Document text
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]***********************************************************************************************;
** Program Name : adsl-s005-all1-ped6-saf.sas **;** Date Created : 15Nov2021 **;** Programmer Name : **;
** Purpose : Create adsl-s005-all1-ped6-saf **;** Input data : adsl **;** Output file : adsl-s005-all1-ped6-saf.html **;***********************************************************************************************;options mprint mlogic symbolgen mprint symbolgen mlogic nocenter missing=" ";ods escapechar="~";
proc datasets library=WORK kill nolist nodetails;
quit;
**Setup the environment**;
%let bprot=/Volumes/app/cdars/prod/sites/cdars4/prjC459/nda2_unblinded_esub/sbla1215_esub_adam/saseng/cdisc3_0/;%let prot=/Volumes/app/cdars/prod/sites/cdars4/
prjC459/nda2_unblinded_esub/sbla1215_esub_adam/saseng/cdisc3_0;
%let codename=adsl-s005-all1-ped6-saf;
libname datvprot "&bprot.data_vai" access=readonly;
%let outlog=&prot./analysis/eSUB/logs/&codename..log;%let outtable=&prot./analysis/eSUB/output/&codename..html;
proc printto log="&outlog." new;
run;
******************************************************************************************;
* Clean *;******************************************************************************************;
proc delete data=work._all_;
run;
proc format;
value cov 1="Positive" 2="Negative" other="Missing"; value sars 1="Positive(*ESC*){super c}" 2="Negative(*ESC*){super d}" other="Missing"; value cd 1="<200 cells/mm(*ESC*){super 3}" 2="200-500 cells/mm(*ESC*){super 3}" 3=">500 cells/mm(*ESC*){super 3}"; value rna 1="(*ESC*){Unicode 003C}50 copies/mL" 2="(*ESC*){unicode 2265}50 copies/mL"; value sex 1='Male' 2='Female'; value arace 1='White' 2='Black or African American' 3='American Indian or Alaska Native' 4='Asian' 5='Native Hawaiian or other Pacific Islander' 6='Multiracial' 7='Not reported' 8='Unknown' 999='All others~{super c}'; value ethnic 1='Hispanic/Latino' 2='Non-Hispanic/non-Latino' 3='Not reported' 4='Unknown'; value RANDAGE 1='12-15 Years' 2='16-55 Years' 3='18-55 Years' 4='65-85 Years' 5='>55 Years'; value Raciald 1="Indian Subcontinent Asian" 10="African Caribbean"
(b) (4), (b) (6)
FDA-CBER-2022-5812-0072618
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] 11="Saudi Arabian" 12="Malay" 13="Filipino" 14="Vietnamese"
15="Australian Aboriginal" 16="Torres Strait Islander" 17="Han Chinese"
18="Non-Han Chinese" 19="Ashkenazi Jew" 2="Southeast Asian" 3="Far East Asian" 4="Japanese American" 5="Japanese" 6="Korean" 7="Chinese" 8="African" 9="African American" 999="Other"; value BMICAT 1="Underweight ((*ESC*){Unicode 003C}18.5 kg/m~{super 2})" 2=" Normal weight ((*ESC*){Unicode 2265}18.5 kg/m~{super 2} - 24.9 kg/m~{super 2})" 3="Overweight ((*ESC*){Unicode 2265}25.0 kg/m~{super 2} - 29.9 kg/m~{super 2})" 4="Obese ((*ESC*){Unicode 2265}30.0 kg/m~{super 2})" 5="Missing"; value obes 1="Yes" 2="No";run;
data adsl;
set DATVPROT.ADSL(rename=(ethnic=ethnic1)); length ethnic $50;
if covblst="POS" then
do; covblst="Positive"; covblstc="Positive(*ESC*){super c}"; covblstn=1; end; else if covblst="NEG" then do; covblst="Negative"; covblstc="Negative(*ESC*){super d}"; covblstn=2; end;
/* else covblstn=.;*/
else do; covblst="Missing"; covblstc="Missing"; covblstn=999; end;
if upcase(ethnic1)='NOT HISPANIC OR LATINO' then
ethnic='Non-Hispanic/Non-Latino'; else if upcase(ethnic1)='HISPANIC OR LATINO' then ethnic='Hispanic/Latino'; else if upcase(ethnic1)='NOT REPORTED' then ethnic='Not Reported';run;
data adsl;
set adsl; length countryx $50;
if country='ARG' then
countryx='Argentina'; else if country='BRA' then countryx='Brazil';
else if country='DEU' then
FDA-CBER-2022-5812-0072619
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] countryx='Germany';
else if country='TUR' then
countryx='Turkey'; else if country='USA' then countryx='USA'; else if country='ZAF' then countryx='South Africa'; else countryx='Others';run;
data adsl;
set adsl;
if trt01an=8 and agegr4n=1 then
trtarn=1; else if trt01an=8 and agegr4n=2 then trtarn=2; else if trt01an=9 and agegr4n=1 then trtarn=3; else if trt01an=9 and agegr4n=2 then trtarn=4; trtar=trt01a;
if COMBODFL='Y' or OBESEFL="Y" then
do; COMBODFLNX=1; COMBODFLX="Yes"; end; else do; COMBODFLNX=2; COMBODFLX="No"; end;
if obesefl="Y" then
do; obeseflc="Yes"; obesefln=1; end; else if obesefl="N" then do; obeseflc="No"; obesefln=2; end;
if racialdn=999 then
racialdn=.;run;
data g_adsl_dsin;
set adsl; where SAFFL eq 'Y' and AGEGR4N=1 and phasen ne 1;
run;
FDA-CBER-2022-5812-0072620
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]data __trtmap;
length trtcode trtdecd $100;
if 0 then
set g_adsl_dsin(keep=TRT01AN); trtval=1;
if vtype(TRT01AN)='C' then
trtcode=tranwrd(compbl(quote("8")), ' ', '" "'); else trtcode="8"; trtdecd="BNT162b2 (30 (*ESC*){unicode 03BC}g)"; trtvar="TRT01AN"; trtlbl="TRT01A"; output; trtval=2;
if vtype(TRT01AN)='C' then
trtcode=tranwrd(compbl(quote("9")), ' ', '" "'); else trtcode="9"; trtdecd="Placebo"; trtvar="TRT01AN"; trtlbl="TRT01A"; output; trtval=3;
if vtype(TRT01AN)='C' then
trtcode=tranwrd(compbl(quote("8 9")), ' ', '" "'); else trtcode="8 9"; trtdecd="Total"; trtvar="TRT01AN"; trtlbl="TRT01A"; output; stop;run;
data g_adsl_dsin;
set g_adsl_dsin;
if TRT01AN in (8) then
do; newtrtn=1; newtrt=coalescec("BNT162b2 (30 (*ESC*){unicode 03BC}g)", TRT01A); output; end;
if TRT01AN in (9) then
do; newtrtn=2; newtrt=coalescec("Placebo", TRT01A); output;
FDA-CBER-2022-5812-0072621
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] end;
if TRT01AN in (8 9) then
do; newtrtn=3; newtrt=coalescec("Total", TRT01A); output; end;run;
*----------------------------------------------------------------------;
* Initialize dataset for non-pvalue footnote queue. ;*----------------------------------------------------------------------;
data _stdft1(compress=no);
length model $200 mark $5; index=0; model=' '; mark=' ';run;
*----------------------------------------------------------------------;
* Initialize dataset for pvalue related footnote queue.;*----------------------------------------------------------------------;
data _stdft2(compress=no);
length model $200 mark $5; index=0; model=' '; mark=' ';run;
*----------------------------------------------------------------------;
* Initialize structure for _BASETEMPLATE dataset. ;*----------------------------------------------------------------------;
data _basetemplate(compress=no);
length _varname $8 _cvalue $35 _direct $20 _vrlabel $200 _rwlabel _colabel $800 _datatyp $5 _module $8 _pr_lbl $ 200; array _c _character_; delete;run;
*----------------------------------------------------------------------;
* Create next _DATAn dataset ;*----------------------------------------------------------------------;
data _data1;
set g_adsl_dsin; where (NEWTRTN is not missing);run;
*----------------------------------------------------------------------;
* Count number of treatment groups ;
FDA-CBER-2022-5812-0072622
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]*----------------------------------------------------------------------;
proc sql noprint;
select count(unique NEWTRTN) into :_trtn from _data1 where NEWTRTN is not missing;quit;
*----------------------------------------------------------------------;
* Generate variable _TRT. Use assigned order if applicable ;*----------------------------------------------------------------------;
proc sort data=_data1;
by NEWTRTN USUBJID;run;
data _data1;
retain _trt 0; length _str $200; _datasrt=1; set _data1 end=eof; by NEWTRTN USUBJID; drop _str; _str=' '; _lastby=1; _dummyby=0;
if first.NEWTRTN then
do;
if not missing(NEWTRTN) then
do; _trt=_trt + 1; end; *----------------------------------------------------------------------; * Generate _STR as the treatment label ; *----------------------------------------------------------------------; _str=NEWTRT; *----------------------------------------------------------------------; * Update _TRTLB&n with generated treatment label ; *----------------------------------------------------------------------;
if _trt > 0 then
call symput('_trtlb'||compress(put(_trt, 4.)), trim(left(_str))); end;run;
*----------------------------------------------------------------------;
* Count number of patients in each treatment. ;*----------------------------------------------------------------------;
proc sql noprint;
select compress(put(count(*), 5.) ) into :_trt1 - :_trt3 from (select distinct USUBJID, _trt from _data1 where NEWTRTN is not missing) group by _trt;
select compress(put(count(*), 5.) ) into :_trt4 from (select distinct USUBJID
FDA-CBER-2022-5812-0072623
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] from _data1 where NEWTRTN is not missing);
quit;
*----------------------------------------------------------------------;
* Generate a dataset containing all by-variables ;*----------------------------------------------------------------------;
proc sort data=_data1 out=_bydat1(keep=_datasrt _dummyby) nodupkey;
by _datasrt;run;
data _bydat1;
set _bydat1 end=eof; by _datasrt; retain _preby 0; drop _preby; _byvar1=0;
if eof then
do; call symput("_preby1", compress(put(_byvar1, 4.)));
if 0=0 then
output; end;run;
data _bydat1;
set _bydat1; by _datasrt; length _bycol _byindnt $50 _bylast $10; _bycol=" "; _byindnt=" "; _bylast=" ";run;
proc sort data=_bydat1;
by _datasrt;run;
proc sort data=_data1 out=_data1;
by _datasrt;run;
data _anal1;
length SEXN 8; set _data1;
if SEXN=. then
SEXN=9998; _blcksrt=1; _cnt=1; _cat=1;
FDA-CBER-2022-5812-0072624
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] if _trt <=0 then
delete;
output;run;
proc sort data=_anal1;
by _datasrt _blcksrt SEXN _trt _cat;run;
*--- Counts for each by-sequence, dependant var, and treatment combination ---*;data _temp1;
set _anal1; output;run;
proc sort data=_temp1 out=_temp91 nodupkey;
by _datasrt _blcksrt _cat SEXN _trt USUBJID;run;
proc freq data=_temp91;
format SEXN; tables _datasrt*_blcksrt*_cat * SEXN * _trt / sparse norow nocol nopercent out=_pct1(drop=percent);run;
proc sort data=_anal1 out=_denom1(keep=_datasrt _cat) nodupkey;
by _datasrt _cat;run;
data _denom1;
set _denom1; by _datasrt _cat; label count='count'; _trt=1; count=&_trt1; output; _trt=2; count=&_trt2; output; _trt=3; count=&_trt3; output;run;
*----------------------------------------------------------------------;
* Create _DENOMF a frame dataset for the denominators ;*----------------------------------------------------------------------;
data _denomf1;
_datasrt=1; set _bydat1(keep=); * All treatment groups ;
_trt1=0;
FDA-CBER-2022-5812-0072625
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] _trt2=0;
_trt3=0;
* _CAT is the subgroup variable ; _cat=1; output;run;
*----------------------------------------------------------------------;
* Transpose _DENOM into _DENOMIN to get COUNT as _TRTn columns ;*----------------------------------------------------------------------;
proc sql noprint;
select put(nobs - delobs, 12.) into :_nobs from dictionary.tables where (libname="WORK" and memname="_DENOM1"); select setting into :miss from dictionary.options where upcase(optname)="MISSING";quit;
proc transpose data=_denom1 out=_denomin1(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat; var count; id _trt;run;
*----------------------------------------------------------------------;
* VALRANGE=FULL. Create full rank categories WITHOUT using where. ;*----------------------------------------------------------------------;
proc sql noprint;
select count(distinct SEXN) into : totexpv from _anal1; select distinct SEXN into :expv1 - :expv2 from _anal1 order by SEXN;quit;
*----------------------------------------------------------------------;
* Create _FRAME dataset using all combinations of category variable ;*----------------------------------------------------------------------;
data _frame1;
_datasrt=1; set _bydat1(keep=); _blcksrt=1; length SEXN 8; _catLabl=" "; _trt=1; SEXN=1; _catord=1; _cat=1; output; _trt=2; SEXN=1; _catord=1; _cat=1; output;
_trt=3;
FDA-CBER-2022-5812-0072626
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] SEXN=1;
_catord=1;
_cat=1; output; _catLabl=" "; _trt=1; SEXN=2; _catord=2; _cat=1; output; _trt=2; SEXN=2; _catord=2; _cat=1; output; _trt=3; SEXN=2; _catord=2; _cat=1; output;run;
*----------------------------------------------------------------------;
* Merge the _PCT dataset with its frameup dataset(_FRAME) ;*----------------------------------------------------------------------;
proc sort data=_frame1;
by _datasrt _blcksrt _cat SEXN _trt;run;
proc sort data=_pct1;
by _datasrt _blcksrt _cat SEXN _trt;run;
data _pct1;
merge _frame1(in=_inframe) _pct1; by _datasrt _blcksrt _cat SEXN _trt;
if _inframe; if count=. then
count=0;run;
*----------------------------------------------------------------------;
* Delete Zero filled MISSING category rows for each combination of;* _datasrt &_byvar _blcksrt;*----------------------------------------------------------------------;
proc sort data=_pct1;
by _datasrt _blcksrt SEXN;run;
data _miss1(keep=_datasrt _blcksrt SEXN totcount);
FDA-CBER-2022-5812-0072627
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] set _pct1;
where SEXN=9998;
retain totcount; by _datasrt _blcksrt SEXN;
if first.SEXN then
totcount=0; totcount=totcount+count;
if last.SEXN;
run;
data _pct1(drop=totcount);
merge _pct1 _miss1; by _datasrt _blcksrt SEXN;
if totcount=0 then
delete;run;
*******************************************************************;
*IF PCTDISP=CAT/DPTVAR then add dptvar into denomitor frame dataset;*******************************************************************;*----------------------------------------------------------------------;* Merge the _DENOMIN with its frame up dataset (_denomf) ;*----------------------------------------------------------------------;
proc sort data=_denomf1;
by _datasrt _cat;run;
proc sort data=_denomin1;
by _datasrt _cat;run;
data _denomin1;
merge _denomf1(in=_inframe) _denomin1; by _datasrt _cat;
if _inframe;
_blcksrt=1;run;
*----------------------------------------------------------------------;
* Merge in _PCT(counts) with the _DENOMIN(denominator for percents) ;*----------------------------------------------------------------------;
proc sort data=_pct1;
by _datasrt _cat;run;
*----------------------------------------------------------------------;
* Create _VARNAME variable to hold depend variable name. ;
* Create _VRLABEL variable to display Group label. ;
FDA-CBER-2022-5812-0072628
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]* Create _RWLABEL variable to display &dptvar categories. ;
*----------------------------------------------------------------------;
data _pct1;
if 0 then set _basetemplate; merge _denomin1(in=_a) _pct1; by _datasrt _cat;
if _a;
_varname="SEXN "; _vrlabel="Sex "; _rwlabel=put(SEXN, sex.);
if SEXN=9998 then
do; _rwlabel="Unknown "; _catord=9998; end; else if SEXN=9999 then do; _rwlabel="Total "; _catord=9999; end;
if _catord=. then
_catord=9997;run;
proc sort data=_pct1;
by _datasrt _blcksrt _catord SEXN _trt _cat;run;
*----------------------------------------------------------------------;
* Create _CVALUE variable to display results. ;* Create _ROWSRT variable to order results. ;*----------------------------------------------------------------------;
data _base1;
length _catlabl $200; set _pct1 end=eof; by _datasrt _blcksrt _catord SEXN _trt _cat; retain _rowsrt 0 _rowmax 0; array _trtcnt(*) _trt1-_trt4; drop _rowmax _cpct; length _cpct $100; _cpct=' '; _module='mcatstat';
if count > . then
_cvalue=put(count, 5.);
else
_cvalue=put(0, 5.);
*----------------------------------------------------------------------;
FDA-CBER-2022-5812-0072629
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] * Format percent to append to display value in _CVALUE ;
*----------------------------------------------------------------------;
if _trt ne . then
do;
if _trtcnt(_trt) > 0 then
do;
percent=count / _trtcnt(_trt) * 100;
if percent > 0 then
do;
if round(percent, 0.1) GE 0.1 then
_cpct="(*ESC*){nbspace 1}("||strip(put(percent, 5.1))||")";
else
_cpct="(*ESC*){nbspace 1}(0.0)";
_cvalue=trim(_cvalue)||_cpct;
end;
end;
end;
if length(_cvalue) < 13 then
do;
*----------------------------------------------------------------------;
* Put character A0x at right most character to pad text;
*----------------------------------------------------------------------;
substr(_cvalue, 13, 1)='A0'x;
end;
if first.SEXN then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=3;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
FDA-CBER-2022-5812-0072630
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]data _anal2;
length ARACEN 8;
set _data1;
where same and ARACEN is not missing;
_blcksrt=2;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal2;
by _datasrt _blcksrt ARACEN _trt _cat;
run;*--- Counts for each by-sequence, dependant var, and treatment combination ---*;data _temp2;
set _anal2;
output;
run;proc sort data=_temp2 out=_temp92 nodupkey;
by _datasrt _blcksrt _cat ARACEN _trt USUBJID;
;
run;proc freq data=_temp92;
format ARACEN;
tables _datasrt*_blcksrt*_cat * ARACEN * _trt / sparse norow nocol nopercent
out=_pct2(drop=percent);
run;proc sort data=_anal2 out=_denom2(keep=_datasrt _cat) nodupkey;
by _datasrt _cat;
run;data _denom2;
set _denom2;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1;
output;
_trt=2;
count=&_trt2;
output;
_trt=3;
count=&_trt3;
output;
run;
FDA-CBER-2022-5812-0072631
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]*----------------------------------------------------------------------;
* Create _DENOMF a frame dataset for the denominators ;*----------------------------------------------------------------------;
data _denomf2;
_datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
_trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;*----------------------------------------------------------------------;
* Transpose _DENOM into _DENOMIN to get COUNT as _TRTn columns ;*----------------------------------------------------------------------;
proc sql noprint;
select put(nobs - delobs, 12.) into :_nobs from dictionary.tables
where (libname="WORK" and memname="_DENOM2");
select setting into :miss from dictionary.options where
upcase(optname)="MISSING";
quit;;proc transpose data=_denom2 out=_denomin2(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;*----------------------------------------------------------------------;
* Create _FRAME dataset using all combinations of category variable ;*----------------------------------------------------------------------;
data _frame2;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=2;
length ARACEN 8;
_catLabl=" ";
_trt=1;
ARACEN=1;
_catord=1;
_cat=1;
output;
_trt=2;
ARACEN=1;
_catord=1;
FDA-CBER-2022-5812-0072632
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] _cat=1;
output;
_trt=3;
ARACEN=1;
_catord=1;
_cat=1;
output;
_catLabl=" ";
_trt=1;
ARACEN=2;
_catord=2;
_cat=1;
output;
_trt=2;
ARACEN=2;
_catord=2;
_cat=1;
output;
_trt=3;
ARACEN=2;
_catord=2;
_cat=1;
output;
run;
*----------------------------------------------------------------------;
* Merge the _PCT dataset with its frameup dataset(_FRAME) ;*----------------------------------------------------------------------;
proc sort data=_frame2;
by _datasrt _blcksrt _cat ARACEN _trt;
run;proc sort data=_pct2;
by _datasrt _blcksrt _cat ARACEN _trt;
run;data _pct2;
merge _frame2(in=_inframe) _pct2;
by _datasrt _blcksrt _cat ARACEN _trt;
if _inframe;
if count=. then
count=0;
run;*----------------------------------------------------------------------;
* Delete Zero filled MISSING category rows for each combination of;* _datasrt &_byvar _blcksrt;*----------------------------------------------------------------------;
proc sort data=_pct2;
by _datasrt _blcksrt ARACEN;
FDA-CBER-2022-5812-0072633
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]run;
data _miss2(keep=_datasrt _blcksrt ARACEN totcount);
set _pct2;
where ARACEN=9998;
retain totcount;
by _datasrt _blcksrt ARACEN;
if first.ARACEN then
totcount=0;
totcount=totcount+count;
if last.ARACEN;
run;
data _pct2(drop=totcount);
merge _pct2 _miss2;
by _datasrt _blcksrt ARACEN;
if totcount=0 then
delete;
run;proc sort data=_denomf2;
by _datasrt _cat;
run;proc sort data=_denomin2;
by _datasrt _cat;
run;data _denomin2;
merge _denomf2(in=_inframe) _denomin2;
by _datasrt _cat;
if _inframe;
_blcksrt=2;
run;*----------------------------------------------------------------------;
* Merge in _PCT(counts) with the _DENOMIN(denominator for percents) ;*----------------------------------------------------------------------;
proc sort data=_pct2;
by _datasrt _cat;
run;data _pct2;
if 0 then
set _basetemplate;
merge _denomin2(in=_a) _pct2;
by _datasrt _cat;
if _a;
FDA-CBER-2022-5812-0072634
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] _varname="ARACEN ";
_vrlabel="Race ";
_rwlabel=put(ARACEN, arace.);
if ARACEN=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if ARACEN=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct2;
by _datasrt _blcksrt _catord ARACEN _trt _cat;
run;*----------------------------------------------------------------------;
* Create _CVALUE variable to display results. ;* Create _ROWSRT variable to order results. ;*----------------------------------------------------------------------;
data _base2;
length _catlabl $200;
set _pct2 end=eof;
by _datasrt _blcksrt _catord ARACEN _trt _cat;
retain _rowsrt 0 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
_cpct=' ';
_module='mcatstat';
if count > . then
_cvalue=put(count, 5.);
else
_cvalue=put(0, 5.);
*----------------------------------------------------------------------;
* Format percent to append to display value in _CVALUE ;
*----------------------------------------------------------------------;
if _trt ne . then
do;
if _trtcnt(_trt) > 0 then
do;
percent=count / _trtcnt(_trt) * 100;
FDA-CBER-2022-5812-0072635
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] if percent > 0 then
do;
if round(percent, 0.1) GE 0.1 then
_cpct="(*ESC*){nbspace 1}("||strip(put(percent, 5.1))||")";
else
_cpct="(*ESC*){nbspace 1}(0.0)";
_cvalue=trim(_cvalue)||_cpct;
end;
end;
end;
/* if length(_cvalue) < 13 then do; */
*----------------------------------------------------------------------;
* Put character A0x at right most character to pad text;
*----------------------------------------------------------------------;
/* substr(_cvalue,13,1)= 'A0'x ; */
/* end; */
if first.ARACEN then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=3;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
data _data1;
set _data1;
if Aracen in (3, 4, 5, 6, 7, 8) then
newrace="Y";
run;data _anal3;
length NEWRACE $4;
set _data1;
FDA-CBER-2022-5812-0072636
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] where same and NEWRACE is not missing;
_blcksrt=2;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal3;
by _datasrt _blcksrt NEWRACE _trt _cat;
run;*--- Counts for each by-sequence, dependant var, and treatment combination ---*;data _temp3;
set _anal3;
output;
run;proc sort data=_temp3 out=_temp93 nodupkey;
by _datasrt _blcksrt _cat NEWRACE _trt USUBJID;
run;proc freq data=_temp93;
format NEWRACE;
tables _datasrt*_blcksrt*_cat * NEWRACE * _trt / sparse norow nocol nopercent
out=_pct3(drop=percent);
run;proc sort data=_anal3 out=_denom3(keep=_datasrt _cat) nodupkey;
by _datasrt _cat;
run;data _denom3;
set _denom3;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1;
output;
_trt=2;
count=&_trt2;
output;
_trt=3;
count=&_trt3;
output;
run;*----------------------------------------------------------------------;
* Create _DENOMF a frame dataset for the denominators ;*----------------------------------------------------------------------;
FDA-CBER-2022-5812-0072637
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]data _denomf3;
_datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
_trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;
*----------------------------------------------------------------------;
* Transpose _DENOM into _DENOMIN to get COUNT as _TRTn columns ;*----------------------------------------------------------------------;
proc sql noprint;
select put(nobs - delobs, 12.) into :_nobs from dictionary.tables
where (libname="WORK" and memname="_DENOM3");
select setting into :miss from dictionary.options where
upcase(optname)="MISSING";
quit;proc transpose data=_denom3 out=_denomin3(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;proc sql noprint;
select put(nobs - delobs, 12.) into :_nobs from dictionary.tables
where (libname="WORK" and memname="_PCT3");
select setting into :miss from dictionary.options where
upcase(optname)="MISSING";
quit;;proc sort data=_pct3 out=_expv3 (keep=_datasrt _blcksrt NEWRACE) nodupkey;
by _datasrt _blcksrt NEWRACE;
run;proc sql noprint;
select put(nobs - delobs, 12.) into :_nobs from dictionary.tables
where (libname="WORK" and memname="_PCT3");
select setting into :miss from dictionary.options where
upcase(optname)="MISSING";
quit;;proc sort data=_expv3;
by _datasrt _blcksrt NEWRACE;
run;
FDA-CBER-2022-5812-0072638
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]data _frame3;
set _expv3;
by _datasrt _blcksrt NEWRACE;
if first._blcksrt then
_catord=0;
_catord + 1;
_trt=1;
_cat=1;
output;
_trt=2;
_cat=1;
output;
_trt=3;
_cat=1;
output;
run;
proc sort data=_frame3;
by _datasrt _blcksrt _cat NEWRACE _trt;
run;proc sort data=_pct3;
by _datasrt _blcksrt _cat NEWRACE _trt;
run;data _pct3;
merge _frame3(in=_inframe) _pct3;
by _datasrt _blcksrt _cat NEWRACE _trt;
if _inframe;
if count=. then
count=0;
run;*----------------------------------------------------------------------;
* Delete Zero filled MISSING category rows for each combination of;* _datasrt &_byvar _blcksrt;*----------------------------------------------------------------------;
proc sort data=_pct3;
by _datasrt _blcksrt NEWRACE;
run;data _miss3(keep=_datasrt _blcksrt NEWRACE totcount);
set _pct3;
where NEWRACE='ZZZY';
retain totcount;
by _datasrt _blcksrt NEWRACE;
if first.NEWRACE then
totcount=0;
FDA-CBER-2022-5812-0072639
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] totcount=totcount+count;
if last.NEWRACE;
run;
data _pct3(drop=totcount);
merge _pct3 _miss3;
by _datasrt _blcksrt NEWRACE;
if totcount=0 then
delete;
run;*******************************************************************;
*IF PCTDISP=CAT/DPTVAR then add dptvar into denomitor frame dataset;*******************************************************************;*----------------------------------------------------------------------;* Merge the _DENOMIN with its frame up dataset (_denomf) ;*----------------------------------------------------------------------;
proc sort data=_denomf3;
by _datasrt _cat;
run;proc sort data=_denomin3;
by _datasrt _cat;
run;data _denomin3;
merge _denomf3(in=_inframe) _denomin3;
by _datasrt _cat;
if _inframe;
_blcksrt=2;
run;*----------------------------------------------------------------------;
* Merge in _PCT(counts) with the _DENOMIN(denominator for percents) ;*----------------------------------------------------------------------;
proc sort data=_pct3;
by _datasrt _cat;
run;*----------------------------------------------------------------------;
* Create _VARNAME variable to hold depend variable name. ;* Create _VRLABEL variable to display Group label. ;* Create _RWLABEL variable to display &dptvar categories. ;*----------------------------------------------------------------------;
data _pct3;
if 0 then
set _basetemplate;
merge _denomin3(in=_a) _pct3;
FDA-CBER-2022-5812-0072640
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] by _datasrt _cat;
if _a;
_varname="NEWRACE ";
_vrlabel="Race ";
_rwlabel="All others ";
if NEWRACE='ZZZY' then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if NEWRACE='ZZZZ' then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct3;
by _datasrt _blcksrt _catord NEWRACE _trt _cat;
run;*----------------------------------------------------------------------;
* Create _CVALUE variable to display results. ;* Create _ROWSRT variable to order results. ;*----------------------------------------------------------------------;
data _base3;
length _catlabl $200;
set _pct3 end=eof;
by _datasrt _blcksrt _catord NEWRACE _trt _cat;
retain _rowsrt 2 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
_cpct=' ';
_module='mcatstat';
if count > . then
_cvalue=put(count, 5.);
else
_cvalue=put(0, 5.);
*----------------------------------------------------------------------;
* Format percent to append to display value in _CVALUE ;
*----------------------------------------------------------------------;
if _trt ne . then
do;
if _trtcnt(_trt) > 0 then
FDA-CBER-2022-5812-0072641
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] do;
percent=count / _trtcnt(_trt) * 100;
if percent > 0 then
do;
if round(percent, 0.1) GE 0.1 then
_cpct="(*ESC*){nbspace 1}("||strip(put(percent, 5.1))||")";
else
_cpct="(*ESC*){nbspace 1}(0.0)";
_cvalue=trim(_cvalue)||_cpct;
end;
end;
end;
/* if length(_cvalue) < 13 then do; */
*----------------------------------------------------------------------;
* Put character A0x at right most character to pad text;
*----------------------------------------------------------------------;
/* substr(_cvalue,13,1)= 'A0'x ; */
/* end; */
if first.NEWRACE then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=3;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
data _anal4;
length ARACEN 8;
set _data1;
where same and ARACEN is not missing;
_blcksrt=2;
_cnt=1;
_cat=1;
FDA-CBER-2022-5812-0072642
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] if _trt <=0 then
delete;
output;
run;
proc sort data=_anal4;
by _datasrt _blcksrt ARACEN _trt _cat;
run;*--- Counts for each by-sequence, dependant var, and treatment combination ---*;data _temp4;
set _anal4;
output;
run;proc sort data=_temp4 out=_temp94 nodupkey;
by _datasrt _blcksrt _cat ARACEN _trt USUBJID;
;
run;proc freq data=_temp94;
format ARACEN;
tables _datasrt*_blcksrt*_cat * ARACEN * _trt / sparse norow nocol nopercent
out=_pct4(drop=percent);
run;proc sort data=_anal4 out=_denom4(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom4;
set _denom4;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1;
output;
_trt=2;
count=&_trt2;
;
output;
_trt=3;
count=&_trt3;
output;
run;*----------------------------------------------------------------------;
* Create _DENOMF a frame dataset for the denominators ;*----------------------------------------------------------------------;
data _denomf4;
FDA-CBER-2022-5812-0072643
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] _datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
_trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;
*----------------------------------------------------------------------;
* Transpose _DENOM into _DENOMIN to get COUNT as _TRTn columns ;*----------------------------------------------------------------------;
proc sql noprint;
select put(nobs - delobs, 12.) into :_nobs from dictionary.tables
where (libname="WORK" and memname="_DENOM4");
select setting into :miss from dictionary.options where
upcase(optname)="MISSING";
quit;;proc transpose data=_denom4 out=_denomin4(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;*----------------------------------------------------------------------;
* Create _FRAME dataset using all combinations of category variable ;*----------------------------------------------------------------------;
data _frame4;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=2;
length ARACEN 8;
_catLabl=" ";
_trt=1;
ARACEN=3;
_catord=1;
_cat=1;
output;
_trt=2;
ARACEN=3;
_catord=1;
_cat=1;
output;
_trt=3;
ARACEN=3;
_catord=1;
_cat=1;
FDA-CBER-2022-5812-0072644
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] output;
_catLabl=" ";
_trt=1;
ARACEN=4;
_catord=2;
_cat=1;
output;
_trt=2;
ARACEN=4;
_catord=2;
_cat=1;
output;
_trt=3;
ARACEN=4;
_catord=2;
_cat=1;
output;
_catLabl=" ";
_trt=1;
ARACEN=5;
_catord=3;
_cat=1;
output;
_trt=2;
ARACEN=5;
_catord=3;
_cat=1;
output;
_trt=3;
ARACEN=5;
_catord=3;
_cat=1;
output;
_catLabl=" ";
_trt=1;
ARACEN=6;
_catord=4;
_cat=1;
output;
_trt=2;
ARACEN=6;
_catord=4;
_cat=1;
output;
_trt=3;
ARACEN=6;
_catord=4;
_cat=1;
output;
_catLabl=" ";
_trt=1;
ARACEN=7;
_catord=5;
_cat=1;
FDA-CBER-2022-5812-0072645
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] output;
_trt=2;
ARACEN=7;
_catord=5;
_cat=1;
output;
_trt=3;
ARACEN=7;
_catord=5;
_cat=1;
output;
_catLabl=" ";
_trt=1;
ARACEN=8;
_catord=6;
_cat=1;
output;
_trt=2;
ARACEN=8;
_catord=6;
_cat=1;
output;
_trt=3;
ARACEN=8;
_catord=6;
_cat=1;
output;
run;
*----------------------------------------------------------------------;
* Merge the _PCT dataset with its frameup dataset(_FRAME) ;*----------------------------------------------------------------------;
proc sort data=_frame4;
by _datasrt _blcksrt _cat ARACEN _trt;
run;proc sort data=_pct4;
by _datasrt _blcksrt _cat ARACEN _trt;
run;data _pct4;
merge _frame4(in=_inframe) _pct4;
by _datasrt _blcksrt _cat ARACEN _trt;
if _inframe;
if count=. then
count=0;
run;*----------------------------------------------------------------------;
* Delete Zero filled MISSING category rows for each combination of;
* _datasrt &_byvar _blcksrt;
FDA-CBER-2022-5812-0072646
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]*----------------------------------------------------------------------;
proc sort data=_pct4;
by _datasrt _blcksrt ARACEN;
run;
data _miss4(keep=_datasrt _blcksrt ARACEN totcount);
set _pct4;
where ARACEN=9998;
retain totcount;
by _datasrt _blcksrt ARACEN;
if first.ARACEN then
totcount=0;
totcount=totcount+count;
if last.ARACEN;
run;data _pct4(drop=totcount);
merge _pct4 _miss4;
by _datasrt _blcksrt ARACEN;
if totcount=0 then
delete;
run;*******************************************************************;
*IF PCTDISP=CAT/DPTVAR then add dptvar into denomitor frame dataset;*******************************************************************;*----------------------------------------------------------------------;* Merge the _DENOMIN with its frame up dataset (_denomf) ;*----------------------------------------------------------------------;
proc sort data=_denomf4;
by _datasrt _cat;
run;proc sort data=_denomin4;
by _datasrt _cat;
run;data _denomin4;
merge _denomf4(in=_inframe) _denomin4;
by _datasrt _cat;
if _inframe;
_blcksrt=2;
run;*----------------------------------------------------------------------;
* Merge in _PCT(counts) with the _DENOMIN(denominator for percents) ;*----------------------------------------------------------------------;
FDA-CBER-2022-5812-0072647
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]proc sort data=_pct4;
by _datasrt _cat;
run;
*----------------------------------------------------------------------;
* Create _VARNAME variable to hold depend variable name. ;* Create _VRLABEL variable to display Group label. ;* Create _RWLABEL variable to display &dptvar categories. ;*----------------------------------------------------------------------;
data _pct4;
if 0 then
set _basetemplate;
merge _denomin4(in=_a) _pct4;
by _datasrt _cat;
if _a;
_varname="ARACEN ";
_vrlabel="Race ";
_rwlabel=put(ARACEN, arace.);
if ARACEN=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if ARACEN=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct4;
by _datasrt _blcksrt _catord ARACEN _trt _cat;
run;*----------------------------------------------------------------------;
* Create _CVALUE variable to display results. ;* Create _ROWSRT variable to order results. ;*----------------------------------------------------------------------;
data _base4;
length _catlabl $200;
set _pct4 end=eof;
by _datasrt _blcksrt _catord ARACEN _trt _cat;
retain _rowsrt 3 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
_cpct=' ';
FDA-CBER-2022-5812-0072648
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] _module='mcatstat';
if count > . then
_cvalue=put(count, 5.);
else
_cvalue=put(0, 5.);
*----------------------------------------------------------------------;
* Format percent to append to display value in _CVALUE ;
*----------------------------------------------------------------------;
if _trt ne . then
do;
if _trtcnt(_trt) > 0 then
do;
percent=count / _trtcnt(_trt) * 100;
if percent > 0 then
do;
if round(percent, 0.1) GE 0.1 then
_cpct="(*ESC*){nbspace 1}("||strip(put(percent, 5.1))||")";
else
_cpct="(*ESC*){nbspace 1}(0.0)";
_cvalue=trim(_cvalue)||_cpct;
end;
end;
end;
/* if length(_cvalue) < 13 then do; */
*----------------------------------------------------------------------;
* Put character A0x at right most character to pad text;
*----------------------------------------------------------------------;
/* substr(_cvalue,13,1)= 'A0'x ; */
/* end; */
if first.ARACEN then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=6;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
FDA-CBER-2022-5812-0072649
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
proc sql;
create table nozero as select * , sum(count) as sum from _base4 group by
_rwlabel having sum>0;
quit;data _base4;
set nozero;
run;********************************************************************************;
*SPECIFICATION 5 -1) RACIALD - n and percent when RACIALD exists *;********************************************************************************;
data _anal5;
length RACIALDN 8;
set _data1;
where same and RACIALDN is not missing;
_blcksrt=3;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;proc sort data=_anal5;
by _datasrt _blcksrt RACIALDN _trt _cat;
run;*--- Counts for each by-sequence, dependant var, and treatment combination ---*;data _temp5;
set _anal5;
output;
run;proc sort data=_temp5 out=_temp95 nodupkey;
by _datasrt _blcksrt _cat RACIALDN _trt USUBJID;
;
run;proc freq data=_temp95;
format RACIALDN;
tables _datasrt*_blcksrt*_cat * RACIALDN * _trt / sparse norow nocol nopercent
out=_pct5(drop=percent);
run;
FDA-CBER-2022-5812-0072650
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]proc sort data=_anal5 out=_denom5(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;
data _denom5;
set _denom5;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1;
output;
_trt=2;
count=&_trt2;
output;
_trt=3;
count=&_trt3;
output;
run;*----------------------------------------------------------------------;
* Create _DENOMF a frame dataset for the denominators ;*----------------------------------------------------------------------;
data _denomf5;
_datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
_trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;proc sql noprint;
select put(nobs - delobs, 12.) into :_nobs from dictionary.tables
where (libname="WORK" and memname="_DENOM5");
select setting into :miss from dictionary.options where
upcase(optname)="MISSING";
quit;;proc transpose data=_denom5 out=_denomin5(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;*----------------------------------------------------------------------;
* VALRANGE=FULL. Create full rank categories WITHOUT using where. ;
FDA-CBER-2022-5812-0072651
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]*----------------------------------------------------------------------;
proc sql noprint;
select count(distinct RACIALDN) into : totexpv from _anal5;
select distinct RACIALDN into :expv1 - :expv1 from _anal5 order by RACIALDN;
quit;
*----------------------------------------------------------------------;
* Create _FRAME dataset using all combinations of category variable ;*----------------------------------------------------------------------;
data _frame5;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=3;
length RACIALDN 8;
_catLabl=" ";
_trt=1;
RACIALDN=5;
_catord=1;
_cat=1;
output;
_trt=2;
RACIALDN=5;
_catord=1;
_cat=1;
output;
_trt=3;
RACIALDN=5;
_catord=1;
_cat=1;
output;
run;*----------------------------------------------------------------------;
* Merge the _PCT dataset with its frameup dataset(_FRAME) ;*----------------------------------------------------------------------;
proc sort data=_frame5;
by _datasrt _blcksrt _cat RACIALDN _trt;
run;proc sort data=_pct5;
by _datasrt _blcksrt _cat RACIALDN _trt;
run;data _pct5;
merge _frame5(in=_inframe) _pct5;
by _datasrt _blcksrt _cat RACIALDN _trt;
if _inframe;
if count=. then
count=0;
FDA-CBER-2022-5812-0072652
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]run;
*----------------------------------------------------------------------;
* Delete Zero filled MISSING category rows for each combination of;* _datasrt &_byvar _blcksrt;*----------------------------------------------------------------------;
proc sort data=_pct5;
by _datasrt _blcksrt RACIALDN;
run;data _miss5(keep=_datasrt _blcksrt RACIALDN totcount);
set _pct5;
where RACIALDN=9998;
retain totcount;
by _datasrt _blcksrt RACIALDN;
if first.RACIALDN then
totcount=0;
totcount=totcount+count;
if last.RACIALDN;
run;data _pct5(drop=totcount);
merge _pct5 _miss5;
by _datasrt _blcksrt RACIALDN;
if totcount=0 then
delete;
run;proc sort data=_denomf5;
by _datasrt _cat;
run;proc sort data=_denomin5;
by _datasrt _cat;
run;data _denomin5;
merge _denomf5(in=_inframe) _denomin5;
by _datasrt _cat;
if _inframe;
_blcksrt=3;
run;proc sort data=_pct5;
by _datasrt _cat;
run;data _pct5;
if 0 then
FDA-CBER-2022-5812-0072653
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] set _basetemplate;
merge _denomin5(in=_a) _pct5;
by _datasrt _cat;
if _a;
_varname="RACIALDN ";
_vrlabel="Racial designation ";
_rwlabel=put(RACIALDN, raciald.);
if RACIALDN=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if RACIALDN=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct5;
by _datasrt _blcksrt _catord RACIALDN _trt _cat;
run;*----------------------------------------------------------------------;
* Create _CVALUE variable to display results. ;* Create _ROWSRT variable to order results. ;*----------------------------------------------------------------------;
data _base5;
length _catlabl $200;
set _pct5 end=eof;
by _datasrt _blcksrt _catord RACIALDN _trt _cat;
retain _rowsrt 0 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
_cpct=' ';
_module='mcatstat';
if count > . then
_cvalue=put(count, 5.);
else
_cvalue=put(0, 5.);
*----------------------------------------------------------------------;
* Format percent to append to display value in _CVALUE ;
*----------------------------------------------------------------------;
if _trt ne . then
do;
FDA-CBER-2022-5812-0072654
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] if _trtcnt(_trt) > 0 then
do;
percent=count / _trtcnt(_trt) * 100;
if percent > 0 then
do;
if round(percent, 0.1) GE 0.1 then
_cpct="(*ESC*){nbspace 1}("||strip(put(percent, 5.1))||")";
else
_cpct="(*ESC*){nbspace 1}(0.0)";
_cvalue=trim(_cvalue)||_cpct;
end;
end;
end;
if length(_cvalue) < 13 then
do;
*----------------------------------------------------------------------;
* Put character A0x at right most character to pad text;
*----------------------------------------------------------------------;
substr(_cvalue, 13, 1)='A0'x;
end;
if first.RACIALDN then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=3;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
data _anal6;
length ETHNICN 8;
set _data1;
where same and ETHNICN is not missing;
FDA-CBER-2022-5812-0072655
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] _blcksrt=4;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal6;
by _datasrt _blcksrt ETHNICN _trt _cat;
run;*--- Counts for each by-sequence, dependant var, and treatment combination ---*;data _temp6;
set _anal6;
output;
run;proc sort data=_temp6 out=_temp96 nodupkey;
by _datasrt _blcksrt _cat ETHNICN _trt USUBJID;
;
run;proc freq data=_temp96;
format ETHNICN;
tables _datasrt*_blcksrt*_cat * ETHNICN * _trt / sparse norow nocol nopercent
out=_pct6(drop=percent);
run;proc sort data=_anal6 out=_denom6(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom6;
set _denom6;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1;
output;
_trt=2;
count=&_trt2;
output;
_trt=3;
count=&_trt3;
output;
run;*----------------------------------------------------------------------;
* Create _DENOMF a frame dataset for the denominators ;
*----------------------------------------------------------------------;
FDA-CBER-2022-5812-0072656
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]data _denomf6;
_datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
_trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;
*----------------------------------------------------------------------;
* Transpose _DENOM into _DENOMIN to get COUNT as _TRTn columns ;*----------------------------------------------------------------------;
proc sql noprint;
select put(nobs - delobs, 12.) into :_nobs from dictionary.tables
where (libname="WORK" and memname="_DENOM6");
select setting into :miss from dictionary.options where
upcase(optname)="MISSING";
quit;;proc transpose data=_denom6 out=_denomin6(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;*----------------------------------------------------------------------;
* VALRANGE=FULL. Create full rank categories WITHOUT using where. ;*----------------------------------------------------------------------;
proc sql noprint;
select count(distinct ETHNICN) into : totexpv from _anal6;
select distinct ETHNICN into :expv1 - :expv3 from _anal6 order by ETHNICN;
quit;*----------------------------------------------------------------------;
* Create _FRAME dataset using all combinations of category variable ;*----------------------------------------------------------------------;
data _frame6;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=4;
length ETHNICN 8;
_catLabl=" ";
_trt=1;
ETHNICN=1;
_catord=1;
FDA-CBER-2022-5812-0072657
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] _cat=1;
output;
_trt=2;
ETHNICN=1;
_catord=1;
_cat=1;
output;
_trt=3;
ETHNICN=1;
_catord=1;
_cat=1;
output;
_catLabl=" ";
_trt=1;
ETHNICN=2;
_catord=2;
_cat=1;
output;
_trt=2;
ETHNICN=2;
_catord=2;
_cat=1;
output;
_trt=3;
ETHNICN=2;
_catord=2;
_cat=1;
output;
_catLabl=" ";
_trt=1;
ETHNICN=3;
_catord=3;
_cat=1;
output;
_trt=2;
ETHNICN=3;
_catord=3;
_cat=1;
output;
_trt=3;
ETHNICN=3;
_catord=3;
_cat=1;
output;
run;
*----------------------------------------------------------------------;
* Merge the _PCT dataset with its frameup dataset(_FRAME) ;*----------------------------------------------------------------------;
proc sort data=_frame6;
by _datasrt _blcksrt _cat ETHNICN _trt;
run;
FDA-CBER-2022-5812-0072658
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]proc sort data=_pct6;
by _datasrt _blcksrt _cat ETHNICN _trt;
run;
data _pct6;
merge _frame6(in=_inframe) _pct6;
by _datasrt _blcksrt _cat ETHNICN _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct6;
by _datasrt _blcksrt ETHNICN;
run;data _miss6(keep=_datasrt _blcksrt ETHNICN totcount);
set _pct6;
where ETHNICN=9998;
retain totcount;
by _datasrt _blcksrt ETHNICN;
if first.ETHNICN then
totcount=0;
totcount=totcount+count;
if last.ETHNICN;
run;data _pct6(drop=totcount);
merge _pct6 _miss6;
by _datasrt _blcksrt ETHNICN;
if totcount=0 then
delete;
run;proc sort data=_denomf6;
by _datasrt _cat;
run;proc sort data=_denomin6;
by _datasrt _cat;
run;data _denomin6;
merge _denomf6(in=_inframe) _denomin6;
by _datasrt _cat;
if _inframe;
_blcksrt=4;
run;
FDA-CBER-2022-5812-0072659
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]proc sort data=_pct6;
by _datasrt _cat;
run;
data _pct6;
if 0 then
set _basetemplate;
merge _denomin6(in=_a) _pct6;
by _datasrt _cat;
if _a;
_varname="ETHNICN ";
_vrlabel="Ethnicity ";
_rwlabel=put(ETHNICN, ethnic.);
if ETHNICN=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if ETHNICN=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct6;
by _datasrt _blcksrt _catord ETHNICN _trt _cat;
run;*----------------------------------------------------------------------;
* Create _CVALUE variable to display results. ;* Create _ROWSRT variable to order results. ;*----------------------------------------------------------------------;
data _base6;
length _catlabl $200;
set _pct6 end=eof;
by _datasrt _blcksrt _catord ETHNICN _trt _cat;
retain _rowsrt 0 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
_cpct=' ';
_module='mcatstat';
if count > . then
_cvalue=put(count, 5.);
else
FDA-CBER-2022-5812-0072660
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] _cvalue=put(0, 5.);
*----------------------------------------------------------------------;
* Format percent to append to display value in _CVALUE ;
*----------------------------------------------------------------------;
if _trt ne . then
do;
if _trtcnt(_trt) > 0 then
do;
percent=count / _trtcnt(_trt) * 100;
if percent > 0 then
do;
if round(percent, 0.1) GE 0.1 then
_cpct="(*ESC*){nbspace 1}("||strip(put(percent, 5.1))||")";
else
_cpct="(*ESC*){nbspace 1}(0.0)";
_cvalue=trim(_cvalue)||_cpct;
end;
end;
end;
/* if length(_cvalue) < 13 then do; */
/*
*----------------------------------------------------------------------; */
/*
* Put character A0x at right most character to pad text; */
/*
*----------------------------------------------------------------------; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first.ETHNICN then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=3;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
FDA-CBER-2022-5812-0072661
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]data _anal7;
length COUNTRYX $50;
set _data1;
where same and COUNTRYX is not missing;
_blcksrt=5;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal7;
by _datasrt _blcksrt COUNTRYX _trt _cat;
run;*--- Counts for each by-sequence, dependant var, and treatment combination ---*;data _temp7;
set _anal7;
output;
run;proc sort data=_temp7 out=_temp97 nodupkey;
by _datasrt _blcksrt _cat COUNTRYX _trt USUBJID;
run;proc freq data=_temp97;
format COUNTRYX;
tables _datasrt*_blcksrt*_cat * COUNTRYX * _trt / sparse norow nocol nopercent
out=_pct7(drop=percent);
run;proc sort data=_anal7 out=_denom7(keep=_datasrt _cat) nodupkey;
by _datasrt _cat;
run;data _denom7;
set _denom7;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1;
output;
_trt=2;
count=&_trt2;
output;
_trt=3;
count=&_trt3;
output;
run;
FDA-CBER-2022-5812-0072662
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]*----------------------------------------------------------------------;
* Create _DENOMF a frame dataset for the denominators ;
*----------------------------------------------------------------------;
data _denomf7;
_datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
_trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;*----------------------------------------------------------------------;
* Transpose _DENOM into _DENOMIN to get COUNT as _TRTn columns ;*----------------------------------------------------------------------;
proc sql noprint;
select put(nobs - delobs, 12.) into :_nobs from dictionary.tables
where (libname="WORK" and memname="_DENOM7");
select setting into :miss from dictionary.options where
upcase(optname)="MISSING";
quit;proc transpose data=_denom7 out=_denomin7(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;proc sql noprint;
select put(nobs - delobs, 12.) into :_nobs from dictionary.tables
where (libname="WORK" and memname="_PCT7");
select setting into :miss from dictionary.options where
upcase(optname)="MISSING";
quit;proc sort data=_pct7 out=_expv7 (keep=_datasrt _blcksrt COUNTRYX) nodupkey;
by _datasrt _blcksrt COUNTRYX;
run;proc sql noprint;
select put(nobs - delobs, 12.) into :_nobs from dictionary.tables
where (libname="WORK" and memname="_PCT7");
select setting into :miss from dictionary.options where
upcase(optname)="MISSING";
quit;proc sort data=_expv7;
by _datasrt _blcksrt COUNTRYX;
run;
FDA-CBER-2022-5812-0072663
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]data _frame7;
set _expv7;
by _datasrt _blcksrt COUNTRYX;
if first._blcksrt then
_catord=0;
_catord + 1;
_trt=1;
_cat=1;
output;
_trt=2;
_cat=1;
output;
_trt=3;
_cat=1;
output;
run;
*----------------------------------------------------------------------;
* Merge the _PCT dataset with its frameup dataset(_FRAME) ;*----------------------------------------------------------------------;
proc sort data=_frame7;
by _datasrt _blcksrt _cat COUNTRYX _trt;
run;proc sort data=_pct7;
by _datasrt _blcksrt _cat COUNTRYX _trt;
run;data _pct7;
merge _frame7(in=_inframe) _pct7;
by _datasrt _blcksrt _cat COUNTRYX _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct7;
by _datasrt _blcksrt COUNTRYX;
run;data _miss7(keep=_datasrt _blcksrt COUNTRYX totcount);
set _pct7;
where COUNTRYX='ZZZY';
retain totcount;
by _datasrt _blcksrt COUNTRYX;
if first.COUNTRYX then
totcount=0;
totcount=totcount+count;
FDA-CBER-2022-5812-0072664
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] if last.COUNTRYX;
run;
data _pct7(drop=totcount);
merge _pct7 _miss7;
by _datasrt _blcksrt COUNTRYX;
if totcount=0 then
delete;
run;proc sort data=_denomf7;
by _datasrt _cat;
run;proc sort data=_denomin7;
by _datasrt _cat;
run;data _denomin7;
merge _denomf7(in=_inframe) _denomin7;
by _datasrt _cat;
if _inframe;
_blcksrt=5;
run;proc sort data=_pct7;
by _datasrt _cat;
run;data _pct7;
if 0 then
set _basetemplate;
merge _denomin7(in=_a) _pct7;
by _datasrt _cat;
if _a;
_varname="COUNTRYX ";
_vrlabel="Country ";
_rwlabel=COUNTRYX;
if COUNTRYX='ZZZY' then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if COUNTRYX='ZZZZ' then
do;
_rwlabel="Total ";
_catord=9999;
end;
FDA-CBER-2022-5812-0072665
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] if _catord=. then
_catord=9997;
run;
proc sort data=_pct7;
by _datasrt _blcksrt _catord COUNTRYX _trt _cat;
run;*----------------------------------------------------------------------;
* Create _CVALUE variable to display results. ;* Create _ROWSRT variable to order results. ;*----------------------------------------------------------------------;
data _base7;
length _catlabl $200;
set _pct7 end=eof;
by _datasrt _blcksrt _catord COUNTRYX _trt _cat;
retain _rowsrt 0 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
_cpct=' ';
_module='mcatstat';
if count > . then
_cvalue=put(count, 5.);
else
_cvalue=put(0, 5.);
*----------------------------------------------------------------------;
* Format percent to append to display value in _CVALUE ;
*----------------------------------------------------------------------;
if _trt ne . then
do;
if _trtcnt(_trt) > 0 then
do;
percent=count / _trtcnt(_trt) * 100;
if percent > 0 then
do;
if round(percent, 0.1) GE 0.1 then
_cpct="(*ESC*){nbspace 1}("||strip(put(percent, 5.1))||")";
else
_cpct="(*ESC*){nbspace 1}(0.0)";
_cvalue=trim(_cvalue)||_cpct;
end;
end;
end;
if length(_cvalue) < 13 then
do;
*----------------------------------------------------------------------;
FDA-CBER-2022-5812-0072666
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] * Put character A0x at right most character to pad text;
*----------------------------------------------------------------------;
substr(_cvalue, 13, 1)='A0'x;
end;
if first.COUNTRYX then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=3;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
data _anal8;
length COVBLSTN 8;
set _data1;
if COVBLSTN=. then
COVBLSTN=9998;
_blcksrt=6;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;proc sort data=_anal8;
by _datasrt _blcksrt COVBLSTN _trt _cat;
run;*--- Counts for each by-sequence, dependant var, and treatment combination ---*;data _temp8;
set _anal8;
output;
FDA-CBER-2022-5812-0072667
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]run;
proc sort data=_temp8 out=_temp98 nodupkey;
by _datasrt _blcksrt _cat COVBLSTN _trt USUBJID;
run;
proc freq data=_temp98;
format COVBLSTN;
tables _datasrt*_blcksrt*_cat * COVBLSTN * _trt / sparse norow nocol nopercent
out=_pct8(drop=percent);
run;proc sort data=_anal8 out=_denom8(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom8;
set _denom8;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1;
output;
_trt=2;
count=&_trt2;
output;
_trt=3;
count=&_trt3;
output;
run;*----------------------------------------------------------------------;
* Create _DENOMF a frame dataset for the denominators ;*----------------------------------------------------------------------;
data _denomf8;
_datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
_trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;*----------------------------------------------------------------------;
* Transpose _DENOM into _DENOMIN to get COUNT as _TRTn columns ;*----------------------------------------------------------------------;
proc sql noprint;
select put(nobs - delobs, 12.) into :_nobs from dictionary.tables
FDA-CBER-2022-5812-0072668
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] where (libname="WORK" and memname="_DENOM8");
select setting into :miss from dictionary.options where
upcase(optname)="MISSING";
quit;
proc transpose data=_denom8 out=_denomin8(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;*----------------------------------------------------------------------;
* VALRANGE=FULL. Create full rank categories WITHOUT using where. ;*----------------------------------------------------------------------;
proc sql noprint;
select count(distinct COVBLSTN) into : totexpv from _anal8;
select distinct COVBLSTN into :expv1 - :expv3 from _anal8 order by COVBLSTN;
quit;*----------------------------------------------------------------------;
* Create _FRAME dataset using all combinations of category variable ;*----------------------------------------------------------------------;
data _frame8;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=6;
length COVBLSTN 8;
_catLabl=" ";
_trt=1;
COVBLSTN=1;
_catord=1;
_cat=1;
output;
_trt=2;
COVBLSTN=1;
_catord=1;
_cat=1;
output;
_trt=3;
COVBLSTN=1;
_catord=1;
_cat=1;
output;
_catLabl=" ";
_trt=1;
COVBLSTN=2;
_catord=2;
_cat=1;
output;
_trt=2;
COVBLSTN=2;
_catord=2;
FDA-CBER-2022-5812-0072669
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] _cat=1;
output;
_trt=3;
COVBLSTN=2;
_catord=2;
_cat=1;
output;
_catLabl=" ";
_trt=1;
COVBLSTN=999;
_catord=3;
_cat=1;
output;
_trt=2;
COVBLSTN=999;
_catord=3;
_cat=1;
output;
_trt=3;
COVBLSTN=999;
_catord=3;
_cat=1;
output;
run;
*----------------------------------------------------------------------;
* Merge the _PCT dataset with its frameup dataset(_FRAME) ;*----------------------------------------------------------------------;
proc sort data=_frame8;
by _datasrt _blcksrt _cat COVBLSTN _trt;
run;proc sort data=_pct8;
by _datasrt _blcksrt _cat COVBLSTN _trt;
run;data _pct8;
merge _frame8(in=_inframe) _pct8;
by _datasrt _blcksrt _cat COVBLSTN _trt;
if _inframe;
if count=. then
count=0;
run;*----------------------------------------------------------------------;
* Delete Zero filled MISSING category rows for each combination of;* _datasrt &_byvar _blcksrt;*----------------------------------------------------------------------;
proc sort data=_pct8;
by _datasrt _blcksrt COVBLSTN;
FDA-CBER-2022-5812-0072670
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]run;
data _miss8(keep=_datasrt _blcksrt COVBLSTN totcount);
set _pct8;
where COVBLSTN=9998;
retain totcount;
by _datasrt _blcksrt COVBLSTN;
if first.COVBLSTN then
totcount=0;
totcount=totcount+count;
if last.COVBLSTN;
run;
data _pct8(drop=totcount);
merge _pct8 _miss8;
by _datasrt _blcksrt COVBLSTN;
if totcount=0 then
delete;
run;*******************************************************************;
*IF PCTDISP=CAT/DPTVAR then add dptvar into denomitor frame dataset;*******************************************************************;*----------------------------------------------------------------------;* Merge the _DENOMIN with its frame up dataset (_denomf) ;*----------------------------------------------------------------------;
proc sort data=_denomf8;
by _datasrt _cat;
run;proc sort data=_denomin8;
by _datasrt _cat;
run;data _denomin8;
merge _denomf8(in=_inframe) _denomin8;
by _datasrt _cat;
if _inframe;
_blcksrt=6;
run;proc sort data=_pct8;
by _datasrt _cat;run;
data _pct8;
if 0 then set _basetemplate;
merge _denomin8(in=_a) _pct8;
FDA-CBER-2022-5812-0072671
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] by _datasrt _cat;
if _a;
_varname="COVBLSTN "; _vrlabel="Baseline SARS-CoV-2 status "; _rwlabel=put(COVBLSTN, sars.);
if COVBLSTN=9998 then
do; _rwlabel="Missing "; _catord=9998; end; else if COVBLSTN=9999 then do; _rwlabel="Total "; _catord=9999; end;
if _catord=. then
_catord=9997;run;
proc sort data=_pct8;
by _datasrt _blcksrt _catord COVBLSTN _trt _cat;run;
*----------------------------------------------------------------------;
* Create _CVALUE variable to display results. ;* Create _ROWSRT variable to order results. ;*----------------------------------------------------------------------;
data _base8;
length _catlabl $200; set _pct8 end=eof; by _datasrt _blcksrt _catord COVBLSTN _trt _cat;
retain _rowsrt 0 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
_cpct=' ';
_module='mcatstat';
if count > . then
_cvalue=put(count, 5.);
else
_cvalue=put(0, 5.);
*----------------------------------------------------------------------;
* Format percent to append to display value in _CVALUE ;
*----------------------------------------------------------------------;
if _trt ne . then
do;
if _trtcnt(_trt) > 0 then
FDA-CBER-2022-5812-0072672
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] do;
percent=count / _trtcnt(_trt) * 100;
if percent > 0 then
do;
if round(percent, 0.1) GE 0.1 then
_cpct="(*ESC*){nbspace 1}("||strip(put(percent, 5.1))||")";
else
_cpct="(*ESC*){nbspace 1}(0.0)";
_cvalue=trim(_cvalue)||_cpct;
end;
end;
end;
if length(_cvalue) < 13 then
do;
*----------------------------------------------------------------------;
* Put character A0x at right most character to pad text;
*----------------------------------------------------------------------;
substr(_cvalue, 13, 1)='A0'x;
end;
if first.COVBLSTN then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=3;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
data _anal9;
length COMBODFLNX 8;
set _data1;
if COMBODFLNX=. then
COMBODFLNX=9998;
FDA-CBER-2022-5812-0072673
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] _blcksrt=7;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal9;
by _datasrt _blcksrt COMBODFLNX _trt _cat;
run;*--- Counts for each by-sequence, dependant var, and treatment combination ---*;data _temp9;
set _anal9;
output;
run;proc sort data=_temp9 out=_temp99 nodupkey;
by _datasrt _blcksrt _cat COMBODFLNX _trt USUBJID;
;
run;proc freq data=_temp99;
format COMBODFLNX;
tables _datasrt*_blcksrt*_cat * COMBODFLNX * _trt / sparse norow nocol
nopercent out=_pct9(drop=percent);
run;proc sort data=_anal9 out=_denom9(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom9;
set _denom9;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1;
output;
_trt=2;
count=&_trt2;
output;
_trt=3;
count=&_trt3;
output;
run;*----------------------------------------------------------------------;
* Create _DENOMF a frame dataset for the denominators ;
*----------------------------------------------------------------------;
FDA-CBER-2022-5812-0072674
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]data _denomf9;
_datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
_trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;
*----------------------------------------------------------------------;
* Transpose _DENOM into _DENOMIN to get COUNT as _TRTn columns ;*----------------------------------------------------------------------;
proc sql noprint;
select put(nobs - delobs, 12.) into :_nobs from dictionary.tables
where (libname="WORK" and memname="_DENOM9");
select setting into :miss from dictionary.options where
upcase(optname)="MISSING";
quit;;proc transpose data=_denom9 out=_denomin9(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;*----------------------------------------------------------------------;
* VALRANGE=FULL. Create full rank categories WITHOUT using where. ;*----------------------------------------------------------------------;
proc sql noprint;
select count(distinct COMBODFLNX) into : totexpv from _anal9;
select distinct COMBODFLNX , COMBODFLX into :expv1 - :expv2 ,
:catlab1 - :catlab2 from _anal9 order by COMBODFLNX;
quit;*----------------------------------------------------------------------;
* Create _FRAME dataset using all combinations of category variable ;*----------------------------------------------------------------------;
data _frame9;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=7;
length COMBODFLNX 8;
length _catLabl $7;
_catLabl=' ';
_catLabl="Yes ";
FDA-CBER-2022-5812-0072675
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] _trt=1;
COMBODFLNX=1;
_catord=1;
_cat=1;
output;
_trt=2;
COMBODFLNX=1;
_catord=1;
_cat=1;
output;
_trt=3;
COMBODFLNX=1;
_catord=1;
_cat=1;
output;
_catLabl="No ";
_trt=1;
COMBODFLNX=2;
_catord=2;
_cat=1;
output;
_trt=2;
COMBODFLNX=2;
_catord=2;
_cat=1;
output;
_trt=3;
COMBODFLNX=2;
_catord=2;
_cat=1;
output;
run;
*----------------------------------------------------------------------;
* Merge the _PCT dataset with its frameup dataset(_FRAME) ;*----------------------------------------------------------------------;
proc sort data=_frame9;
by _datasrt _blcksrt _cat COMBODFLNX _trt;
run;proc sort data=_pct9;
by _datasrt _blcksrt _cat COMBODFLNX _trt;
run;data _pct9;
merge _frame9(in=_inframe) _pct9;
by _datasrt _blcksrt _cat COMBODFLNX _trt;
if _inframe;
if count=. then
count=0;
run;
FDA-CBER-2022-5812-0072676
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]*----------------------------------------------------------------------;
* Delete Zero filled MISSING category rows for each combination of;* _datasrt &_byvar _blcksrt;*----------------------------------------------------------------------;
proc sort data=_pct9;
by _datasrt _blcksrt COMBODFLNX;
run;data _miss9(keep=_datasrt _blcksrt COMBODFLNX totcount);
set _pct9;
where COMBODFLNX=9998;
retain totcount;
by _datasrt _blcksrt COMBODFLNX;
if first.COMBODFLNX then
totcount=0;
totcount=totcount+count;
if last.COMBODFLNX;
run;data _pct9(drop=totcount);
merge _pct9 _miss9;
by _datasrt _blcksrt COMBODFLNX;
if totcount=0 then
delete;
run;*******************************************************************;
*IF PCTDISP=CAT/DPTVAR then add dptvar into denomitor frame dataset;*******************************************************************;*----------------------------------------------------------------------;* Merge the _DENOMIN with its frame up dataset (_denomf) ;*----------------------------------------------------------------------;
proc sort data=_denomf9;
by _datasrt _cat;
run;proc sort data=_denomin9;
by _datasrt _cat;
run;data _denomin9;
merge _denomf9(in=_inframe) _denomin9;
by _datasrt _cat;
if _inframe;
_blcksrt=7;
run;
FDA-CBER-2022-5812-0072677
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]*----------------------------------------------------------------------;
* Merge in _PCT(counts) with the _DENOMIN(denominator for percents) ;
*----------------------------------------------------------------------;
proc sort data=_pct9;
by _datasrt _cat;
run;*----------------------------------------------------------------------;
* Create _VARNAME variable to hold depend variable name. ;* Create _VRLABEL variable to display Group label. ;* Create _RWLABEL variable to display &dptvar categories. ;*----------------------------------------------------------------------;
data _pct9;
if 0 then
set _basetemplate;
merge _denomin9(in=_a) _pct9;
by _datasrt _cat;
if _a;
_varname="COMBODFLNX ";
_vrlabel="Comorbidities(*ESC*){super e} ";
_rwlabel=_catLabl;
if COMBODFLNX=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if COMBODFLNX=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct9;
by _datasrt _blcksrt _catord COMBODFLNX _trt _cat;
run;*----------------------------------------------------------------------;
* Create _CVALUE variable to display results. ;* Create _ROWSRT variable to order results. ;*----------------------------------------------------------------------;
data _base9;
length _catlabl $200;
set _pct9 end=eof;
by _datasrt _blcksrt _catord COMBODFLNX _trt _cat;
retain _rowsrt 0 _rowmax 0;
FDA-CBER-2022-5812-0072678
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
_cpct=' ';
_module='mcatstat';
if count > . then
_cvalue=put(count, 5.);
else
_cvalue=put(0, 5.);
*----------------------------------------------------------------------;
* Format percent to append to display value in _CVALUE ;
*----------------------------------------------------------------------;
if _trt ne . then
do;
if _trtcnt(_trt) > 0 then
do;
percent=count / _trtcnt(_trt) * 100;
if percent > 0 then
do;
if round(percent, 0.1) GE 0.1 then
_cpct="(*ESC*){nbspace 1}("||strip(put(percent, 5.1))||")";
else
_cpct="(*ESC*){nbspace 1}(0.0)";
_cvalue=trim(_cvalue)||_cpct;
end;
end;
end;
if length(_cvalue) < 13 then
do;
*----------------------------------------------------------------------;
* Put character A0x at right most character to pad text;
*----------------------------------------------------------------------;
substr(_cvalue, 13, 1)='A0'x;
end;
if first.COMBODFLNX then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
FDA-CBER-2022-5812-0072679
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] _indent=3;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
data _anal10;
length OBESEFLN 8;
set _data1;
if OBESEFLN=. then
OBESEFLN=9998;
_blcksrt=8;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;proc sort data=_anal10;
by _datasrt _blcksrt OBESEFLN _trt _cat;
run;*--- Counts for each by-sequence, dependant var, and treatment combination ---*;data _temp10;
set _anal10;
output;
run;proc sort data=_temp10 out=_temp910 nodupkey;
by _datasrt _blcksrt _cat OBESEFLN _trt USUBJID;
;
run;proc freq data=_temp910;
format OBESEFLN;
tables _datasrt*_blcksrt*_cat * OBESEFLN * _trt / sparse norow nocol nopercent
out=_pct10(drop=percent);
run;proc sort data=_anal10 out=_denom10(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;
FDA-CBER-2022-5812-0072680
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]data _denom10;
set _denom10;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1;
output;
_trt=2;
count=&_trt2;
output;
_trt=3;
count=&_trt3;
output;
run;
*----------------------------------------------------------------------;
* Create _DENOMF a frame dataset for the denominators ;*----------------------------------------------------------------------;
data _denomf10;
_datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
_trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;proc transpose data=_denom10 out=_denomin10(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;*----------------------------------------------------------------------;
* VALRANGE=FULL. Create full rank categories WITHOUT using where. ;*----------------------------------------------------------------------;
proc sql noprint;
select count(distinct OBESEFLN) into : totexpv from _anal10;
select distinct OBESEFLN into :expv1 - :expv2 from _anal10 order by OBESEFLN;
quit;*----------------------------------------------------------------------;
* Create _FRAME dataset using all combinations of category variable ;*----------------------------------------------------------------------;
data _frame10;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=8;
FDA-CBER-2022-5812-0072681
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] length OBESEFLN 8;
_catLabl=" ";
_trt=1;
OBESEFLN=1;
_catord=1;
_cat=1;
output;
_trt=2;
OBESEFLN=1;
_catord=1;
_cat=1;
output;
_trt=3;
OBESEFLN=1;
_catord=1;
_cat=1;
output;
_catLabl=" ";
_trt=1;
OBESEFLN=2;
_catord=2;
_cat=1;
output;
_trt=2;
OBESEFLN=2;
_catord=2;
_cat=1;
output;
_trt=3;
OBESEFLN=2;
_catord=2;
_cat=1;
output;
run;
*----------------------------------------------------------------------;
* Merge the _PCT dataset with its frameup dataset(_FRAME) ;*----------------------------------------------------------------------;
proc sort data=_frame10;
by _datasrt _blcksrt _cat OBESEFLN _trt;
run;proc sort data=_pct10;
by _datasrt _blcksrt _cat OBESEFLN _trt;
run;data _pct10;
merge _frame10(in=_inframe) _pct10;
by _datasrt _blcksrt _cat OBESEFLN _trt;
if _inframe;
if count=. then
FDA-CBER-2022-5812-0072682
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] count=0;
run;
*----------------------------------------------------------------------;
* Delete Zero filled MISSING category rows for each combination of;* _datasrt &_byvar _blcksrt;*----------------------------------------------------------------------;
proc sort data=_pct10;
by _datasrt _blcksrt OBESEFLN;
run;data _miss10(keep=_datasrt _blcksrt OBESEFLN totcount);
set _pct10;
where OBESEFLN=9998;
retain totcount;
by _datasrt _blcksrt OBESEFLN;
if first.OBESEFLN then
totcount=0;
totcount=totcount+count;
if last.OBESEFLN;
run;data _pct10(drop=totcount);
merge _pct10 _miss10;
by _datasrt _blcksrt OBESEFLN;
if totcount=0 then
delete;
run;proc sort data=_denomf10;
by _datasrt _cat;
run;proc sort data=_denomin10;
by _datasrt _cat;
run;data _denomin10;
merge _denomf10(in=_inframe) _denomin10;
by _datasrt _cat;
if _inframe;
_blcksrt=8;
run;*----------------------------------------------------------------------;
* Merge in _PCT(counts) with the _DENOMIN(denominator for percents) ;*----------------------------------------------------------------------;
proc sort data=_pct10;
FDA-CBER-2022-5812-0072683
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] by _datasrt _cat;
run;
data _pct10;
if 0 then
set _basetemplate;
merge _denomin10(in=_a) _pct10;
by _datasrt _cat;
if _a;
_varname="OBESEFLN ";
_vrlabel="Obese(*ESC*){super f} ";
_rwlabel=put(OBESEFLN, obes.);
if OBESEFLN=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if OBESEFLN=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct10;
by _datasrt _blcksrt _catord OBESEFLN _trt _cat;
run;*----------------------------------------------------------------------;
* Create _CVALUE variable to display results. ;* Create _ROWSRT variable to order results. ;*----------------------------------------------------------------------;
data _base10;
length _catlabl $200;
set _pct10 end=eof;
by _datasrt _blcksrt _catord OBESEFLN _trt _cat;
retain _rowsrt 0 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
_cpct=' ';
_module='mcatstat';
if count > . then
_cvalue=put(count, 5.);
else
_cvalue=put(0, 5.);
*----------------------------------------------------------------------;
FDA-CBER-2022-5812-0072684
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] * Format percent to append to display value in _CVALUE ;
*----------------------------------------------------------------------;
if _trt ne . then
do;
if _trtcnt(_trt) > 0 then
do;
percent=count / _trtcnt(_trt) * 100;
if percent > 0 then
do;
if round(percent, 0.1) GE 0.1 then
_cpct="(*ESC*){nbspace 1}("||strip(put(percent, 5.1))||")";
else
_cpct="(*ESC*){nbspace 1}(0.0)";
_cvalue=trim(_cvalue)||_cpct;
end;
end;
end;
if length(_cvalue) < 13 then
do;
*----------------------------------------------------------------------;
* Put character A0x at right most character to pad text;
*----------------------------------------------------------------------;
substr(_cvalue, 13, 1)='A0'x;
end;
if first.OBESEFLN then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=3;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
FDA-CBER-2022-5812-0072685
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]data _anal11;
set _data1;
where _trt > 0;
_blcksrt=9;
output;
run;
*----------------------------------------------------------------------;
* Make sure data is sorted by groups ;*----------------------------------------------------------------------;
proc sort data=_anal11;
by _datasrt _blcksrt _trt;
run;*----------------------------------------------------------------------;
* Call PROC UNIVARIATE to generate all possible statistics plus any ;* Percentiles or Confidence Intervals. ;*----------------------------------------------------------------------;
proc univariate data=_anal11 noprint;
;
by _datasrt _blcksrt _trt;
var AGETR01;
output out=_msum11 CSS=CSS CV=CV KURTOSIS=KURTOSIS MAX=MAX MEAN=MEAN N=N
MIN=MIN MODE=MODE RANGE=RANGE NMISS=NMISS NOBS=NOBS STDMEAN=STDMEAN
SKEWNESS=SKEWNESS STD=STD USS=USS SUM=SUM VAR=VAR MEDIAN=MEDIAN P1=P1
P5=P5
P10=P10 P90=P90 P95=P95 P99=P99 Q1=Q1 Q3=Q3 QRANGE=QRANGE GINI=GINI MAD=MAD
QN=QN SN=SN STD_GINI=STD_GINI STD_MAD=STD_MAD STD_QN=STD_QN
STD_QRANGE=STD_QRANGE STD_SN=STD_SN NORMAL=NORMAL PROBN=PROBN
MSIGN=MSIGN
PROBM=PROBM SIGNRANK=SIGNRANK PROBS=PROBS T=T PROBT=PROBT;
run;*---------------------------------------------------------------------;
*Create Frame dataset when user requested Subgrouping as well as set;*sparsesgrpyn to Y to sparse subgrp categories of a format.;*-----------------------------------------------------------------------;
data _frame11;
set _bydat1(keep=);
_datasrt=1;
_blcksrt=9;
_catord=1;
_trt=1;
_cat=1;
output;
_trt=2;
_cat=1;
output;
_trt=3;
_cat=1;
FDA-CBER-2022-5812-0072686
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] output;
run;
proc sort data=_frame11;
by _datasrt _blcksrt _trt;
run;data _msum11;
merge _msum11 _frame11;
by _datasrt _blcksrt _trt;
run;*----------------------------------------------------------------------;
* Generate _result1 from OUT= dataset of PROC UNIVARIATE ;*----------------------------------------------------------------------;
data _result1_11;
if 0 then
set _basetemplate;
set _msum11 end=eof;
_rowsrt=0 + 1;
_rwlabel="Mean (SD) ";
_cvalue=' ';
_nvalue=.;
*----------------------------------------------------------------------;
* MEAN(STD) ;
*----------------------------------------------------------------------;
if mean ne . and std ne . then
do;
_cValue=strip(put(mean, 5.1) ) || ' (' || strip(put(std, 5.2) ) || ')';
end;
else if mean eq . then
_cValue="-" || ' (' || "-" || ')';
else if std eq . then
do;
_cValue=strip(put(mean, 5.1) ) || ' (' || "NE" || ')';
end;
output;
_rowsrt=0 + 2;
_rwlabel="Median ";
_cvalue=' ';
_nvalue=.;
_nvalue=MEDIAN;
if MEDIAN ne . then
_cValue=strip(put(MEDIAN, 5.1) );
else
_cValue="-";
output;
_rowsrt=0 + 3;
_rwlabel="Min, max ";
_cvalue=' ';
_nvalue=.;
FDA-CBER-2022-5812-0072687
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] *----------------------------------------------------------------------;
* MINMAX MINMAXC MEDIAN(MINMAX) MEDIAN(MINMAXC) ;
*----------------------------------------------------------------------;
_cValue=' ';
if min ^=. & max ^=. then
do;
_cValue=trim(_cvalue) || ' (' || strip(put(min, 5.0)
)|| ', ' || strip(put(max, 5.0) )||')';
end;
else if min=. & max=. then
do;
_cValue=trim(_cvalue) || ' (' || "-" || ', ' || "-" ||')';
end;
_cValue=compbl(_cValue);
output;
run;
*-------------------------------------------------------------------------;
* Generate _logresult1 from OUT= dataset of PROC UNIVARIATE for log stats;*-------------------------------------------------------------------------;
data _logresult1_11;
if 0 then
set _basetemplate;
stop;
run;*----------------------------------------------------------------------;
* Generate _result2 from confidence interval output dataset ;*----------------------------------------------------------------------;
data _result2_11;
if 0 then
set _basetemplate;
stop;
run;*----------------------------------------------------------------------------;
* Generate _logresult2 from confidence interval output dataset for log stats;*----------------------------------------------------------------------------;
data _logresult2_11;
if 0 then
set _basetemplate;
stop;
run;*----------------------------------------------------------------------;
* Combine to form one result dataset. Set variables that do not depend ;* on the statistic. Sort the result. ;*----------------------------------------------------------------------;
data _base11;
FDA-CBER-2022-5812-0072688
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] set _result1_11 _result2_11 _logresult1_11 _logresult2_11;
;
if _trt=4 then
_trt=9999;
_varname="AGETR01";
_vrlabel="Age at vaccination (years) ";
_datatyp='data';
_module='msumstat';
_indent=5;
_rowjump=1;
_dptindt=0;
run;
*----------------------------------------------------------------------;
* merge ISAM subgroup variables _SUBCAT _COLABEL ;*----------------------------------------------------------------------;
proc sort data=_base11;
by _datasrt _blcksrt _rowsrt;
run;********************************************************************************;
*SPECIFICATION 8 -2) AgeTR0x (Age at Each Dose) - descriptive statistics *;********************************************************************************;********************************************************************************;*SPECIFICATION 10 -1) titles and footnotes *;* 2) display *;********************************************************************************;
proc sql noprint;
select max(_trt) into :maxtrt from _base1;
quit;data _base1;
set _base1;
if (_module="mcatstat" and _trt=1 and _trt1=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=2 and _trt2=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=3 and _trt3=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
run;proc sql noprint;
select max(_trt) into :maxtrt from _base2;
quit;
FDA-CBER-2022-5812-0072689
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]data _base2;
set _base2;
if (_module="mcatstat" and _trt=1 and _trt1=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=2 and _trt2=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=3 and _trt3=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
run;
proc sql noprint;
select max(_trt) into :maxtrt from _base3;
quit;data _base3;
set _base3;
if (_module="mcatstat" and _trt=1 and _trt1=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=2 and _trt2=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=3 and _trt3=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
run;proc sql noprint;
select max(_trt) into :maxtrt from _base4;
quit;data _base4;
set _base4;
if (_module="mcatstat" and _trt=1 and _trt1=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=2 and _trt2=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=3 and _trt3=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
FDA-CBER-2022-5812-0072690
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]run;
proc sql noprint;
select max(_trt) into :maxtrt from _base5;
quit;
data _base5;
set _base5;
if (_module="mcatstat" and _trt=1 and _trt1=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=2 and _trt2=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=3 and _trt3=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
run;proc sql noprint;
select max(_trt) into :maxtrt from _base6;
quit;data _base6;
set _base6;
if (_module="mcatstat" and _trt=1 and _trt1=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=2 and _trt2=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=3 and _trt3=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
run;proc sql noprint;
select max(_trt) into :maxtrt from _base7;
quit;data _base7;
set _base7;
if (_module="mcatstat" and _trt=1 and _trt1=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=2 and _trt2=0) or (_module="msumstat" and
FDA-CBER-2022-5812-0072691
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=3 and _trt3=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
run;
proc sql noprint;
select max(_trt) into :maxtrt from _base8;
quit;data _base8;
set _base8;
if (_module="mcatstat" and _trt=1 and _trt1=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=2 and _trt2=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=3 and _trt3=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
run;proc sql noprint;
select max(_trt) into :maxtrt from _base9;
quit;data _base9;
set _base9;
if (_module="mcatstat" and _trt=1 and _trt1=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=2 and _trt2=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=3 and _trt3=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
run;proc sql noprint;
select max(_trt) into :maxtrt from _base10;
quit;data _base10;
set _base10;
FDA-CBER-2022-5812-0072692
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] if (_module="mcatstat" and _trt=1 and _trt1=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=2 and _trt2=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
if (_module="mcatstat" and _trt=3 and _trt3=0) or (_module="msumstat" and
sum=.) then
_cvalue="(*ESC*){nbspace 5}";
run;
data _final;
set _base1 _base2 _base3 _base4 _base5 _base6 _base7 _base8 _base9 _base10
_base11;
run;proc sort data=_final;
by _datasrt _blcksrt _rowsrt;
run;*----------------------------------------------------------------------;
* At least one of TRT and STAT is vertical;*----------------------------------------------------------------------;
data _final;
set _final;
drop __trt;
if _trt=9999 then
__trt=3 + 1;
else
__trt=_trt;
if __trt=. then
__trt=1;
_column=_trt;
if _column=9999 then
_column=3 + 1;
run;proc sort data=_final out=_final;
by _datasrt _blcksrt _rowsrt _column;
run;data _linecnt;
set _final end=eof;
by _datasrt _blcksrt _rowsrt _column;
retain _totline _maxval _maxrow _rwlbtag _vrlbtag 0 _maxline _linecnt;
keep _datasrt _blcksrt _totline _linecnt _maxrow;
FDA-CBER-2022-5812-0072693
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] if _rowjump=. then
_rowjump=1;
if first._blcksrt then
do;
*----------------------------------------------------------------------;
* Count words inside DATA step ;
*----------------------------------------------------------------------;
_token=repeat(' ', 99);
_count=1;
_token=scan(_vrlabel, _count, "|");
if _token=: '_' then
_tag=1;
else
_tag=0;
do while(_token ^=' ');
_count=_count + 1;
_token=scan(_vrlabel, _count, "|");
end;
_linecnt=_count - 1 + _tag;
;
_totline=_linecnt;
if _vrlabel ne ' ' and _vrlabel ne '^' & _datatyp='data' then
_vrlbtag=1;
end;
if first._rowsrt then
do;
*----------------------------------------------------------------------;
* Count words inside DATA step ;
*----------------------------------------------------------------------;
_token=repeat(' ', 99);
_count=1;
_token=scan(_rwlabel, _count, "|");
if _token=: '_' then
_tag=1;
else
_tag=0;
do while(_token ^=' ');
_maxrow=max(_maxrow, length(_token) + _indent);
_count=_count + 1;
_token=scan(_rwlabel, _count, "|");
end;
_maxline=_count - 1 + _tag;
if _rwlabel ne ' ' then
_rwlbtag=1;
_totline + _rowjump - 1;
end;
FDA-CBER-2022-5812-0072694
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] *----------------------------------------------------------------------;
* Count words inside DATA step ;
*----------------------------------------------------------------------;
_token=repeat(' ', 99);
_count=1;
_token=scan(_cvalue, _count, "|");
if _token=: '_' then
_tag=1;
else
_tag=0;
do while(_token ^=' ');
_maxval=max(_maxval, length(_token));
_count=_count + 1;
_token=scan(_cvalue, _count, "|");
end;
_ccnt=_count - 1 + _tag;
_maxline=max(_maxline, _ccnt);
if last._rowsrt then
_totline=_maxline + _totline;
if last._blcksrt then
do;
_totline=_totline - _rowjump + 1;
output;
end;
if eof then
do;
call symput('_valwid', compress(put(_maxval, 3.)));
call symput('_rwlbtag', put(_rwlbtag, 1.));
call symput('_vrlbtag', put(_vrlbtag, 1.));
end;
run;
data _final;
length _direct $20;
_direct=' ';
merge _final _linecnt;
by _datasrt _blcksrt;
run;proc sql noprint;
create table rspon as select distinct _trt, _column , _vrlabel as _rwlabel ,
_datasrt, _blcksrt, (min(_rowsrt)-0.5) as _rowsrt , _dptindt as _indent , 0
as _dptindt from _final(where=(_vrlabel^=' ')) group by _trt, _column ,
_datasrt, _blcksrt, _vrlabel;
quit;data ADSL_S005_ALL1_PED6_SAF;
length _rvalue $800;
set _final rspon end=eof;
FDA-CBER-2022-5812-0072695
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] _rwindt=sum(_indent, _dptindt);
if _rwindt <=0 then
_rvalue=_rwlabel;
/* else _rvalue=repeat(byte(160),_rwindt-1)||_rwlabel; */
else
_rvalue=repeat("~{nbspace 1}", _rwindt-1)||_rwlabel;
_dummy=1;
if _trt=. then
_trt=1;
run;
proc sort data=ADSL_S005_ALL1_PED6_SAF;
by _datasrt _trt _blcksrt _rowsrt;
run;data treat;
length FMTNAME $8 start 8 label $200;
fmtname='TREAT';
do start=1 to 3 + ("N"="Y");
label=symget('_TRTLB'|| compress(put(start, 4.)));
label=trim(label)
|| "| (N~{super a}=" || compress(symget("_TRT" || compress(put(start,
4.)))) || ")"
|| "|n~{super b} (%)";
output;
end;
run;proc format cntlin=treat;
run;
options orientation=LANDSCAPE papersize="LETTER";
ods escapechar="~";title1 "Demographic Characteristics (*ESC*){unicode 2013} Phase 2/3 Subjects 12 Through 15 Years of Age (*ESC*){unicode 2013} Safety Population ";footnote1
"Abbreviation: SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. ";
footnote2 "a.(*ESC*){nbspace 5}N = number of subjects in the specified group, or the total sample. This value is the denominator for the percentage calculations. ";footnote3 "b.(*ESC*){nbspace 5}n = Number of subjects with the specified characteristic. ";footnote4 "c.(*ESC*){nbspace 5}Positive N-binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID-19. ";footnote5 "d.(*ESC*){nbspace 5}Negative N-binding antibody result at Visit 1, negative NAAT result at Visit 1, and no medical history of COVID-19. ";footnote6 "e.(*ESC*){nbspace 5}Number of subjects who have 1 or more comorbidities that increase the risk of severe COVID-19 disease: defined as subjects who had at least one of the Charlson comorbidity index category or BMI (*ESC*){unicode 2265}95(*ESC*){super th} percentile. ~n f.(*ESC*){nbspace 5}Obese is defined as BMI (*ESC*){unicode 2265}95(*ESC*){super th} percentile from the growth chart. Refer to the CDC growth charts at https://www.cdc.gov/growthcharts/html_charts/bmiagerev.htm. ";
FDA-CBER-2022-5812-0072696
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]data outdata1;
set ADSL_S005_ALL1_PED6_SAF;
if upcase(_module)='MCATSTAT' then
_cvalue=transtrn(compress(_cvalue), '(', ' (');
_fixvar=1;
_fix2var=1;
run;
option nobyline;proc sort data=outdata1;
by _datasrt _trt _blcksrt _rowsrt;
run;proc sql noprint;
select distinct start, label into :start1, :_trlbl1 - :_trlbl99 from treat
order by start;
quit;proc sort data=outdata1 out=_pre_transposed;
by _fixvar _fix2var _datasrt _blcksrt _rowsrt _rvalue _trt;
run;data _pre_transposed;
set _pre_transposed;
if _trt=9999 then
_trt=3 +1;
run;proc transpose data=_pre_transposed out=_column_transposed (drop=_name_)
prefix=TRT;
by _fixvar _fix2var _datasrt _blcksrt _rowsrt _rvalue;
var _cvalue;
id _trt;
run;ods html file="&outtable.";data REPORT;
set _column_transposed;
_dummy=1;
run;proc sort data=report;
by _datasrt _blcksrt _rowsrt _dummy;
run;proc report data=report nowd list missing contents="" split="|" spanrows
style(report)={} style(header)={} style(column)={};
column _fixvar _fix2var _datasrt _blcksrt _rowsrt ("" _rvalue)
("Vaccine Group (as Administered)~{line}" ("" TRT1 TRT2) TRT3 _dummy);
define _fixvar / group noprint;
FDA-CBER-2022-5812-0072697
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM] define _fix2var / group noprint;
define _datasrt / group order=internal noprint;
define _blcksrt / group order=internal noprint;
define _rowsrt / group order=internal noprint;
define _rvalue / group id " " order=data style(column)={just=left width=60mm
rightmargin=18px} style(header)={just=left} left;
;
define _dummy / sum noprint;
define TRT1 / group nozero "&_trlbl1." spacing=2 style(column)={width=35mm
leftmargin=12px} style(header)={just=center} center;
define TRT2 / group nozero "&_trlbl2." spacing=2 style(column)={width=35mm
leftmargin=12px} style(header)={just=center} center;
define TRT3 / group nozero "&_trlbl3." spacing=2 style(column)={width=35mm
leftmargin=12px} style(header)={just=center} center;
break before _fixvar / contents="" page;
compute before _fix2var;
line @1 " ~n ";
endcomp;
compute after _blcksrt;
line " ~n ";
endcomp;
run;
ods HTML close;proc printto;
run;
FDA-CBER-2022-5812-0072698