data demog; label subjid = "Subject Number" trt = "Treatment" gender = "Gender" race = "Race" age = "Age"; input

subjid trt gender race age @@; datalines; 101 0 1 3 37 301 0 1 1 70 501 0 1 2 33 102 1 2 1 65 302 0 1 2 55 502 1 2 1 44 103 1 1 2 32 303 1 1 1 65 503 1 1 1 64 104 0 2 1 23 304 0 1 1 45 504 0 1 3 56 105 1 1 3 44 305 1 1 1 36 505 1 1 2 73 106 0 2 1 49 306 0 1 2 46 506 0 1 1 46 201 1 1 3 35 401 1 2 1 44 507 1 1 2 44 202 0 2 1 50 402 0 2 2 77 508 0 2 1 53 203 1 1 2 49 403 1 1 1 45 509 0 1 1 45 204 0 2 1 60 404 1 1 1 59 510 0 1 3 65 205 1 1 3 39 405 0 2 1 49 511 1 2 2 43 206 1 2 1 67 406 1 1 2 33 512 1 1 1 39 ; run;

601 602 603 604 605 606 607 608 609 610 611 612

0 0 1 0 1 0 1 0 1 0 1 1

1 2 2 1 2 1 1 2 2 1 2 1

1 2 1 1 1 2 1 2 1 1 1 2

50 30 33 65 57 56 67 46 72 29 65 46

701 702 703 704 705 706 707 708 709 710 711 712

1 0 1 0 1 1 1 0 0 0 1 0

1 1 1 2 1 1 1 2 2 1 1 .

1 1 2 1 2 1 1 1 2 1 2 1

60 28 44 66 46 75 46 55 57 63 61 49

**** CREATE FORMATS NEEDED FOR TABLE ROWS.; proc format; value gender 1 = "Male" 2 = "Female"; value race 1 = "White" 2 = "Black" 3 = "Other*"; run; **** DUPLICATE THE INCOMING DATA SET FOR OVERALL COLUMN **** CALCULATIONS SO NOW TRT HAS VALUES 0 = PLACEBO, 1 = ACTIVE, **** AND 2 = OVERALL.; data demog; set demog; output; trt = 2; output; run; **** AGE STATISTICS PROGRAMMING ********************************; **** GET P VALUE FROM NON PARAMETRIC COMPARISON OF AGE MEANS.; proc npar1way data = demog wilcoxon noprint; where trt in (0,1); class trt; var age; output out = pvalue wilcoxon; run; proc sort data = demog; by trt; run; ***** GET AGE DESCRIPTIVE STATISTICS N, MEAN, STD, MIN, AND MAX.; proc univariate data = demog noprint; by trt; var age;

output out = age n = _n mean = _mean std = _std min = _min max = _max; run; **** FORMAT AGE DESCRIPTIVE STATISTICS FOR THE TABLE.; data age; set age; format n mean sd min max $14.; drop _n _mean _std _min _max; n = put(_n,3.); mean = put(_mean,7.1); std = put(_std,8.2); min = put(_min,7.1); max = put(_max,7.1); run; **** TRANSPOSE AGE DESCRIPTIVE STATISTICS INTO COLUMNS.; proc transpose data = age out = age prefix = col; var n mean std min max; id trt; run; **** CREATE AGE FIRST ROW FOR THE TABLE.; data label; set pvalue(keep = p2_wil rename = (p2_wil = pvalue)); length label $ 85; label = "Age (years)"; run; **** APPEND AGE DESCRIPTIVE STATISTICS TO AGE P VALUE ROW AND **** CREATE AGE DESCRIPTIVE STATISTIC ROW LABELS.; data age; length label $ 85 col0 col1 col2 $ 25 ; set label age; keep label col0 col1 col2 pvalue ; if _n_ > 1 then select; when(_NAME_ = 'n') label = " N"; when(_NAME_ = 'mean') label = " Mean"; when(_NAME_ = 'std') label = " Standard Deviation"; when(_NAME_ = 'min') label = " Minimum"; when(_NAME_ = 'max') label = " Maximum"; otherwise; end; run; **** END OF AGE STATISTICS PROGRAMMING *************************; **** GENDER STATISTICS PROGRAMMING *****************************; **** GET SIMPLE FREQUENCY COUNTS FOR GENDER.; proc freq data = demog noprint; where trt ne .; tables trt * gender / missing outpct out = gender; run; **** FORMAT GENDER N(%) AS DESIRED.; data gender; set gender; where gender ne .; length value $25; value = put(count,4.) || ' (' || put(pct_row,5.1)||'%)'; run;

proc sort data = gender; by gender; run; **** TRANSPOSE THE GENDER SUMMARY STATISTICS.; proc transpose data = gender out = gender(drop = _name_) prefix = col; by gender; var value; id trt; run; **** PERFORM CHI-SQUARE ON GENDER COMPARING ACTIVE VS PLACEBO.; proc freq data = demog noprint; where gender ne . and trt not in (.,2); table gender * trt / chisq; output out = pvalue pchi; run; **** CREATE GENDER FIRST ROW FOR THE TABLE.; data label; set pvalue(keep = p_pchi rename = (p_pchi = pvalue)); length label $ 85; label = "Gender"; run; **** APPEND GENDER DESCRIPTIVE STATISTICS TO GENDER P VALUE ROW **** AND CREATE GENDER DESCRIPTIVE STATISTIC ROW LABELS.; data gender; length label $ 85 col0 col1 col2 $ 25 ; set label gender; keep label col0 col1 col2 pvalue ; if _n_ > 1 then label= " " || put(gender,gender.); run; **** END OF GENDER STATISTICS PROGRAMMING **********************; **** RACE STATISTICS PROGRAMMING *******************************; **** GET SIMPLE FREQUENCY COUNTS FOR RACE; proc freq data = demog noprint; where trt ne .; tables trt * race / missing outpct out = race; run; **** FORMAT RACE N(%) AS DESIRED; data race; set race; where race ne .; length value $25; value = put(count,4.) || ' (' || put(pct_row,5.1)||'%)'; run; proc sort data = race; by race; run; **** TRANSPOSE THE RACE SUMMARY STATISTICS; proc transpose data = race out = race(drop = _name_) prefix=col; by race;

var value; id trt; run; **** PERFORM FISHER'S EXACT ON RACE COMPARING ACTIVE VS PLACEBO.; proc freq data = demog noprint; where race ne . and trt not in (.,2); table race * trt / exact; output out = pvalue exact; run; **** CREATE RACE FIRST ROW FOR THE TABLE.; data label; set pvalue(keep = xp2_fish rename = (xp2_fish = pvalue)); length label $ 85; label = "Race"; run; **** APPEND RACE DESCRIPTIVE STATISTICS TO RACE P VALUE ROW AND **** CREATE RACE DESCRIPTIVE STATISTIC ROW LABELS.; data race; length label $ 85 col0 col1 col2 $ 25 ; set label race; keep label col0 col1 col2 pvalue ; if _n_ > 1 then label= " " || put(race,race.); run; **** END OF RACE STATISTICS PROGRAMMING ************************; **** CONCATENATE AGE, GENDER, AND RACE STATISTICS AND CREATE **** GROUPING GROUP VARIABLE FOR LINE SKIPPING IN PROC REPORT.; data forreport; set age(in = in1) gender(in = in2) race(in = in3); group = sum(in1 * 1, in2 * 2, in3 * 3); run; **** DEFINE THREE MACRO VARIABLES &N0, &N1, AND &NT THAT ARE USED **** IN THE COLUMN HEADERS FOR "PLACEBO," "ACTIVE" AND "OVERALL" **** THERAPY GROUPS.; data _null_; set demog end = eof; **** CREATE COUNTER FOR N0 = PLACEBO, N1 = ACTIVE.; if trt = 0 then n0 + 1; else if trt = 1 then n1 + 1; **** CREATE OVERALL COUNTER NT.; nt + 1; **** CREATE MACRO VARIABLES &N0, &N1, AND &NT.; if eof then do; call symput("n0",compress('(N='||put(n0,4.) || ')')); call symput("n1",compress('(N='||put(n1,4.) || ')')); call symput("nt",compress('(N='||put(nt,4.) || ')')); end; run; **** USE PROC REPORT TO WRITE THE TABLE TO FILE.; options nonumber nodate ls = 84 missing = " " formchar = "|----|+|---+=|-/\<>*"; proc report data = forreport nowindows

spacing = 1 headline headskip split = "|"; columns ("--" group label col1 col0 col2 pvalue); define group /order order = internal noprint; define label /display width=23 " "; define col0 /display center width = 14 "Placebo|&n0"; define col1 /display center width = 14 "Active|&n1"; define col2 /display center width = 14 "Overall|&nt"; define pvalue /display center width = 14 " |P-value**" f = pvalue6.4; break after group / skip; title1 "Company " " "; title2 "Protocol Name " " "; title3 "Table 5.3"; title4 "Demographics"; footnote1 "------------------------------------------" "-----------------------------------------"; footnote2 "* Other includes Asian, Native Amerian, and other" " races. "; footnote3 "** P-values: Age = Wilcoxon rank-sum, Gender " "= Pearson's chi-square, "; footnote4 " Race = Fisher's exact test. " " "; footnote5 "Created by %sysfunc(getoption(sysin)) on" " &sysdate9.."; run;