Document text
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]***********************************************************************************************;
** Program Name : adsl-demo-7d-wwo-peds-eval-eff.sas **;** Date Created : 15Nov2021 **;** Programmer Name : **;
** Purpose : Create adsl-demo-7d-wwo-peds-eval-eff **;** Input data : adsl, adc19ef **;** Output file : adsl-demo-7d-wwo-peds-eval-eff.html **;***********************************************************************************************;options mprint mlogic symbolgen 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/analy
sis/eSUB;%let codename=adsl-demo-7d-wwo-peds-eval-eff;libname datvprot "&bprot.data_vai" access=readonly;%let outlog=&prot./logs/&codename..log;%let outtable=&prot./output/&codename..html;
proc printto log="&outlog." new;
run;
******************************************************************************************;
* Clean *;******************************************************************************************;
proc delete data=work._all_;
run;
proc format;
value sex 1='Male' 2='Female'; value ethnic 1='Hispanic/Latino' 2='Non-Hispanic/non-Latino' 3='Not reported' 4='Unknown'; value crace 1="White" 2="Black or African American" 2.5="All others" 3="(*ESC*){nbspace 5}American Indian or Alaska Native" 4="(*ESC*){nbspace 5}Asian" 5="(*ESC*){nbspace 5}Native Hawaiian or other Pacific Islander" 6="(*ESC*){nbspace 5}Multiracial" 7="(*ESC*){nbspace 5}Not reported" 8="(*ESC*){nbspace 5}Unknown";run;
proc sort data=datvprot.adsl out=adsl;
by usubjid;run;
proc sort data=datvprot.adc19ef out=adc19ef(keep=usubjid PDSDMFL VRBLNGFL
CRD1NGFL PDP17FL PDP27FL) nodupkey;
(b) (4), (b) (6)
FDA-CBER-2022-5812-0072511
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] by usubjid;
run;
data adsl;
merge adsl(in=a) adc19ef; by usubjid;
if a;
run;
data adsl;
set adsl(in=a); by usubjid;
if a;
length covblstx COMBODFLX OBSCATFL $50.;
if covblst="POS" then
do; covblstx="Positive(*ESC*){super e}"; covblstnx=1; end; else if covblst="NEG" then do; covblstx="Negative(*ESC*){super f}"; covblstnx=2; end; else if covblst not in ("POS" "NEG") then do; covblstx="Unknown"; covblstnx=3; end;
if COMBODFL='Y' or /*(bmicatn = 4 and age >=16) or*/
OBESEFL="Y" then do; COMBODFLNX=1; COMBODFLX="Yes"; end; else
/* if COMBODFL='N' then */
do; COMBODFLNX=2; COMBODFLX="No"; end;
if /*(bmicatn = 4 and AGETR01 >=16) or*/
OBESEFL="Y" then do; OBSCATFN=1; OBSCATFL="Yes"; end;
else
FDA-CBER-2022-5812-0072512
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] do;
OBSCATFN=2;
OBSCATFL="No"; end;
if racialdn=999 then
racialdn=.;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 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 race_ao;
set adsl;
if aracen not in (1, 2);
aracen=2.5; arace="ALL OTHERS"; AGETR01=.;run;
data adsl;
set adsl race_ao;run;
data adsl;
set adsl; length agegr1x $50.;
if 12<=age<=15 then
do; agegr1nx=1; agegr1x="12 to 15 "; end;
if 16<=age<=55 then
do;
FDA-CBER-2022-5812-0072513
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] agegr1nx=2;
agegr1x="16 to 55 ";
end;
if age>55 then
do; agegr1nx=3; agegr1x="(*ESC*){Unicode 003E}55 "; end;run;
data agp1;
set adsl;
if 16<=age<=17;
agegr1nx=5; agegr1x="16 to 17 "; AGETR01=.;run;
data agp2;
set adsl;
if 16<=age<=25;
agegr1nx=6; agegr1x="16 to 25 "; AGETR01=.;run;
data agp3;
set adsl;
if 16<=age<=64;
agegr1nx=7; agegr1x="16 to 64 "; AGETR01=.;run;
data agp4;
set adsl;
if 18<=age<=64;
agegr1nx=8; agegr1x="18 to 64 "; AGETR01=.;run;
data agp5;
set adsl;
if 55<=age<=64;
agegr1nx=9; agegr1x="55 to 64 ";
AGETR01=.;
FDA-CBER-2022-5812-0072514
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]run;
data agp7;
set adsl;
if age>=65;
agegr1nx=4; agegr1x="(*ESC*){unicode 2265}65 "; AGETR01=.;run;
data agp8;
set adsl;
if 65<=age<=74;
agegr1nx=10; agegr1x="65 to 74 "; AGETR01=.;run;
data agp9;
set adsl;
if age>=75;
agegr1nx=11; agegr1x="(*ESC*){unicode 2265}75 "; AGETR01=.;run;
data agp10;
set adsl;
if 75<=age<=85;
agegr1nx=12; agegr1x="75 to 85 "; AGETR01=.;run;
data agp11;
set adsl;
if age>85;
agegr1nx=13; agegr1x="(*ESC*){Unicode 003E}85 "; AGETR01=.;run;
data adsl;
set adsl agp1 agp2 agp3 agp4 agp5 agp7 agp8 agp9 agp10 agp11;run;
data g_adsl_dsin;
set adsl;
where EVALEFFL="Y" and PDP27FL in ('Y' 'N') and agegr1n=1 and phasen ne 1;
FDA-CBER-2022-5812-0072515
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]run;
data __trtmap;
length trtcode trtdecd $100;
if 0 then
set g_adsl_dsin(keep=TRT01PN); trtval=1;
if vtype(TRT01PN)='C' then
trtcode=tranwrd(compbl(quote("8")), ' ', '" "'); else trtcode="8"; trtdecd="BNT162b2 (30 (*ESC*){unicode 03BC}g)"; trtvar="TRT01PN"; trtlbl="TRT01P"; output; trtval=2;
if vtype(TRT01PN)='C' then
trtcode=tranwrd(compbl(quote("9")), ' ', '" "'); else trtcode="9"; trtdecd="Placebo"; trtvar="TRT01PN"; trtlbl="TRT01P"; output; trtval=3;
if vtype(TRT01PN)='C' then
trtcode=tranwrd(compbl(quote("8 9")), ' ', '" "'); else trtcode="8 9"; trtdecd="Total"; trtvar="TRT01PN"; trtlbl="TRT01P"; output; stop;run;
data g_adsl_dsin;
set g_adsl_dsin;
if TRT01PN in (8) then
do; newtrtn=1; newtrt=coalescec("BNT162b2 (30 (*ESC*){unicode 03BC}g)", TRT01P); output; end;
if TRT01PN in (9) then
do; newtrtn=2;
newtrt=coalescec("Placebo", TRT01P);
FDA-CBER-2022-5812-0072516
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] output;
end;
if TRT01PN in (8 9) then
do; newtrtn=3; newtrt=coalescec("Total", TRT01P); 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;
proc sql noprint;
FDA-CBER-2022-5812-0072517
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] select put(nobs - delobs, 12.) into :_nobs from dictionary.tables
where (libname="WORK" and memname="_DATA1");
select setting into :miss from dictionary.options where upcase(optname)="MISSING";quit;
*----------------------------------------------------------------------;
* Count number of treatment groups ;*----------------------------------------------------------------------;
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;
FDA-CBER-2022-5812-0072518
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]*----------------------------------------------------------------------;
* 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 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 _null_;
set _data1 end=eof;
FDA-CBER-2022-5812-0072519
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] if eof then
call symput('dptlab', vlabel(SEXN));run;
data _anal1;
length SEXN 8; set _data1;
if SEXN=. then
SEXN=9998; _blcksrt=1; _cnt=1; _cat=1;
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;
FDA-CBER-2022-5812-0072520
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] 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; _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;
FDA-CBER-2022-5812-0072521
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] 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; 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;
FDA-CBER-2022-5812-0072522
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] 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);
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;
FDA-CBER-2022-5812-0072523
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] 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. ;* 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;
FDA-CBER-2022-5812-0072524
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] 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.); *----------------------------------------------------------------------; * 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;
FDA-CBER-2022-5812-0072525
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] _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 _null_;
set _data1 end=eof;
if eof then
call symput('dptlab', vlabel(ARACEN));
run;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
FDA-CBER-2022-5812-0072526
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] 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;*----------------------------------------------------------------------;
* 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;
FDA-CBER-2022-5812-0072527
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]*----------------------------------------------------------------------;
* 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;
_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;
_catLabl=" ";
_trt=1;
ARACEN=2.5;
_catord=3;
_cat=1;
output;
_trt=2;
ARACEN=2.5;
_catord=3;
_cat=1;
output;
_trt=3;
FDA-CBER-2022-5812-0072528
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] ARACEN=2.5;
_catord=3;
_cat=1;
output;
_catLabl=" ";
_trt=1;
ARACEN=3;
_catord=4;
_cat=1;
output;
_trt=2;
ARACEN=3;
_catord=4;
_cat=1;
output;
_trt=3;
ARACEN=3;
_catord=4;
_cat=1;
output;
_catLabl=" ";
_trt=1;
ARACEN=4;
_catord=5;
_cat=1;
output;
_trt=2;
ARACEN=4;
_catord=5;
_cat=1;
output;
_trt=3;
ARACEN=4;
_catord=5;
_cat=1;
output;
_catLabl=" ";
_trt=1;
ARACEN=5;
_catord=6;
_cat=1;
output;
_trt=2;
ARACEN=5;
_catord=6;
_cat=1;
output;
_trt=3;
ARACEN=5;
_catord=6;
_cat=1;
output;
_catLabl=" ";
_trt=1;
FDA-CBER-2022-5812-0072529
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] ARACEN=6;
_catord=7;
_cat=1;
output;
_trt=2;
ARACEN=6;
_catord=7;
_cat=1;
output;
_trt=3;
ARACEN=6;
_catord=7;
_cat=1;
output;
_catLabl=" ";
_trt=1;
ARACEN=7;
_catord=8;
_cat=1;
output;
_trt=2;
ARACEN=7;
_catord=8;
_cat=1;
output;
_trt=3;
ARACEN=7;
_catord=8;
_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;
FDA-CBER-2022-5812-0072530
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]*----------------------------------------------------------------------;
* Delete Zero filled MISSING category rows for each combination of;
* _datasrt &_byvar _blcksrt;*----------------------------------------------------------------------;
proc sort data=_pct2;
by _datasrt _blcksrt ARACEN;
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;
FDA-CBER-2022-5812-0072531
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]data _pct2;
if 0 then
set _basetemplate;
merge _denomin2(in=_a) _pct2;
by _datasrt _cat;
if _a;
_varname="ARACEN ";
_vrlabel="Race ";
_rwlabel=put(ARACEN, crace.);
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 ;
*----------------------------------------------------------------------;
FDA-CBER-2022-5812-0072532
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] 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=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;
********************************************************************************;
*SPECIFICATION 5 -1) Ethnicity - n and percent *;
FDA-CBER-2022-5812-0072533
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]********************************************************************************;
data _anal3;
length ETHNICN 8;
set _data1;
where same and ETHNICN is not missing;
_blcksrt=3;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal3;
by _datasrt _blcksrt ETHNICN _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 ETHNICN _trt USUBJID;
run;proc freq data=_temp93;
format ETHNICN;
tables _datasrt*_blcksrt*_cat * ETHNICN * _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;
FDA-CBER-2022-5812-0072534
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]run;
*----------------------------------------------------------------------;
* Create _DENOMF a frame dataset for the denominators ;*----------------------------------------------------------------------;
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 transpose data=_denom3 out=_denomin3(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 _anal3;
select distinct ETHNICN into :expv1 - :expv3 from _anal3 order by ETHNICN;
quit;*----------------------------------------------------------------------;
* Create _FRAME dataset using all combinations of category variable ;*----------------------------------------------------------------------;
data _frame3;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=3;
length ETHNICN 8;
_catLabl=" ";
_trt=1;
ETHNICN=1;
_catord=1;
_cat=1;
output;
_trt=2;
ETHNICN=1;
FDA-CBER-2022-5812-0072535
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] _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=_frame3;
by _datasrt _blcksrt _cat ETHNICN _trt;
run;proc sort data=_pct3;
by _datasrt _blcksrt _cat ETHNICN _trt;
run;
FDA-CBER-2022-5812-0072536
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]data _pct3;
merge _frame3(in=_inframe) _pct3;
by _datasrt _blcksrt _cat ETHNICN _trt;
if _inframe;
if count=. then
count=0;
run;
proc sort data=_pct3;
by _datasrt _blcksrt ETHNICN;
run;data _miss3(keep=_datasrt _blcksrt ETHNICN totcount);
set _pct3;
where ETHNICN=9998;
retain totcount;
by _datasrt _blcksrt ETHNICN;
if first.ETHNICN then
totcount=0;
totcount=totcount+count;
if last.ETHNICN;
run;data _pct3(drop=totcount);
merge _pct3 _miss3;
by _datasrt _blcksrt ETHNICN;
if totcount=0 then
delete;
run;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=3;
run;proc sort data=_pct3;
by _datasrt _cat;
run;
FDA-CBER-2022-5812-0072537
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]data _pct3;
if 0 then
set _basetemplate;
merge _denomin3(in=_a) _pct3;
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=_pct3;
by _datasrt _blcksrt _catord ETHNICN _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 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
_cvalue=put(0, 5.);
*----------------------------------------------------------------------;
* Format percent to append to display value in _CVALUE ;
*----------------------------------------------------------------------;
FDA-CBER-2022-5812-0072538
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] 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;
data _anal4;
length COUNTRYX $50;
set _data1;
FDA-CBER-2022-5812-0072539
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] where same and COUNTRYX is not missing;
_blcksrt=4;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal4;
by _datasrt _blcksrt COUNTRYX _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 COUNTRYX _trt USUBJID;
run;proc freq data=_temp94;
format COUNTRYX;
tables _datasrt*_blcksrt*_cat * COUNTRYX * _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 ;*----------------------------------------------------------------------;
FDA-CBER-2022-5812-0072540
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]data _denomf4;
_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 transpose data=_denom4 out=_denomin4(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;proc sort data=_pct4 out=_expv4 (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="_PCT4");
select setting into :miss from dictionary.options where
upcase(optname)="MISSING";
quit;proc sort data=_expv4;
by _datasrt _blcksrt COUNTRYX;
run;data _frame4;
set _expv4;
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;
FDA-CBER-2022-5812-0072541
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]*----------------------------------------------------------------------;
* Merge the _PCT dataset with its frameup dataset(_FRAME) ;*----------------------------------------------------------------------;
proc sort data=_frame4;
by _datasrt _blcksrt _cat COUNTRYX _trt;
run;proc sort data=_pct4;
by _datasrt _blcksrt _cat COUNTRYX _trt;
run;data _pct4;
merge _frame4(in=_inframe) _pct4;
by _datasrt _blcksrt _cat COUNTRYX _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct4;
by _datasrt _blcksrt COUNTRYX;
run;data _miss4(keep=_datasrt _blcksrt COUNTRYX totcount);
set _pct4;
where COUNTRYX='ZZZY';
retain totcount;
by _datasrt _blcksrt COUNTRYX;
if first.COUNTRYX then
totcount=0;
totcount=totcount+count;
if last.COUNTRYX;
run;data _pct4(drop=totcount);
merge _pct4 _miss4;
by _datasrt _blcksrt COUNTRYX;
if totcount=0 then
delete;
run;proc sort data=_denomf4;
by _datasrt _cat;
run;proc sort data=_denomin4;
by _datasrt _cat;
FDA-CBER-2022-5812-0072542
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]run;
data _denomin4;
merge _denomf4(in=_inframe) _denomin4;
by _datasrt _cat;
if _inframe;
_blcksrt=4;
run;
proc sort data=_pct4;
by _datasrt _cat;
run;data _pct4;
if 0 then
set _basetemplate;
merge _denomin4(in=_a) _pct4;
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;
if _catord=. then
_catord=9997;
run;proc sort data=_pct4;
by _datasrt _blcksrt _catord COUNTRYX _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 COUNTRYX _trt _cat;
retain _rowsrt 0 _rowmax 0;
FDA-CBER-2022-5812-0072543
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 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.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=' ';
FDA-CBER-2022-5812-0072544
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 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 _anal5;
length COMBODFLNX 8;
set _data1;
where same and COMBODFLNX is not missing;
_blcksrt=5;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;proc sort data=_anal5;
by _datasrt _blcksrt COMBODFLNX _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 COMBODFLNX _trt USUBJID;
run;proc freq data=_temp95;
format COMBODFLNX;
tables _datasrt*_blcksrt*_cat * COMBODFLNX * _trt / sparse norow nocol
nopercent out=_pct5(drop=percent);
run;proc sort data=_anal5 out=_denom5(keep=_datasrt _cat) nodupkey;
by _datasrt _cat;
run;data _denom5;
set _denom5;
by _datasrt _cat;
label count='count';
FDA-CBER-2022-5812-0072545
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] _trt=1;
count=&_trt1;
output;
_trt=2;
count=&_trt2;
output;
_trt=3;
count=&_trt3;
output;
run;
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 transpose data=_denom5 out=_denomin5(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;proc sql noprint;
select count(distinct COMBODFLNX) into : totexpv from _anal5;
select distinct COMBODFLNX , COMBODFLX into :expv1 - :expv2 ,
:catlab1 - :catlab2 from _anal5 order by COMBODFLNX;
quit;data _frame5;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=5;
length COMBODFLNX 8;
length _catLabl $50;
_catLabl=' ';
_catLabl="Yes ";
_trt=1;
COMBODFLNX=1;
_catord=1;
_cat=1;
output;
_trt=2;
COMBODFLNX=1;
_catord=1;
_cat=1;
output;
_trt=3;
FDA-CBER-2022-5812-0072546
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] 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;
proc sort data=_frame5;
by _datasrt _blcksrt _cat COMBODFLNX _trt;
run;proc sort data=_pct5;
by _datasrt _blcksrt _cat COMBODFLNX _trt;
run;data _pct5;
merge _frame5(in=_inframe) _pct5;
by _datasrt _blcksrt _cat COMBODFLNX _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct5;
by _datasrt _blcksrt COMBODFLNX;
run;data _miss5(keep=_datasrt _blcksrt COMBODFLNX totcount);
set _pct5;
where COMBODFLNX=9998;
retain totcount;
by _datasrt _blcksrt COMBODFLNX;
if first.COMBODFLNX then
totcount=0;
totcount=totcount+count;
FDA-CBER-2022-5812-0072547
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] if last.COMBODFLNX;
run;
data _pct5(drop=totcount);
merge _pct5 _miss5;
by _datasrt _blcksrt COMBODFLNX;
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=5;
run;proc sort data=_pct5;
by _datasrt _cat;
run;data _pct5;
if 0 then
set _basetemplate;
merge _denomin5(in=_a) _pct5;
by _datasrt _cat;
if _a;
_varname="COMBODFLNX ";
_vrlabel="Comorbidities(*ESC*){super c} ";
_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
FDA-CBER-2022-5812-0072548
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] _catord=9997;
run;
proc sort data=_pct5;
by _datasrt _blcksrt _catord COMBODFLNX _trt _cat;
run;data _base5;
length _catlabl $200;
set _pct5 end=eof;
by _datasrt _blcksrt _catord COMBODFLNX _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.);
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);
FDA-CBER-2022-5812-0072549
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] 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 OBSCATFN 8;
set _data1;
where same and OBSCATFN is not missing;
_blcksrt=6;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;proc sort data=_anal6;
by _datasrt _blcksrt OBSCATFN _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 OBSCATFN _trt USUBJID;
run;proc freq data=_temp96;
format OBSCATFN;
tables _datasrt*_blcksrt*_cat * OBSCATFN * _trt / sparse norow nocol nopercent
out=_pct6(drop=percent);
run;
FDA-CBER-2022-5812-0072550
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]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;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;proc transpose data=_denom6 out=_denomin6(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;proc sql noprint;
select count(distinct OBSCATFN) into : totexpv from _anal6;
select distinct OBSCATFN , OBSCATFL into :expv1 - :expv2 , :catlab1 - :catlab2
from _anal6 order by OBSCATFN;
quit;data _frame6;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=6;
length OBSCATFN 8;
length _catLabl $50;
_catLabl=' ';
_catLabl="Yes ";
_trt=1;
OBSCATFN=1;
FDA-CBER-2022-5812-0072551
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] _catord=1;
_cat=1;
output;
_trt=2;
OBSCATFN=1;
_catord=1;
_cat=1;
output;
_trt=3;
OBSCATFN=1;
_catord=1;
_cat=1;
output;
_catLabl="No ";
_trt=1;
OBSCATFN=2;
_catord=2;
_cat=1;
output;
_trt=2;
OBSCATFN=2;
_catord=2;
_cat=1;
output;
_trt=3;
OBSCATFN=2;
_catord=2;
_cat=1;
output;
run;
proc sort data=_frame6;
by _datasrt _blcksrt _cat OBSCATFN _trt;
run;proc sort data=_pct6;
by _datasrt _blcksrt _cat OBSCATFN _trt;
run;data _pct6;
merge _frame6(in=_inframe) _pct6;
by _datasrt _blcksrt _cat OBSCATFN _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct6;
by _datasrt _blcksrt OBSCATFN;
run;
data _miss6(keep=_datasrt _blcksrt OBSCATFN totcount);
FDA-CBER-2022-5812-0072552
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] set _pct6;
where OBSCATFN=9998;
retain totcount;
by _datasrt _blcksrt OBSCATFN;
if first.OBSCATFN then
totcount=0;
totcount=totcount+count;
if last.OBSCATFN;
run;
data _pct6(drop=totcount);
merge _pct6 _miss6;
by _datasrt _blcksrt OBSCATFN;
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=6;
run;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="OBSCATFN ";
_vrlabel="Obese(*ESC*){super d} ";
_rwlabel=_catLabl;
if OBSCATFN=9998 then
do;
_rwlabel="Missing ";
FDA-CBER-2022-5812-0072553
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] _catord=9998;
end;
else if OBSCATFN=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct6;
by _datasrt _blcksrt _catord OBSCATFN _trt _cat;
run;data _base6;
length _catlabl $200;
set _pct6 end=eof;
by _datasrt _blcksrt _catord OBSCATFN _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.);
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-2022-5812-0072554
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] * Put character A0x at right most character to pad text;
*----------------------------------------------------------------------;
substr(_cvalue, 13, 1)='A0'x;
end;
if first.OBSCATFN 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 _anal7;
length COVBLSTNX 8;
set _data1;
where same and COVBLSTNX is not missing;
_blcksrt=7;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;proc sort data=_anal7;
by _datasrt _blcksrt COVBLSTNX _trt _cat;
run;*--- Counts for each by-sequence, dependant var, and treatment combination ---*;data _temp7;
set _anal7;
output;
run;
FDA-CBER-2022-5812-0072555
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]proc sort data=_temp7 out=_temp97 nodupkey;
by _datasrt _blcksrt _cat COVBLSTNX _trt USUBJID;
run;
proc freq data=_temp97;
format COVBLSTNX;
tables _datasrt*_blcksrt*_cat * COVBLSTNX * _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;*----------------------------------------------------------------------;
* 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";
FDA-CBER-2022-5812-0072556
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]quit;
proc transpose data=_denom7 out=_denomin7(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 COVBLSTNX) into : totexpv from _anal7;
select distinct COVBLSTNX , covblstx into :expv1 - :expv3 ,
:catlab1 - :catlab3 from _anal7 order by COVBLSTNX;
quit;*----------------------------------------------------------------------;
* Create _FRAME dataset using all combinations of category variable ;*----------------------------------------------------------------------;
data _frame7;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=7;
length COVBLSTNX 8;
length _catLabl $50;
_catLabl=' ';
_catLabl="Positive(*ESC*){super e} ";
_trt=1;
COVBLSTNX=1;
_catord=1;
_cat=1;
output;
_trt=2;
COVBLSTNX=1;
_catord=1;
_cat=1;
output;
_trt=3;
COVBLSTNX=1;
_catord=1;
_cat=1;
output;
_catLabl="Negative(*ESC*){super f} ";
_trt=1;
COVBLSTNX=2;
_catord=2;
_cat=1;
output;
_trt=2;
COVBLSTNX=2;
_catord=2;
FDA-CBER-2022-5812-0072557
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] _cat=1;
output;
_trt=3;
COVBLSTNX=2;
_catord=2;
_cat=1;
output;
_catLabl="Unknown ";
_trt=1;
COVBLSTNX=3;
_catord=3;
_cat=1;
output;
_trt=2;
COVBLSTNX=3;
_catord=3;
_cat=1;
output;
_trt=3;
COVBLSTNX=3;
_catord=3;
_cat=1;
output;
run;
*----------------------------------------------------------------------;
* Merge the _PCT dataset with its frameup dataset(_FRAME) ;*----------------------------------------------------------------------;
proc sort data=_frame7;
by _datasrt _blcksrt _cat COVBLSTNX _trt;
run;proc sort data=_pct7;
by _datasrt _blcksrt _cat COVBLSTNX _trt;
run;data _pct7;
merge _frame7(in=_inframe) _pct7;
by _datasrt _blcksrt _cat COVBLSTNX _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=_pct7;
by _datasrt _blcksrt COVBLSTNX;
FDA-CBER-2022-5812-0072558
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]run;
data _miss7(keep=_datasrt _blcksrt COVBLSTNX totcount);
set _pct7;
where COVBLSTNX=9998;
retain totcount;
by _datasrt _blcksrt COVBLSTNX;
if first.COVBLSTNX then
totcount=0;
totcount=totcount+count;
if last.COVBLSTNX;
run;
data _pct7(drop=totcount);
merge _pct7 _miss7;
by _datasrt _blcksrt COVBLSTNX;
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=_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=7;
run;*----------------------------------------------------------------------;
* Merge in _PCT(counts) with the _DENOMIN(denominator for percents) ;*----------------------------------------------------------------------;
proc sort data=_pct7;
by _datasrt _cat;
run;
FDA-CBER-2022-5812-0072559
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]*----------------------------------------------------------------------;
* Create _VARNAME variable to hold depend variable name. ;
* Create _VRLABEL variable to display Group label. ;* Create _RWLABEL variable to display &dptvar categories. ;*----------------------------------------------------------------------;
data _pct7;
if 0 then
set _basetemplate;
merge _denomin7(in=_a) _pct7;
by _datasrt _cat;
if _a;
_varname="COVBLSTNX ";
_vrlabel="Baseline SARS-CoV-2 status ";
_rwlabel=_catLabl;
if COVBLSTNX=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if COVBLSTNX=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct7;
by _datasrt _blcksrt _catord COVBLSTNX _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 COVBLSTNX _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.);
FDA-CBER-2022-5812-0072560
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] 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.COVBLSTNX 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.)));
FDA-CBER-2022-5812-0072561
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] _direct="TOP ";
_p=2;
run;
********************************************************************************;
*SPECIFICATION 7 -1) Age - descriptive statistics *;********************************************************************************;
data _anal8;
set _data1;
where _trt > 0;
_blcksrt=8;
output;
run;*----------------------------------------------------------------------;
* Make sure data is sorted by groups ;*----------------------------------------------------------------------;
proc sort data=_anal8;
by _datasrt _blcksrt _trt;
run;*----------------------------------------------------------------------;
* Call PROC UNIVARIATE to generate all possible statistics plus any ;* Percentiles or Confidence Intervals. ;*----------------------------------------------------------------------;
proc univariate data=_anal8 noprint;
by _datasrt _blcksrt _trt;
var AGETR01;
output out=_msum8 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 _frame8;
set _bydat1(keep=);
_datasrt=1;
_blcksrt=8;
_catord=1;
_trt=1;
_cat=1;
FDA-CBER-2022-5812-0072562
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] output;
_trt=2;
_cat=1;
output;
_trt=3;
_cat=1;
output;
run;
proc sort data=_frame8;
by _datasrt _blcksrt _trt;
run;data _msum8;
merge _msum8 _frame8;
by _datasrt _blcksrt _trt;
run;*----------------------------------------------------------------------;
* Generate _result1 from OUT= dataset of PROC UNIVARIATE ;*----------------------------------------------------------------------;
data _result1_8;
if 0 then
set _basetemplate;
set _msum8 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
FDA-CBER-2022-5812-0072563
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] _cValue="-";
output;
_rowsrt=0 + 3;
_rwlabel="Min, max ";
_cvalue=' ';
_nvalue=.;
*----------------------------------------------------------------------;
* 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_8;
if 0 then
set _basetemplate;
stop;
run;*----------------------------------------------------------------------;
* Generate _result2 from confidence interval output dataset ;*----------------------------------------------------------------------;
data _result2_8;
if 0 then
set _basetemplate;
stop;
run;*----------------------------------------------------------------------------;
* Generate _logresult2 from confidence interval output dataset for log stats;*----------------------------------------------------------------------------;
data _logresult2_8;
if 0 then
set _basetemplate;
stop;
run;
FDA-CBER-2022-5812-0072564
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]*----------------------------------------------------------------------;
* Combine to form one result dataset. Set variables that do not depend ;
* on the statistic. Sort the result. ;*----------------------------------------------------------------------;
data _base8;
set _result1_8 _result2_8 _logresult1_8 _logresult2_8;
if _trt=4 then
_trt=9999;
_varname="AGETR01";
_vrlabel="Age at vaccination (years) ";
_datatyp='data';
_module='msumstat';
_indent=3;
_rowjump=1;
_dptindt=0;
run;*----------------------------------------------------------------------;
* merge ISAM subgroup variables _SUBCAT _COLABEL ;*----------------------------------------------------------------------;
proc sort data=_base8;
by _datasrt _blcksrt _rowsrt;
run;data _final;
set _base1 _base2 _base3 _base4 _base5 _base6 _base7 _base8;
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;
FDA-CBER-2022-5812-0072565
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]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;
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;
FDA-CBER-2022-5812-0072566
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] 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;
*----------------------------------------------------------------------;
* 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;
FDA-CBER-2022-5812-0072567
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]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_DEMO_7D_WWO_PEDS_EVAL_EFF;
length _rvalue $800; set _final rspon end=eof; _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_DEMO_7D_WWO_PEDS_EVAL_EFF;
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} Blinded Placebo-Controlled Follow-up Period (*ESC*){unicode 2013} ";title2 "Subjects 12 Through 15 Years of Age and With or Without Evidence of Infection Prior to 7 Days After Dose 2 (*ESC*){unicode 2013} ";title3 "Evaluable Efficacy (7 Days) Population ";footnote1 "a.(*ESC*){nbspace 5}N = number of subjects in the specified group, or the total sample. This value is the
FDA-CBER-2022-5812-0072568
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]denominator for the percentage calculations. ";
footnote2 "b.(*ESC*){nbspace 5}n = Number of subjects with the specified characteristic. ";
footnote3 "c.(*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. ";footnote4 "d.(*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. ";footnote5 "e.(*ESC*){nbspace 5}Positive N-binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID-19. ";footnote6 "f.(*ESC*){nbspace 5}Negative N-binding antibody result at Visit 1, negative NAAT result at Visit 1, and no medical history of COVID-19. ";
data outdata1;
set ADSL_DEMO_7D_WWO_PEDS_EVAL_EFF;
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;
FDA-CBER-2022-5812-0072569
file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM] 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 Randomized)~{line}" TRT1 TRT2) TRT3 _dummy);
define _fixvar / group noprint;
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-2022-5812-0072570