34 11/15/2010
103 0 CHEMISTRY ALT (SGPT) IU/L 13 5 35 05/15/2010
103 1 CHEMISTRY ALT (SGPT) IU/L 22 5 35 08/15/2010
103 2 CHEMISTRY ALT (SGPT) IU/L 34 5 35 11/15/2010
103 0 CHEMISTRY ALK. PHOS. IU/L 33 20 140 05/15/2010
103 1 CHEMISTRY ALK. PHOS. IU/L 120 20 140 08/15/2010
103 2 CHEMISTRY ALK. PHOS. IU/L 110 20 140 11/15/2010
103 0 CHEMISTRY GGTP IU/L 5 0 51 05/15/2010
103 1 CHEMISTRY GGTP IU/L 25 0 51 08/15/2010
103 2 CHEMISTRY GGTP IU/L 33 0 51 11/15/2010
103 0 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 05/15/2010
103 1 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 08/15/2010
103 2 CHEMISTRY DIRECT BILI mg/dL 0.2 0 0.3 11/15/2010
103 0 CHEMISTRY TOTAL BILI mg/dL 1.1 0.3 1.9 05/15/2010
103 1 CHEMISTRY TOTAL BILI mg/dL 1.5 0.3 1.9 08/15/2010
103 2 CHEMISTRY TOTAL BILI mg/dL 2.7 0.3 1.9 11/15/2010
103 0 CHEMISTRY ALBUMIN g/dL 3.3 3.4 5.4 05/15/2010
103 1 CHEMISTRY ALBUMIN g/dL 4.2 3.4 5.4 08/15/2010
103 2 CHEMISTRY ALBUMIN g/dL 5.3 3.4 5.4 11/15/2010
103 0 CHEMISTRY TOTAL PROT g/dL 6.2 6.0 8.3 05/15/2010
103 1 CHEMISTRY TOTAL PROT g/dL 7.1 6.0 8.3 08/15/2010
103 2 CHEMISTRY TOTAL PROT g/dL 8.4 6.0 8.3 11/15/2010
104 0 HEMATOLOGY HEMATOCRIT % 50 35 49 01/02/2010
104 1 HEMATOLOGY HEMATOCRIT % 42 35 49 04/03/2010
104 2 HEMATOLOGY HEMATOCRIT % 42 35 49 07/04/2010
104 0 HEMATOLOGY HEMOGLOBIN g/dL 13.0 11.7 15.9 01/02/2010
104 1 HEMATOLOGY HEMOGLOBIN g/dL 13.3 11.7 15.9 04/03/2010
104 2 HEMATOLOGY HEMOGLOBIN g/dL 12.8 11.7 15.9 07/04/2010
104 0 CHEMISTRY AST (SGOT) IU/L 22 10 34 01/02/2010
104 1 CHEMISTRY AST (SGOT) IU/L 23 10 34 04/03/2010
104 2 CHEMISTRY AST (SGOT) IU/L 22 10 34 07/04/2010
104 0 CHEMISTRY ALT (SGPT) IU/L 12 5 35 01/02/2010
104 1 CHEMISTRY ALT (SGPT) IU/L 22 5 35 04/03/2010
104 2 CHEMISTRY ALT (SGPT) IU/L 23 5 35 07/04/2010
104 0 CHEMISTRY ALK. PHOS. IU/L 30 20 140 01/02/2010
104 1 CHEMISTRY ALK. PHOS. IU/L 37 20 140 04/03/2010
104 2 CHEMISTRY ALK. PHOS. IU/L 100 20 140 07/04/2010
104 0 CHEMISTRY GGTP IU/L 34 0 51 01/02/2010
104 1 CHEMISTRY GGTP IU/L 22 0 51 04/03/2010
104 2 CHEMISTRY GGTP IU/L 34 0 51 07/04/2010
104 0 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 01/02/2010
104 1 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 04/03/2010
104 2 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 07/04/2010
104 0 CHEMISTRY TOTAL BILI mg/dL 1.3 0.3 1.9 01/02/2010
104 1 CHEMISTRY TOTAL BILI mg/dL 1.5 0.3 1.9 04/03/2010
104 2 CHEMISTRY TOTAL BILI mg/dL 1.8 0.3 1.9 07/04/2010
104 0 CHEMISTRY ALBUMIN g/dL 3.6 3.4 5.4 01/02/2010
104 1 CHEMISTRY ALBUMIN g/dL 4.3 3.4 5.4 04/03/2010
104 2 CHEMISTRY ALBUMIN g/dL 5.3 3.4 5.4 07/04/2010
104 0 CHEMISTRY TOTAL PROT g/dL 6.2 6.0 8.3 01/02/2010
104 1 CHEMISTRY TOTAL PROT g/dL 7.2 6.0 8.3 04/03/2010
104 2 CHEMISTRY TOTAL PROT g/dL 8.3 6.0 8.3 07/04/2010
105 0 HEMATOLOGY HEMATOCRIT % 39 35 49 04/20/2010
105 1 HEMATOLOGY HEMATOCRIT % 35 35 49 07/20/2010
105 2 HEMATOLOGY HEMATOCRIT % 37 35 49 10/19/2010
105 0 HEMATOLOGY HEMOGLOBIN g/dL 13.0 11.7 15.9 04/20/2010
105 1 HEMATOLOGY HEMOGLOBIN g/dL 14.2 11.7 15.9 07/20/2010
105 2 HEMATOLOGY HEMOGLOBIN g/dL 14.6 11.7 15.9 10/19/2010
105 0 CHEMISTRY AST (SGOT) IU/L 22 10 34 04/20/2010
105 1 CHEMISTRY AST (SGOT) IU/L 23 10 34 07/20/2010
105 2 CHEMISTRY AST (SGOT) IU/L 22 10 34 10/19/2010
105 0 CHEMISTRY ALT (SGPT) IU/L 12 5 35 04/20/2010
105 1 CHEMISTRY ALT (SGPT) IU/L 22 5 35 07/20/2010
105 2 CHEMISTRY ALT (SGPT) IU/L 23 5 35 10/19/2010
105 0 CHEMISTRY ALK. PHOS. IU/L 30 20 140 04/20/2010
105 1 CHEMISTRY ALK. PHOS. IU/L 37 20 140 07/20/2010
105 2 CHEMISTRY ALK. PHOS. IU/L 100 20 140 10/19/2010
105 0 CHEMISTRY GGTP IU/L 34 0 51 04/20/2010
105 1 CHEMISTRY GGTP IU/L 22 0 51 07/20/2010
105 2 CHEMISTRY GGTP IU/L 34 0 51 10/19/2010
105 0 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 04/20/2010
105 1 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 07/20/2010
105 2 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 10/19/2010
105 0 CHEMISTRY TOTAL BILI mg/dL 1.3 0.3 1.9 04/20/2010
105 1 CHEMISTRY TOTAL BILI mg/dL 1.5 0.3 1.9 07/20/2010
105 2 CHEMISTRY TOTAL BILI mg/dL 1.8 0.3 1.9 10/19/2010
105 0 CHEMISTRY ALBUMIN g/dL 3.6 3.4 5.4 04/20/2010
105 1 CHEMISTRY ALBUMIN g/dL 4.3 3.4 5.4 07/20/2010
105 2 CHEMISTRY ALBUMIN g/dL 5.3 3.4 5.4 10/19/2010
105 0 CHEMISTRY TOTAL PROT g/dL 6.2 6.0 8.3 04/20/2010
105 1 CHEMISTRY TOTAL PROT g/dL 7.2 6.0 8.3 07/20/2010
105 2 CHEMISTRY TOTAL PROT g/dL 8.3 6.0 8.3 10/19/2010
106 0 HEMATOLOGY HEMATOCRIT % 53 35 49 04/01/2010
106 1 HEMATOLOGY HEMATOCRIT % 50 35 49 07/05/2010
106 2 HEMATOLOGY HEMATOCRIT % 53 35 49 10/10/2010
106 0 HEMATOLOGY HEMOGLOBIN g/dL 17.0 11.7 15.9 04/01/2010
106 1 HEMATOLOGY HEMOGLOBIN g/dL 12.3 11.7 15.9 07/05/2010
106 2 HEMATOLOGY HEMOGLOBIN g/dL 12.9 11.7 15.9 10/10/2010
106 0 CHEMISTRY AST (SGOT) IU/L 22 10 34 04/01/2010
106 1 CHEMISTRY AST (SGOT) IU/L 33 10 34 07/05/2010
106 2 CHEMISTRY AST (SGOT) IU/L 36 10 34 10/10/2010
106 0 CHEMISTRY ALT (SGPT) IU/L 13 5 35 04/01/2010
106 1 CHEMISTRY ALT (SGPT) IU/L 24 5 35 07/05/2010
106 2 CHEMISTRY ALT (SGPT) IU/L 29 5 35 10/10/2010
106 0 CHEMISTRY ALK. PHOS. IU/L 30 20 140 04/01/2010
106 1 CHEMISTRY ALK. PHOS. IU/L 50 20 140 07/05/2010
106 2 CHEMISTRY ALK. PHOS. IU/L 90 20 140 10/10/2010
106 0 CHEMISTRY GGTP IU/L 33 0 51 04/01/2010
106 1 CHEMISTRY GGTP IU/L 66 0 51 07/05/2010
106 2 CHEMISTRY GGTP IU/L 60 0 51 10/10/2010
106 0 CHEMISTRY DIRECT BILI mg/dL 0.2 0 0.3 04/01/2010
106 1 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 07/05/2010
106 2 CHEMISTRY DIRECT BILI mg/dL 0.2 0 0.3 10/10/2010
106 0 CHEMISTRY TOTAL BILI mg/dL 1.4 0.3 1.9 04/01/2010
106 1 CHEMISTRY TOTAL BILI mg/dL 1.6 0.3 1.9 07/05/2010
106 2 CHEMISTRY TOTAL BILI mg/dL 1.7 0.3 1.9 10/10/2010
106 0 CHEMISTRY ALBUMIN g/dL 3.9 3.4 5.4 04/01/2010
106 1 CHEMISTRY ALBUMIN g/dL 4.4 3.4 5.4 07/05/2010
106 2 CHEMISTRY ALBUMIN g/dL 5.5 3.4 5.4 10/10/2010
106 0 CHEMISTRY TOTAL PROT g/dL 6.0 6.0 8.3 04/01/2010
106 1 CHEMISTRY TOTAL PROT g/dL 7.1 6.0 8.3 07/05/2010
106 2 CHEMISTRY TOTAL PROT g/dL 8.8 6.0 8.3 10/10/2010
201 0 HEMATOLOGY HEMATOCRIT % 48 35 49 06/10/2010
201 1 HEMATOLOGY HEMATOCRIT % 59 35 49 09/09/2010
201 2 HEMATOLOGY HEMATOCRIT % 60 35 49 12/12/2010
201 0 HEMATOLOGY HEMOGLOBIN g/dL 15.0 11.7 15.9 06/10/2010
201 1 HEMATOLOGY HEMOGLOBIN g/dL 14.3 11.7 15.9 09/09/2010
201 2 HEMATOLOGY HEMOGLOBIN g/dL 19.1 11.7 15.9 12/12/2010
201 0 CHEMISTRY AST (SGOT) IU/L 20 10 34 06/10/2010
201 1 CHEMISTRY AST (SGOT) IU/L 21 10 34 09/09/2010
201 2 CHEMISTRY AST (SGOT) IU/L 20 10 34 12/12/2010
201 0 CHEMISTRY ALT (SGPT) IU/L 13 5 35 06/10/2010
201 1 CHEMISTRY ALT (SGPT) IU/L 20 5 35 09/09/2010
201 2 CHEMISTRY ALT (SGPT) IU/L 39 5 35 12/12/2010
201 0 CHEMISTRY ALK. PHOS. IU/L 32 20 140 06/10/2010
201 1 CHEMISTRY ALK. PHOS. IU/L 33 20 140 09/09/2010
201 2 CHEMISTRY ALK. PHOS. IU/L 111 20 140 12/12/2010
201 0 CHEMISTRY GGTP IU/L 32 0 51 06/10/2010
201 1 CHEMISTRY GGTP IU/L 23 0 51 09/09/2010
201 2 CHEMISTRY GGTP IU/L 39 0 51 12/12/2010
201 0 CHEMISTRY DIRECT BILI mg/dL 0.09 0 0.3 06/10/2010
201 1 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 09/09/2010
201 2 CHEMISTRY DIRECT BILI mg/dL 0.2 0 0.3 12/12/2010
201 0 CHEMISTRY TOTAL BILI mg/dL 1.4 0.3 1.9 06/10/2010
201 1 CHEMISTRY TOTAL BILI mg/dL 1.7 0.3 1.9 09/09/2010
201 2 CHEMISTRY TOTAL BILI mg/dL 1.3 0.3 1.9 12/12/2010
201 0 CHEMISTRY ALBUMIN g/dL 3.3 3.4 5.4 06/10/2010
201 1 CHEMISTRY ALBUMIN g/dL 4.9 3.4 5.4 09/09/2010
201 2 CHEMISTRY ALBUMIN g/dL 5.2 3.4 5.4 12/12/2010
201 0 CHEMISTRY TOTAL PROT g/dL 6.3 6.0 8.3 06/10/2010
201 1 CHEMISTRY TOTAL PROT g/dL 7.4 6.0 8.3 09/09/2010
201 2 CHEMISTRY TOTAL PROT g/dL 8.9 6.0 8.3 12/12/2010
202 0 HEMATOLOGY HEMATOCRIT % 41 35 49 01/23/2010
202 1 HEMATOLOGY HEMATOCRIT % 52 35 49 04/20/2010
202 2 HEMATOLOGY HEMATOCRIT % 48 35 49 07/20/2010
202 0 HEMATOLOGY HEMOGLOBIN g/dL 15.1 11.7 15.9 01/23/2010
202 1 HEMATOLOGY HEMOGLOBIN g/dL 18.2 11.7 15.9 04/20/2010
202 2 HEMATOLOGY HEMOGLOBIN g/dL 17.7 11.7 15.9 07/20/2010
202 0 CHEMISTRY AST (SGOT) IU/L 22 10 34 01/23/2010
202 1 CHEMISTRY AST (SGOT) IU/L 23 10 34 04/20/2010
202 2 CHEMISTRY AST (SGOT) IU/L 22 10 34 07/20/2010
202 0 CHEMISTRY ALT (SGPT) IU/L 12 5 35 01/23/2010
202 1 CHEMISTRY ALT (SGPT) IU/L 22 5 35 04/20/2010
202 2 CHEMISTRY ALT (SGPT) IU/L 23 5 35 07/20/2010
202 0 CHEMISTRY ALK. PHOS. IU/L 30 20 140 01/23/2010
202 1 CHEMISTRY ALK. PHOS. IU/L 37 20 140 04/20/2010
202 2 CHEMISTRY ALK. PHOS. IU/L 100 20 140 07/20/2010
202 0 CHEMISTRY GGTP IU/L 34 0 51 01/23/2010
202 1 CHEMISTRY GGTP IU/L 22 0 51 04/20/2010
202 2 CHEMISTRY GGTP IU/L 34 0 51 07/20/2010
202 0 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 01/23/2010
202 1 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 04/20/2010
202 2 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 07/20/2010
202 0 CHEMISTRY TOTAL BILI mg/dL 1.3 0.3 1.9 01/23/2010
202 1 CHEMISTRY TOTAL BILI mg/dL 1.5 0.3 1.9 04/20/2010
202 2 CHEMISTRY TOTAL BILI mg/dL 1.8 0.3 1.9 07/20/2010
202 0 CHEMISTRY ALBUMIN g/dL 3.6 3.4 5.4 01/23/2010
202 1 CHEMISTRY ALBUMIN g/dL 4.3 3.4 5.4 04/20/2010
202 2 CHEMISTRY ALBUMIN g/dL 5.3 3.4 5.4 07/20/2010
202 0 CHEMISTRY TOTAL PROT g/dL 6.2 6.0 8.3 01/23/2010
202 1 CHEMISTRY TOTAL PROT g/dL 7.2 6.0 8.3 04/20/2010
202 2 CHEMISTRY TOTAL PROT g/dL 8.3 6.0 8.3 07/20/2010
203 0 HEMATOLOGY HEMATOCRIT % 39 35 49 06/10/2010
203 1 HEMATOLOGY HEMATOCRIT % 53 35 49 09/01/2010
203 2 HEMATOLOGY HEMATOCRIT % 57 35 49 11/28/2010
203 0 HEMATOLOGY HEMOGLOBIN g/dL 13.0 11.7 15.9 06/10/2010
203 1 HEMATOLOGY HEMOGLOBIN g/dL 17.3 11.7 15.9 09/01/2010
203 2 HEMATOLOGY HEMOGLOBIN g/dL 17.3 11.7 15.9 11/28/2010
203 0 CHEMISTRY AST (SGOT) IU/L 17 10 34 06/10/2010
203 1 CHEMISTRY AST (SGOT) IU/L 20 10 34 09/01/2010
203 2 CHEMISTRY AST (SGOT) IU/L 33 10 34 11/28/2010
203 0 CHEMISTRY ALT (SGPT) IU/L 8 5 35 06/10/2010
203 1 CHEMISTRY ALT (SGPT) IU/L 12 5 35 09/01/2010
203 2 CHEMISTRY ALT (SGPT) IU/L 22 5 35 11/28/2010
203 0 CHEMISTRY ALK. PHOS. IU/L 22 20 140 06/10/2010
203 1 CHEMISTRY ALK. PHOS. IU/L 33 20 140 09/01/2010
203 2 CHEMISTRY ALK. PHOS. IU/L 56 20 140 11/28/2010
203 0 CHEMISTRY GGTP IU/L 12 0 51 06/10/2010
203 1 CHEMISTRY GGTP IU/L 33 0 51 09/01/2010
203 2 CHEMISTRY GGTP IU/L 29 0 51 11/28/2010
203 0 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 06/10/2010
203 1 CHEMISTRY DIRECT BILI mg/dL 0.2 0 0.3 09/01/2010
203 2 CHEMISTRY DIRECT BILI mg/dL 0.3 0 0.3 11/28/2010
203 0 CHEMISTRY TOTAL BILI mg/dL 1.0 0.3 1.9 06/10/2010
203 1 CHEMISTRY TOTAL BILI mg/dL 0.4 0.3 1.9 09/01/2010
203 2 CHEMISTRY TOTAL BILI mg/dL 1.2 0.3 1.9 11/28/2010
203 0 CHEMISTRY ALBUMIN g/dL 3.6 3.4 5.4 06/10/2010
203 1 CHEMISTRY ALBUMIN g/dL 4.8 3.4 5.4 09/01/2010
203 2 CHEMISTRY ALBUMIN g/dL 5.4 3.4 5.4 11/28/2010
203 0 CHEMISTRY TOTAL PROT g/dL 6.3 6.0 8.3 06/10/2010
203 1 CHEMISTRY TOTAL PROT g/dL 7.4 6.0 8.3 09/01/2010
203 2 CHEMISTRY TOTAL PROT g/dL 8.4 6.0 8.3 11/28/2010
204 0 HEMATOLOGY HEMATOCRIT % 38 35 49 02/03/2010
204 1 HEMATOLOGY HEMATOCRIT % 40 35 49 05/04/2010
204 2 HEMATOLOGY HEMATOCRIT % 44 35 49 08/05/2010
204 0 HEMATOLOGY HEMOGLOBIN g/dL 11.2 11.7 15.9 02/03/2010
204 1 HEMATOLOGY HEMOGLOBIN g/dL 12.2 11.7 15.9 05/04/2010
204 2 HEMATOLOGY HEMOGLOBIN g/dL 17.3 11.7 15.9 08/05/2010
204 0 CHEMISTRY AST (SGOT) IU/L 20 10 34 02/03/2010
204 1 CHEMISTRY AST (SGOT) IU/L 33 10 34 05/04/2010
204 2 CHEMISTRY AST (SGOT) IU/L 45 10 34 08/05/2010
204 0 CHEMISTRY ALT (SGPT) IU/L 10 5 35 02/03/2010
204 1 CHEMISTRY ALT (SGPT) IU/L 20 5 35 05/04/2010
204 2 CHEMISTRY ALT (SGPT) IU/L 40 5 35 08/05/2010
204 0 CHEMISTRY ALK. PHOS. IU/L 32 20 140 02/03/2010
204 1 CHEMISTRY ALK. PHOS. IU/L 33 20 140 05/04/2010
204 2 CHEMISTRY ALK. PHOS. IU/L 160 20 140 08/05/2010
204 0 CHEMISTRY GGTP IU/L 32 0 51 02/03/2010
204 1 CHEMISTRY GGTP IU/L 21 0 51 05/04/2010
204 2 CHEMISTRY GGTP IU/L 33 0 51 08/05/2010
204 0 CHEMISTRY DIRECT BILI mg/dL 0.2 0 0.3 02/03/2010
204 1 CHEMISTRY DIRECT BILI mg/dL 0.1 0 0.3 05/04/2010
204 2 CHEMISTRY DIRECT BILI mg/dL 0.2 0 0.3 08/05/2010
204 0 CHEMISTRY TOTAL BILI mg/dL 1.6 0.3 1.9 02/03/2010
204 1 CHEMISTRY TOTAL BILI mg/dL 1.2 0.3 1.9 05/04/2010
204 2 CHEMISTRY TOTAL BILI mg/dL 1.8 0.3 1.9 08/05/2010
204 0 CHEMISTRY ALBUMIN g/dL 3.6 3.4 5.4 02/03/2010
204 1 CHEMISTRY ALBUMIN g/dL 4.2 3.4 5.4 05/04/2010
204 2 CHEMISTRY ALBUMIN g/dL 5.1 3.4 5.4 08/05/2010
204 0 CHEMISTRY TOTAL PROT g/dL 6.3 6.0 8.3 02/03/2010
204 1 CHEMISTRY TOTAL PROT g/dL 7.4 6.0 8.3 05/04/2010
204 2 CHEMISTRY TOTAL PROT g/dL 8.2 6.0 8.3 08/05/2010
;
run;
pain scores Dataset
**** INPUT SAMPLE EFFICACY PAIN DATA;
data source.pain;
label subject = "Subject Number"
randomizedt = "Baseline visit date"
month3dt = "Month 3 visit date"
month6dt = "Month 6 visit date"
painbase = "Pain score at baseline: 0=none, 1=mild, 2=moderate,
3=severe"
pain3mo = "Pain score at 3 months: 0=none, 1=mild, 2=moderate,
3=severe"
pain6mo = "Pain score at 6 months: 0=none, 1=mild, 2=moderate,
3=severe"
uniqueid = "Company Wide Subject ID";
input subject randomizedt mmddyy10. +1 month3dt mmddyy10. +1 month6dt mmddyy10. painbase pain3mo pain6mo;
uniqueid = 'UNI' || put(subject,3.);
format randomizedt month3dt month6dt mmddyy10.;
datalines;
101 04/02/2010 07/03/2010 10/10/2010 3 2 1
102 02/13/2010 05/10/2010 08/11/2010 3 3 1
103 05/15/2010 08/15/2010 11/15/2010 3 3 0
104 01/02/2010 04/03/2010 07/04/2010 2 0 0
105 04/20/2010 07/20/2010 10/19/2010 3 3 1
106 04/01/2010 07/05/2010 10/10/2010 3 0 0
201 06/10/2010 09/09/2010 12/12/2010 3 2 0
202 01/23/2010 04/20/2010 07/20/2010 3 1 1
203 06/10/2010 . . 3 . .
204 02/03/2010 05/04/2010 08/05/2010 3 2 1
205 04/13/2010 07/12/2010 10/10/2010 3 2 3
206 07/01/2010 10/01/2010 12/28/2010 2 2 0
301 02/20/2010 05/19/2010 08/22/2010 3 1 1
302 05/12/2010 08/13/2010 11/15/2010 3 3 3
303 02/19/2010 05/17/2010 08/17/2010 3 2 1
304 05/19/2010 08/15/2010 11/20/2010 3 0 0
305 06/10/2010 09/09/2010 12/12/2010 3 3 0
306 05/23/2010 08/20/2010 11/19/2010 3 0 0
401 06/13/2010 09/11/2010 12/10/2010 3 3 3
402 01/02/2010 04/02/2010 07/10/2010 2 3 3
403 03/03/2010 06/04/2010 09/05/2010 2 3 1
404 04/23/2010 07/24/2010 10/26/2010 2 3 0
405 02/28/2010 05/25/2010 08/28/2010 3 0 0
406 06/12/2010 09/10/2010 12/09/2010 3 3 3
501 02/23/2010 05/20/2010 08/17/2010 3 0 0
502 05/27/2010 08/25/2010 11/20/2010 2 0 0
503 01/19/2010 04/20/2010 07/19/2010 1 0 0
504 06/19/2010 09/20/2010 12/20/2010 2 0 0
505 03/12/2010 06/15/2010 . 3 0 .
506 01/20/2010 04/19/2010 07/20/2010 3 0 0
507 04/06/2010 07/03/2010 10/06/2010 3 0 0
508 02/03/2010 05/09/2010 08/11/2010 3 1 1
509 05/15/2010 08/15/2010 11/15/2010 3 2 0
510 01/12/2010 04/13/2010 07/14/2010 2 1 0
511 04/10/2010 07/10/2010 10/13/2010 3 1 1
512 04/01/2010 07/01/2010 10/01/2010 3 2 0
601 06/03/2010 09/09/2010 12/09/2010 3 1 0
602 02/28/2010 03/25/2010 06/23/2010 2 0 0
603 01/12/2010 04/12/2010 07/10/2010 2 0 0
604 03/13/2010 06/14/2010 09/15/2010 2 1 1
605 04/23/2010 07/24/2010 10/26/2010 3 3 0
606 02/22/2010 05/25/2010 08/23/2010 2 0 0
607 06/10/2010 09/10/2010 12/09/2010 3 1 0
608 02/20/2010 05/20/2010 08/17/2010 3 1 0
609 05/22/2010 08/25/2010 11/23/2010 3 3 2
610 01/09/2010 04/10/2010 07/12/2010 2 0 0
611 06/19/2010 09/21/2010 12/20/2010 3 1 1
612 03/12/2010 06/15/2010 09/16/2010 3 1 1
701 05/12/2010 08/10/2010 11/10/2010 2 0 0
702 02/09/2010 05/10/2010 08/12/2010 3 0 0
703 05/19/2010 08/20/2010 11/20/2010 3 1 0
704 06/01/2010 09/09/2010 12/10/2010 2 3 0
705 05/20/2010 08/20/2010 11/19/2010 3 1 1
706 06/12/2010 09/11/2010 12/10/2010 3 1 2
707 01/12/2010 04/12/2010 07/10/2010 2 1 1
708 03/13/2010 06/14/2010 09/15/2010 3 1 1
709 04/23/2010 07/24/2010 10/23/2010 3 1 0
710 03/16/2010 06/16/2010 09/16/2010 2 2 2
711 04/22/2010 07/22/2010 09/20/2010 2 0 0
712 06/10/2010 09/09/2010 12/09/2010 2 1 0
;
run;