Document text
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]***********************************************************************************************;
** Program Name : adds-s002-all1-ped6.sas **;** Date Created : 15Nov2021 **;** Programmer Name : **;
** Purpose : Create adds-s002-all1-ped6 **;** Input data : adsl adds **;** Output data : adds-s002-all1-ped6.html **;***********************************************************************************************;options mprint mlogic symbolgen mprint symbolgen mlogic nocenter missing=" ";title;footnote;
**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=adds-s002-all1-ped6;
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;
proc datasets library=WORK kill nolist nodetails;
quit;
/* Format */
proc format; value dsdecod 1="Adverse event" 3="Death" 5="Lost to follow-up" 7="Other" 8="Physician decision" 9="Pregnancy" 11="Protocol deviation" 13="Screen Failure" 14="Study terminated by sponsor" 16="Withdrawal by subject" 17="Medication error without associated adverse event" 18="No longer meets eligibility criteria" 25="Refused further study procedures" 26="Withdrawal by parent/guardian";run;
/* Readin ADSL */
data g_a_dsin; set datvprot.ADDS; analysis_subset='Y';run;
data g_adsl_dsin;
set datvprot.adsl; where RANDFL eq 'Y' and AGEGR4N=1;run;
proc sql noprint;
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0072117
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] create table a_dsin as select * from g_a_dsin where usubjid in (select
distinct usubjid from g_adsl_dsin);
quit;
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;
FDA-CBER-2022-5812-0072118
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] newtrtn=2;
newtrt=coalescec("Placebo", TRT01P);
output; end;
if TRT01PN in (8 9) then
do; newtrtn=3; newtrt=coalescec("Total", TRT01P); output; end;run;
data g_a_dsin;
set g_a_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); output; end;
if TRT01PN in (8 9) then
do; newtrtn=3; newtrt=coalescec("Total", TRT01P); output; end;run;
proc sort data=g_adsl_dsin out=_ds1;
by usubjid newtrtn;run;
proc sort data=g_a_dsin out=_ds2;
by usubjid newtrtn;run;
data final;
merge _ds1(in=d1) _ds2(in=d2); by usubjid newtrtn;
if d1;
run;
data _basetemplate(compress=no);
FDA-CBER-2022-5812-0072119
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] length _varname $8 _cvalue $35 _direct $20 _vrlabel $200 _rwlabel
_colabel $800 _datatyp $5 _module $8 _pr_lbl $ 200;
array _c _character_; delete;run;
data _data1;
set final; where (NEWTRTN is not missing);run;
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; _str=NEWTRT;
if _trt > 0 then
call symput('_trtlb'||compress(put(_trt, 4.)), trim(left(_str))); end;run;
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;
proc sort data=_data1 out=_bydat1(keep=_datasrt _dummyby) nodupkey;
by _datasrt;run;
data _bydat1;
set _bydat1 end=eof;
by _datasrt;
FDA-CBER-2022-5812-0072120
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] 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;
/* Create criteria flags */
data _data1; set _data1; _event1=ifN(RANDFL in ('Y'), 1, 0); _event2=ifN(RANDFL eq 'Y' and (VAX101DT eq . and VAX102DT eq . and VAX10UDT=. and VAX201DT eq . and VAX202DT eq .), 1, 0); _event3=ifN(RANDFL eq 'Y' and (VAX101DT ne . or VAX102DT ne .), 1, 0); _event4=ifN(RANDFL eq 'Y' and VAX101DT ne . , 1, 0); _event5=ifN(RANDFL eq 'Y' and VAX102DT ne . and (VAX102DT<UNBLNDDT or UNBLNDDT=.), 1, 0); _event6=ifN(RANDFL eq 'Y' and DSPHASEN=26 and EOTDCDT ne . and dsdecodn not in (. 2) and (VAX101DT ne . or VAX102DT ne .) and (unblnddt=. or eotdcdt<unblnddt), 1, 0); _event8=ifN(RANDFL eq 'Y' and UNBLNDDT ne . and (UNBLNDDT<=M1PD2DT or M1PD2DT=.), 1, 0); _event9=ifN(RANDFL eq 'Y' and ((DSPHASEN=26 and dsdecodn=2) ) and (unblnddt=. or astdt<unblnddt), 1, 0); _event10=ifN(RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2) and (VAX101DT ne . or VAX102DT ne .) and (unblnddt=. or eosdcdt<unblnddt) and EOSDCDT ne EOTXDCDT, 1, 0); _event11=ifN(RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2) and vax101dt ne . and ((vax101dt<=astdt and vax102dt eq .) or vax101dt<=astdt < vax102dt) and (unblnddt=. or eosdcdt<unblnddt) and EOSDCDT
ne EOTXDCDT, 1, 0);
FDA-CBER-2022-5812-0072121
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _event12=ifN(RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not
in (. 2) and vax101dt ne . and vax102dt ne . and (vax102dt <=astdt
and (M1PD2DT eq . or astdt<M1PD2DT)) and (unblnddt=. or eosdcdt<unblnddt) and EOSDCDT ne EOTXDCDT, 1, 0); _event13=ifN(RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2) and vax101dt ne . and vax102dt ne . and M1PD2DT ne . and M1PD2DT le astdt and (unblnddt=. or eosdcdt<unblnddt) and EOSDCDT ne EOTXDCDT, 1, 0); _event15=ifN(RANDFL eq 'Y' and (UNBLNDDT ne . or vax201dt ne .) and index(arm, 'BNT'), 1, 0); _event16=ifN(RANDFL eq 'Y' and ((VAX102DT>=UNBLNDDT) or (index(VAX10u, 'BNT') and VAX10UDT>=UNBLNDDT)) and UNBLNDDT ne . and index(arm, 'BNT'), 1, 0); _event17=ifN(RANDFL eq 'Y' and ((DSPHASEN=26 and dsdecodn=2)) and (unblnddt ne . and astdt>=unblnddt) and index(arm, 'BNT'), 1, 0); _event18=ifN(RANDFL eq 'Y' and vax101dt ne . and vax102dt ne . and M6PD2DT ne . and (UNBLNDDT ne . or vax201dt ne .) and index(arm, 'BNT'), 1, 0); _event19=ifN(RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2) and (VAX101DT ne . or VAX102DT ne .) and (unblnddt ne . and eosdcdt>=unblnddt) and index(arm, 'BNT'), 1, 0); _event20=ifN(RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2) and (VAX101DT ne . or VAX102DT ne .) and (M6PD2DT=. or M6PD2DT> astdt) and (unblnddt ne . and eosdcdt>=unblnddt) and index(arm, 'BNT'), 1, 0); _event21=ifN(RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2) and vax101dt ne . and vax102dt ne . and M6PD2DT ne . and M6PD2DT le astdt and (unblnddt ne . and eosdcdt>=unblnddt) and index(arm, 'BNT'), 1, 0); _event23=ifN(RANDFL eq 'Y' and (UNBLNDDT ne . or vax201dt ne .) and index(armcd, 'PLACEBO'), 1, 0); _event24=ifN(RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2) and (VAX201DT=. and VAX202DT=.) and (unblnddt ne . and eosdcdt>=unblnddt) and index(armcd, 'PLACEBO'), 1, 0); _event25=ifN(RANDFL eq 'Y' and index(VAX201, 'BNT') and index(armcd, 'PLACEBO'), 1, 0); _event26=ifN(RANDFL eq 'Y' and index(VAX202, 'BNT') and index(armcd, 'PLACEBO'), 1, 0); _event27=ifN(RANDFL eq 'Y' and DSPHASEN=7 and EOTXDCDT ne . and dsdecodn not in (. 2) and vax201dt ne . and index(armcd, 'PLACEBO'), 1, 0); _event29=ifN(RANDFL eq 'Y' and ((DSPHASEN=7 and dsdecodn=2) ) and index(armcd, 'PLACEBO'), 1, 0); _event30=ifN(RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2) and (VAX201DT ne . or VAX202DT ne .) and ((unblnddt ne . and eosdcdt>=unblnddt) or eosdcdt=eotxdcdt) and index(armcd, 'PLACEBO'), 1, 0); _event31=ifN(RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2) and vax201dt ne . and ((vax201dt<=astdt and vax202dt eq .) or vax201dt<=astdt < vax202dt) and ((unblnddt ne . and eosdcdt>=unblnddt) or eosdcdt=eotxdcdt) and index(armcd, 'PLACEBO'), 1, 0); _event32=ifN(RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2) and vax201dt ne . and vax202dt ne . and (vax202dt <=astdt and (M1PX2DT eq . or astdt<M1PX2DT)) and ((unblnddt ne . and eosdcdt>=unblnddt) or eosdcdt=eotxdcdt) and index(armcd, 'PLACEBO'), 1, 0); _event33=ifN(RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2) and vax201dt ne . and vax202dt ne . and M1PX2DT ne . and M1PX2DT le astdt and ((unblnddt ne . and eosdcdt>=unblnddt) or eosdcdt=eotxdcdt) and index(armcd, 'PLACEBO'), 1, 0);
run;
FDA-CBER-2022-5812-0072122
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]/* Crit 1 */
data _anal1; length _EVENT1 8; set _data1; where same and _EVENT1 is not missing; _blcksrt=1; _cnt=1; _cat=1;
if _trt <=0 then
delete; output;run;
proc sort data=_anal1;
by _datasrt _blcksrt _EVENT1 _trt _cat;run;
data _temp1;
set _anal1; output;run;
proc sort data=_temp1 out=_temp91 nodupkey;
by _datasrt _blcksrt _cat _EVENT1 _trt usubjid; ;run;
proc freq data=_temp91;
format _EVENT1; tables _datasrt*_blcksrt*_cat * _EVENT1 * _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;
FDA-CBER-2022-5812-0072123
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]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;
proc transpose data=_denom1 out=_denomin1(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat; var count; id _trt;run;
data _frame1;
_datasrt=1; set _bydat1(keep=); _blcksrt=1; length _EVENT1 8; _catLabl=" "; _trt=1; _EVENT1=1; _catord=1; _cat=1; output; _trt=2; _EVENT1=1; _catord=1; _cat=1; output; _trt=3; _EVENT1=1; _catord=1; _cat=1; output;run;
proc sort data=_frame1;
by _datasrt _blcksrt _cat _EVENT1 _trt;run;
proc sort data=_pct1;
by _datasrt _blcksrt _cat _EVENT1 _trt;run;
data _pct1;
merge _frame1(in=_inframe) _pct1; by _datasrt _blcksrt _cat _EVENT1 _trt;
FDA-CBER-2022-5812-0072124
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if _inframe;
if count=. then
count=0;run;
proc sort data=_pct1;
by _datasrt _blcksrt _EVENT1;run;
data _miss1(keep=_datasrt _blcksrt _EVENT1 totcount);
set _pct1; where _EVENT1=9998; retain totcount; by _datasrt _blcksrt _EVENT1;
if first._EVENT1 then
totcount=0; totcount=totcount+count;
if last._EVENT1;
run;
data _pct1(drop=totcount);
merge _pct1 _miss1; by _datasrt _blcksrt _EVENT1;
if totcount=0 then
delete;run;
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;
proc sort data=_pct1;
by _datasrt _cat;run;
data _pct1;
if 0 then
set _basetemplate;
FDA-CBER-2022-5812-0072125
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] merge _denomin1(in=_a) _pct1;
by _datasrt _cat;
if _a;
_varname="_EVENT1 "; _vrlabel=" "; _rwlabel="Randomized ";
if _EVENT1=9998 then
do; _rwlabel="Missing "; _catord=9998; end; else if _EVENT1=9999 then do; _rwlabel="Total "; _catord=9999; end;
if _catord=. then
_catord=9997;run;
proc sort data=_pct1;
by _datasrt _blcksrt _catord _EVENT1 _trt _cat;run;
data _base1;
length _catlabl $200; set _pct1 end=eof; by _datasrt _blcksrt _catord _EVENT1 _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
FDA-CBER-2022-5812-0072126
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _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; *//* substr(_cvalue, 13, 1)='A0'x; *//* end; */
if first._EVENT1 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=0; _dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.))); _direct="TOP "; _p=2;run;
/* Crit 2 */
data _anal2; length _EVENT2 8; set _data1; where same and _EVENT2 is not missing; _blcksrt=1; _cnt=1; _cat=1;
if _trt <=0 then
delete; output;run;
proc sort data=_anal2;
by _datasrt _blcksrt _EVENT2 _trt _cat;
FDA-CBER-2022-5812-0072127
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]run;
data _temp2;
set _anal2; output;run;
proc sort data=_temp2 out=_temp92 nodupkey;
by _datasrt _blcksrt _cat _EVENT2 _trt usubjid; ;run;
proc freq data=_temp92;
format _EVENT2; tables _datasrt*_blcksrt*_cat * _EVENT2 * _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;
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;
proc transpose data=_denom2 out=_denomin2(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat; var count;
id _trt;
FDA-CBER-2022-5812-0072128
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]run;
data _frame2;
_datasrt=1; set _bydat1(keep=); _blcksrt=1; length _EVENT2 8; _catLabl=" "; _trt=1; _EVENT2=1; _catord=1; _cat=1; output; _trt=2; _EVENT2=1; _catord=1; _cat=1; output; _trt=3; _EVENT2=1; _catord=1; _cat=1; output;run;
proc sort data=_frame2;
by _datasrt _blcksrt _cat _EVENT2 _trt;run;
proc sort data=_pct2;
by _datasrt _blcksrt _cat _EVENT2 _trt;run;
data _pct2;
merge _frame2(in=_inframe) _pct2; by _datasrt _blcksrt _cat _EVENT2 _trt;
if _inframe; if count=. then
count=0;run;
proc sort data=_pct2;
by _datasrt _blcksrt _EVENT2;run;
data _miss2(keep=_datasrt _blcksrt _EVENT2 totcount);
set _pct2;
where _EVENT2=9998;
retain totcount;
by _datasrt _blcksrt _EVENT2;
if first._EVENT2 then
FDA-CBER-2022-5812-0072129
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] totcount=0;
totcount=totcount+count;
if last._EVENT2;
run;
data _pct2(drop=totcount);
merge _pct2 _miss2;
by _datasrt _blcksrt _EVENT2;
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=1;
run;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;
_varname="_EVENT2 ";
_vrlabel=" ";
_rwlabel="Not vaccinated ";
if _EVENT2=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT2=9999 then
do;
_rwlabel="Total ";
_catord=9999;
FDA-CBER-2022-5812-0072130
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct2;
by _datasrt _blcksrt _catord _EVENT2 _trt _cat;
run;data _base2;
length _catlabl $200;
set _pct2 end=eof;
by _datasrt _blcksrt _catord _EVENT2 _trt _cat;
retain _rowsrt 1 _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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT2 then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
FDA-CBER-2022-5812-0072131
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=0;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 3 */
data _anal3;
length _EVENT3 8;
set _data1;
where same and _EVENT3 is not missing;
_blcksrt=1;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal3;
by _datasrt _blcksrt _EVENT3 _trt _cat;
run;data _temp3;
set _anal3;
output;
run;proc sort data=_temp3 out=_temp93 nodupkey;
by _datasrt _blcksrt _cat _EVENT3 _trt usubjid;
;
run;proc freq data=_temp93;
format _EVENT3;
tables _datasrt*_blcksrt*_cat * _EVENT3 * _trt / sparse norow nocol nopercent
out=_pct3(drop=percent);
run;
FDA-CBER-2022-5812-0072132
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]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;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;proc transpose data=_denom3 out=_denomin3(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame3;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=1;
length _EVENT3 8;
_catLabl=" ";
_trt=1;
_EVENT3=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT3=1;
_catord=1;
_cat=1;
output;
FDA-CBER-2022-5812-0072133
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _trt=3;
_EVENT3=1;
_catord=1;
_cat=1;
output;
run;
proc sort data=_frame3;
by _datasrt _blcksrt _cat _EVENT3 _trt;
run;proc sort data=_pct3;
by _datasrt _blcksrt _cat _EVENT3 _trt;
run;data _pct3;
merge _frame3(in=_inframe) _pct3;
by _datasrt _blcksrt _cat _EVENT3 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct3;
by _datasrt _blcksrt _EVENT3;
run;data _miss3(keep=_datasrt _blcksrt _EVENT3 totcount);
set _pct3;
where _EVENT3=9998;
retain totcount;
by _datasrt _blcksrt _EVENT3;
if first._EVENT3 then
totcount=0;
totcount=totcount+count;
if last._EVENT3;
run;data _pct3(drop=totcount);
merge _pct3 _miss3;
by _datasrt _blcksrt _EVENT3;
if totcount=0 then
delete;
run;proc sort data=_denomf3;
by _datasrt _cat;
run;
FDA-CBER-2022-5812-0072134
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_denomin3;
by _datasrt _cat;
run;
data _denomin3;
merge _denomf3(in=_inframe) _denomin3;
by _datasrt _cat;
if _inframe;
_blcksrt=1;
run;proc sort data=_pct3;
by _datasrt _cat;
run;data _pct3;
if 0 then
set _basetemplate;
merge _denomin3(in=_a) _pct3;
by _datasrt _cat;
if _a;
_varname="_EVENT3 ";
_vrlabel="Original blinded placebo-controlled follow-up period ";
_rwlabel="Vaccinated ";
if _EVENT3=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT3=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct3;
by _datasrt _blcksrt _catord _EVENT3 _trt _cat;
run;data _base3;
length _catlabl $200;
set _pct3 end=eof;
by _datasrt _blcksrt _catord _EVENT3 _trt _cat;
retain _rowsrt 2 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
FDA-CBER-2022-5812-0072135
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT3 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=2;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
FDA-CBER-2022-5812-0072136
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _p=2;
run;
/* Crit 4 */
data _anal4;
length _EVENT4 8;
set _data1;
where same and _EVENT4 is not missing;
_blcksrt=1;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal4;
by _datasrt _blcksrt _EVENT4 _trt _cat;
run;data _temp4;
set _anal4;
output;
run;proc sort data=_temp4 out=_temp94 nodupkey;
by _datasrt _blcksrt _cat _EVENT4 _trt usubjid;
run;proc freq data=_temp94;
format _EVENT4;
tables _datasrt*_blcksrt*_cat * _EVENT4 * _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;
FDA-CBER-2022-5812-0072137
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]run;
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;
proc transpose data=_denom4 out=_denomin4(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame4;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=1;
length _EVENT4 8;
_catLabl=" ";
_trt=1;
_EVENT4=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT4=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT4=1;
_catord=1;
_cat=1;
output;
run;proc sort data=_frame4;
by _datasrt _blcksrt _cat _EVENT4 _trt;
run;proc sort data=_pct4;
by _datasrt _blcksrt _cat _EVENT4 _trt;
run;data _pct4;
merge _frame4(in=_inframe) _pct4;
by _datasrt _blcksrt _cat _EVENT4 _trt;
FDA-CBER-2022-5812-0072138
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if _inframe;
if count=. then
count=0;
run;
proc sort data=_pct4;
by _datasrt _blcksrt _EVENT4;
run;data _miss4(keep=_datasrt _blcksrt _EVENT4 totcount);
set _pct4;
where _EVENT4=9998;
retain totcount;
by _datasrt _blcksrt _EVENT4;
if first._EVENT4 then
totcount=0;
totcount=totcount+count;
if last._EVENT4;
run;data _pct4(drop=totcount);
merge _pct4 _miss4;
by _datasrt _blcksrt _EVENT4;
if totcount=0 then
delete;
run;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=1;
run;proc sort data=_pct4;
by _datasrt _cat;
run;data _pct4;
if 0 then
FDA-CBER-2022-5812-0072139
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] set _basetemplate;
merge _denomin4(in=_a) _pct4;
by _datasrt _cat;
if _a;
_varname="_EVENT4 ";
_vrlabel=" ";
_rwlabel="Dose 1 ";
if _EVENT4=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT4=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct4;
by _datasrt _blcksrt _catord _EVENT4 _trt _cat;
run;data _base4;
length _catlabl $200;
set _pct4 end=eof;
by _datasrt _blcksrt _catord _EVENT4 _trt _cat;
retain _rowsrt 3 _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;
FDA-CBER-2022-5812-0072140
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] 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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT4 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=4;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 5 */
data _anal5;
length _EVENT5 8;
set _data1;
where same and _EVENT5 is not missing;
_blcksrt=1;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal5;
FDA-CBER-2022-5812-0072141
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] by _datasrt _blcksrt _EVENT5 _trt _cat;
run;
data _temp5;
set _anal5;
output;
run;proc sort data=_temp5 out=_temp95 nodupkey;
by _datasrt _blcksrt _cat _EVENT5 _trt usubjid;
;
run;proc freq data=_temp95;
format _EVENT5;
tables _datasrt*_blcksrt*_cat * _EVENT5 * _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';
_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;
FDA-CBER-2022-5812-0072142
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] id _trt;
run;
data _frame5;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=1;
length _EVENT5 8;
_catLabl=" ";
_trt=1;
_EVENT5=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT5=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT5=1;
_catord=1;
_cat=1;
output;
run;proc sort data=_frame5;
by _datasrt _blcksrt _cat _EVENT5 _trt;
run;proc sort data=_pct5;
by _datasrt _blcksrt _cat _EVENT5 _trt;
run;data _pct5;
merge _frame5(in=_inframe) _pct5;
by _datasrt _blcksrt _cat _EVENT5 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct5;
by _datasrt _blcksrt _EVENT5;
run;data _miss5(keep=_datasrt _blcksrt _EVENT5 totcount);
set _pct5;
where _EVENT5=9998;
retain totcount;
by _datasrt _blcksrt _EVENT5;
FDA-CBER-2022-5812-0072143
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if first._EVENT5 then
totcount=0;
totcount=totcount+count;
if last._EVENT5;
run;
data _pct5(drop=totcount);
merge _pct5 _miss5;
by _datasrt _blcksrt _EVENT5;
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=1;
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="_EVENT5 ";
_vrlabel=" ";
_rwlabel="Dose 2 ";
if _EVENT5=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT5=9999 then
do;
_rwlabel="Total ";
FDA-CBER-2022-5812-0072144
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct5;
by _datasrt _blcksrt _catord _EVENT5 _trt _cat;
run;data _base5;
length _catlabl $200;
set _pct5 end=eof;
by _datasrt _blcksrt _catord _EVENT5 _trt _cat;
retain _rowsrt 4 _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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT5 then
do;
_rowsrt=_rowsrt + 1;
FDA-CBER-2022-5812-0072145
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=4;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 6 */
data _anal6;
length _EVENT6 8;
set _data1;
where same and _EVENT6 is not missing;
_blcksrt=2;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal6;
by _datasrt _blcksrt _EVENT6 _trt _cat;
run;data _temp6;
set _anal6;
output;
run;proc sort data=_temp6 out=_temp96 nodupkey;
by _datasrt _blcksrt _cat _EVENT6 _trt usubjid;
run;proc freq data=_temp96;
format _EVENT6;
tables _datasrt*_blcksrt*_cat * _EVENT6 * _trt / sparse norow nocol nopercent
out=_pct6(drop=percent);
run;
FDA-CBER-2022-5812-0072146
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 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;data _frame6;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=2;
length _EVENT6 8;
_catLabl=" ";
_trt=1;
_EVENT6=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT6=1;
_catord=1;
_cat=1;
FDA-CBER-2022-5812-0072147
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] output;
_trt=3;
_EVENT6=1;
_catord=1;
_cat=1;
output;
run;
proc sort data=_frame6;
by _datasrt _blcksrt _cat _EVENT6 _trt;
run;proc sort data=_pct6;
by _datasrt _blcksrt _cat _EVENT6 _trt;
run;data _pct6;
merge _frame6(in=_inframe) _pct6;
by _datasrt _blcksrt _cat _EVENT6 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct6;
by _datasrt _blcksrt _EVENT6;
run;data _miss6(keep=_datasrt _blcksrt _EVENT6 totcount);
set _pct6;
where _EVENT6=9998;
retain totcount;
by _datasrt _blcksrt _EVENT6;
if first._EVENT6 then
totcount=0;
totcount=totcount+count;
if last._EVENT6;
run;data _pct6(drop=totcount);
merge _pct6 _miss6;
by _datasrt _blcksrt _EVENT6;
if totcount=0 then
delete;
run;proc sort data=_denomf6;
by _datasrt _cat;
run;
FDA-CBER-2022-5812-0072148
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_denomin6;
by _datasrt _cat;
run;
data _denomin6;
merge _denomf6(in=_inframe) _denomin6;
by _datasrt _cat;
if _inframe;
_blcksrt=2;
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="_EVENT6 ";
_vrlabel=" ";
_rwlabel="Discontinued from original blinded placebo-controlled vaccination period~{super c}";
if _EVENT6=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT6=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct6;
by _datasrt _blcksrt _catord _EVENT6 _trt _cat;
run;data _base6;
length _catlabl $200;
set _pct6 end=eof;
by _datasrt _blcksrt _catord _EVENT6 _trt _cat;
retain _rowsrt 0 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
FDA-CBER-2022-5812-0072149
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] 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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT6 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=2;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
FDA-CBER-2022-5812-0072150
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _direct="TOP ";
_p=2;
run;
/* Crit 7 */
data _anal7;
length DSDECODN 8;
set _data1;
where same and DSDECODN is not missing;
_blcksrt=2;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal7;
by _datasrt _blcksrt DSDECODN _trt _cat;
run;data _temp7;
set _anal7;
output;
run;proc sort data=_temp7 out=_temp97 nodupkey;
by _datasrt _blcksrt _cat DSDECODN _trt usubjid;
where RANDFL eq 'Y' and DSPHASEN=26 and EOTDCDT ne . and dsdecodn not in (. 2)
and (VAX101DT ne . or VAX102DT ne .) and (unblnddt=. or eotdcdt<unblnddt);
run;proc freq data=_temp97;
format DSDECODN;
tables _datasrt*_blcksrt*_cat * DSDECODN * _trt / sparse norow nocol nopercent
out=_pct7(drop=percent);
run;proc sort data=_anal7 out=_denom7(keep=_datasrt _cat) nodupkey;
where RANDFL eq 'Y' and DSPHASEN=26 and EOTDCDT ne . and dsdecodn not in (. 2)
and (VAX101DT ne . or VAX102DT ne .) and (unblnddt=. or eotdcdt<unblnddt);
by _datasrt _cat;
run;data _denom7;
set _denom7;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
FDA-CBER-2022-5812-0072151
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] output;
_trt=3;
count=&_trt3.;
output;
run;
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;proc transpose data=_denom7 out=_denomin7(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;proc sort data=_pct7 out=_expv7 (keep=_datasrt _blcksrt DSDECODN) nodupkey;
by _datasrt _blcksrt DSDECODN;
run;proc sort data=_expv7;
by _datasrt _blcksrt DSDECODN;
run;data _frame7;
set _expv7;
by _datasrt _blcksrt DSDECODN;
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=_frame7;
by _datasrt _blcksrt _cat DSDECODN _trt;
run;
FDA-CBER-2022-5812-0072152
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_pct7;
by _datasrt _blcksrt _cat DSDECODN _trt;
run;
data _pct7;
merge _frame7(in=_inframe) _pct7;
by _datasrt _blcksrt _cat DSDECODN _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct7;
by _datasrt _blcksrt DSDECODN;
run;data _miss7(keep=_datasrt _blcksrt DSDECODN totcount);
set _pct7;
where DSDECODN=9998;
retain totcount;
by _datasrt _blcksrt DSDECODN;
if first.DSDECODN then
totcount=0;
totcount=totcount+count;
if last.DSDECODN;
run;data _pct7(drop=totcount);
merge _pct7 _miss7;
by _datasrt _blcksrt DSDECODN;
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=2;
run;
FDA-CBER-2022-5812-0072153
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]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="DSDECODN ";
_vrlabel="Reason for discontinuation ";
_rwlabel=put(DSDECODN, dsdecod.);
if DSDECODN=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if DSDECODN=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct7;
by _datasrt _blcksrt _catord DSDECODN _trt _cat;
run;data _base7;
length _catlabl $200;
set _pct7 end=eof;
by _datasrt _blcksrt _catord DSDECODN _trt _cat;
retain _rowsrt 1 _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;
FDA-CBER-2022-5812-0072154
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 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.DSDECODN 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=8;
_dptindt=4;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 8 */
data _anal8;
length _EVENT8 8;
set _data1;
where same and _EVENT8 is not missing;
FDA-CBER-2022-5812-0072155
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _blcksrt=3;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal8;
by _datasrt _blcksrt _EVENT8 _trt _cat;
run;data _temp8;
set _anal8;
output;
run;proc sort data=_temp8 out=_temp98 nodupkey;
by _datasrt _blcksrt _cat _EVENT8 _trt usubjid;
run;proc freq data=_temp98;
format _EVENT8;
tables _datasrt*_blcksrt*_cat * _EVENT8 * _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;data _denomf8;
_datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
_trt2=0;
FDA-CBER-2022-5812-0072156
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;
proc transpose data=_denom8 out=_denomin8(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame8;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=3;
length _EVENT8 8;
_catLabl=" ";
_trt=1;
_EVENT8=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT8=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT8=1;
_catord=1;
_cat=1;
output;
run;proc sort data=_frame8;
by _datasrt _blcksrt _cat _EVENT8 _trt;
run;proc sort data=_pct8;
by _datasrt _blcksrt _cat _EVENT8 _trt;
run;data _pct8;
merge _frame8(in=_inframe) _pct8;
by _datasrt _blcksrt _cat _EVENT8 _trt;
if _inframe;
if count=. then
count=0;
run;
proc sort data=_pct8;
FDA-CBER-2022-5812-0072157
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] by _datasrt _blcksrt _EVENT8;
run;
data _miss8(keep=_datasrt _blcksrt _EVENT8 totcount);
set _pct8;
where _EVENT8=9998;
retain totcount;
by _datasrt _blcksrt _EVENT8;
if first._EVENT8 then
totcount=0;
totcount=totcount+count;
if last._EVENT8;
run;data _pct8(drop=totcount);
merge _pct8 _miss8;
by _datasrt _blcksrt _EVENT8;
if totcount=0 then
delete;
run;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=3;
run;proc sort data=_pct8;
by _datasrt _cat;
run;data _pct8;
if 0 then
set _basetemplate;
merge _denomin8(in=_a) _pct8;
by _datasrt _cat;
if _a;
_varname="_EVENT8 ";
_vrlabel=" ";
_rwlabel="Unblinded before 1-month post(*ESC*){unicode 2013}Dose 2 visit ";
FDA-CBER-2022-5812-0072158
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if _EVENT8=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT8=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct8;
by _datasrt _blcksrt _catord _EVENT8 _trt _cat;
run;data _base8;
length _catlabl $200;
set _pct8 end=eof;
by _datasrt _blcksrt _catord _EVENT8 _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;
FDA-CBER-2022-5812-0072159
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]/* if length(_cvalue) < 13 then */
/*
do; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT8 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=2;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 9 */
data _anal9;
length _EVENT9 8;
set _data1;
where same and _EVENT9 is not missing;
_blcksrt=3;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal9;
by _datasrt _blcksrt _EVENT9 _trt _cat;
run;data _temp9;
set _anal9;
output;
run;
FDA-CBER-2022-5812-0072160
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_temp9 out=_temp99 nodupkey;
by _datasrt _blcksrt _cat _EVENT9 _trt usubjid;
;
run;
proc freq data=_temp99;
format _EVENT9;
tables _datasrt*_blcksrt*_cat * _EVENT9 * _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;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;proc transpose data=_denom9 out=_denomin9(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame9;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=3;
length _EVENT9 8;
FDA-CBER-2022-5812-0072161
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _catLabl=" ";
_trt=1;
_EVENT9=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT9=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT9=1;
_catord=1;
_cat=1;
output;
run;
proc sort data=_frame9;
by _datasrt _blcksrt _cat _EVENT9 _trt;
run;proc sort data=_pct9;
by _datasrt _blcksrt _cat _EVENT9 _trt;
run;data _pct9;
merge _frame9(in=_inframe) _pct9;
by _datasrt _blcksrt _cat _EVENT9 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct9;
by _datasrt _blcksrt _EVENT9;
run;data _miss9(keep=_datasrt _blcksrt _EVENT9 totcount);
set _pct9;
where _EVENT9=9998;
retain totcount;
by _datasrt _blcksrt _EVENT9;
if first._EVENT9 then
totcount=0;
totcount=totcount+count;
if last._EVENT9;
run;
data _pct9(drop=totcount);
FDA-CBER-2022-5812-0072162
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] merge _pct9 _miss9;
by _datasrt _blcksrt _EVENT9;
if totcount=0 then
delete;
run;
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=3;
run;proc sort data=_pct9;
by _datasrt _cat;
run;data _pct9;
if 0 then
set _basetemplate;
merge _denomin9(in=_a) _pct9;
by _datasrt _cat;
if _a;
_varname="_EVENT9 ";
_vrlabel=" ";
_rwlabel="Completed 1-month post(*ESC*){unicode 2013}Dose 2 visit ";
if _EVENT9=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT9=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct9;
FDA-CBER-2022-5812-0072163
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] by _datasrt _blcksrt _catord _EVENT9 _trt _cat;
run;
data _base9;
length _catlabl $200;
set _pct9 end=eof;
by _datasrt _blcksrt _catord _EVENT9 _trt _cat;
retain _rowsrt 1 _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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT9 then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
FDA-CBER-2022-5812-0072164
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=2;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 10 */
data _anal10;
length _EVENT10 8;
set _data1;
where same and _EVENT10 is not missing;
_blcksrt=4;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal10;
by _datasrt _blcksrt _EVENT10 _trt _cat;
run;data _temp10;
set _anal10;
output;
run;proc sort data=_temp10 out=_temp910 nodupkey;
by _datasrt _blcksrt _cat _EVENT10 _trt usubjid;
run;proc freq data=_temp910;
format _EVENT10;
tables _datasrt*_blcksrt*_cat * _EVENT10 * _trt / sparse norow nocol nopercent
out=_pct10(drop=percent);
run;proc sort data=_anal10 out=_denom10(keep=_datasrt _cat) nodupkey;
by _datasrt _cat;
run;data _denom10;
set _denom10;
by _datasrt _cat;
FDA-CBER-2022-5812-0072165
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;
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;data _frame10;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=4;
length _EVENT10 8;
_catLabl=" ";
_trt=1;
_EVENT10=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT10=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT10=1;
_catord=1;
_cat=1;
output;
run;
proc sort data=_frame10;
FDA-CBER-2022-5812-0072166
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] by _datasrt _blcksrt _cat _EVENT10 _trt;
run;
proc sort data=_pct10;
by _datasrt _blcksrt _cat _EVENT10 _trt;
run;data _pct10;
merge _frame10(in=_inframe) _pct10;
by _datasrt _blcksrt _cat _EVENT10 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct10;
by _datasrt _blcksrt _EVENT10;
run;data _miss10(keep=_datasrt _blcksrt _EVENT10 totcount);
set _pct10;
where _EVENT10=9998;
retain totcount;
by _datasrt _blcksrt _EVENT10;
if first._EVENT10 then
totcount=0;
totcount=totcount+count;
if last._EVENT10;
run;data _pct10(drop=totcount);
merge _pct10 _miss10;
by _datasrt _blcksrt _EVENT10;
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;
FDA-CBER-2022-5812-0072167
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if _inframe;
_blcksrt=4;
run;
proc sort data=_pct10;
by _datasrt _cat;
run;data _pct10;
if 0 then
set _basetemplate;
merge _denomin10(in=_a) _pct10;
by _datasrt _cat;
if _a;
_varname="_EVENT10 ";
_vrlabel=" ";
_rwlabel="Withdrawn from the study ";
if _EVENT10=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT10=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct10;
by _datasrt _blcksrt _catord _EVENT10 _trt _cat;
run;data _base10;
length _catlabl $200;
set _pct10 end=eof;
by _datasrt _blcksrt _catord _EVENT10 _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-2022-5812-0072168
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT10 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=2;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 11 */
data _anal11;
length _EVENT11 8;
set _data1;
where same and _EVENT11 is not missing;
FDA-CBER-2022-5812-0072169
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _blcksrt=4;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal11;
by _datasrt _blcksrt _EVENT11 _trt _cat;
run;data _temp11;
set _anal11;
output;
run;proc sort data=_temp11 out=_temp911 nodupkey;
by _datasrt _blcksrt _cat _EVENT11 _trt usubjid;
;
run;proc freq data=_temp911;
format _EVENT11;
tables _datasrt*_blcksrt*_cat * _EVENT11 * _trt / sparse norow nocol nopercent
out=_pct11(drop=percent);
run;proc sort data=_anal11 out=_denom11(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom11;
set _denom11;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf11;
_datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
FDA-CBER-2022-5812-0072170
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;
proc transpose data=_denom11 out=_denomin11(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame11;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=4;
length _EVENT11 8;
_catLabl=" ";
_trt=1;
_EVENT11=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT11=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT11=1;
_catord=1;
_cat=1;
output;
run;proc sort data=_frame11;
by _datasrt _blcksrt _cat _EVENT11 _trt;
run;proc sort data=_pct11;
by _datasrt _blcksrt _cat _EVENT11 _trt;
run;data _pct11;
merge _frame11(in=_inframe) _pct11;
by _datasrt _blcksrt _cat _EVENT11 _trt;
if _inframe;
if count=. then
count=0;
run;
FDA-CBER-2022-5812-0072171
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_pct11;
by _datasrt _blcksrt _EVENT11;
run;
data _miss11(keep=_datasrt _blcksrt _EVENT11 totcount);
set _pct11;
where _EVENT11=9998;
retain totcount;
by _datasrt _blcksrt _EVENT11;
if first._EVENT11 then
totcount=0;
totcount=totcount+count;
if last._EVENT11;
run;data _pct11(drop=totcount);
merge _pct11 _miss11;
by _datasrt _blcksrt _EVENT11;
if totcount=0 then
delete;
run;proc sort data=_denomf11;
by _datasrt _cat;
run;proc sort data=_denomin11;
by _datasrt _cat;
run;data _denomin11;
merge _denomf11(in=_inframe) _denomin11;
by _datasrt _cat;
if _inframe;
_blcksrt=4;
run;proc sort data=_pct11;
by _datasrt _cat;
run;data _pct11;
if 0 then
set _basetemplate;
merge _denomin11(in=_a) _pct11;
by _datasrt _cat;
if _a;
_varname="_EVENT11 ";
_vrlabel=" ";
FDA-CBER-2022-5812-0072172
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _rwlabel="Withdrawn after Dose 1 and before Dose 2 ";
if _EVENT11=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT11=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct11;
by _datasrt _blcksrt _catord _EVENT11 _trt _cat;
run;data _base11;
length _catlabl $200;
set _pct11 end=eof;
by _datasrt _blcksrt _catord _EVENT11 _trt _cat;
retain _rowsrt 1 _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)";
FDA-CBER-2022-5812-0072173
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _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._EVENT11 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=4;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 12 */
data _anal12;
length _EVENT12 8;
set _data1;
where same and _EVENT12 is not missing;
_blcksrt=4;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal12;
by _datasrt _blcksrt _EVENT12 _trt _cat;
FDA-CBER-2022-5812-0072174
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]run;
data _temp12;
set _anal12;
output;
run;
proc sort data=_temp12 out=_temp912 nodupkey;
by _datasrt _blcksrt _cat _EVENT12 _trt usubjid;
run;proc freq data=_temp912;
format _EVENT12;
tables _datasrt*_blcksrt*_cat * _EVENT12 * _trt / sparse norow nocol nopercent
out=_pct12(drop=percent);
run;proc sort data=_anal12 out=_denom12(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom12;
set _denom12;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf12;
_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=_denom12 out=_denomin12(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;
FDA-CBER-2022-5812-0072175
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _frame12;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=4;
length _EVENT12 8;
_catLabl=" ";
_trt=1;
_EVENT12=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT12=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT12=1;
_catord=1;
_cat=1;
output;
run;
proc sort data=_frame12;
by _datasrt _blcksrt _cat _EVENT12 _trt;
run;proc sort data=_pct12;
by _datasrt _blcksrt _cat _EVENT12 _trt;
run;data _pct12;
merge _frame12(in=_inframe) _pct12;
by _datasrt _blcksrt _cat _EVENT12 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct12;
by _datasrt _blcksrt _EVENT12;
run;data _miss12(keep=_datasrt _blcksrt _EVENT12 totcount);
set _pct12;
where _EVENT12=9998;
retain totcount;
by _datasrt _blcksrt _EVENT12;
if first._EVENT12 then
totcount=0;
FDA-CBER-2022-5812-0072176
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] totcount=totcount+count;
if last._EVENT12;
run;
data _pct12(drop=totcount);
merge _pct12 _miss12;
by _datasrt _blcksrt _EVENT12;
if totcount=0 then
delete;
run;proc sort data=_denomf12;
by _datasrt _cat;
run;proc sort data=_denomin12;
by _datasrt _cat;
run;data _denomin12;
merge _denomf12(in=_inframe) _denomin12;
by _datasrt _cat;
if _inframe;
_blcksrt=4;
run;proc sort data=_pct12;
by _datasrt _cat;
run;data _pct12;
if 0 then
set _basetemplate;
merge _denomin12(in=_a) _pct12;
by _datasrt _cat;
if _a;
_varname="_EVENT12 ";
_vrlabel=" ";
_rwlabel="Withdrawn after Dose 2 and before 1-month post(*ESC*){unicode 2013}Dose 2 visit ";
if _EVENT12=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT12=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
FDA-CBER-2022-5812-0072177
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if _catord=. then
_catord=9997;
run;
proc sort data=_pct12;
by _datasrt _blcksrt _catord _EVENT12 _trt _cat;
run;data _base12;
length _catlabl $200;
set _pct12 end=eof;
by _datasrt _blcksrt _catord _EVENT12 _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.);
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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT12 then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
FDA-CBER-2022-5812-0072178
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=4;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 13 */
data _anal13;
length _EVENT13 8;
set _data1;
where same and _EVENT13 is not missing;
_blcksrt=4;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal13;
by _datasrt _blcksrt _EVENT13 _trt _cat;
run;data _temp13;
set _anal13;
output;
run;proc sort data=_temp13 out=_temp913 nodupkey;
by _datasrt _blcksrt _cat _EVENT13 _trt usubjid;
;
run;proc freq data=_temp913;
format _EVENT13;
tables _datasrt*_blcksrt*_cat * _EVENT13 * _trt / sparse norow nocol nopercent
out=_pct13(drop=percent);
run;
FDA-CBER-2022-5812-0072179
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_anal13 out=_denom13(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;
data _denom13;
set _denom13;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf13;
_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=_denom13 out=_denomin13(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame13;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=4;
length _EVENT13 8;
_catLabl=" ";
_trt=1;
_EVENT13=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT13=1;
_catord=1;
_cat=1;
output;
FDA-CBER-2022-5812-0072180
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _trt=3;
_EVENT13=1;
_catord=1;
_cat=1;
output;
run;
proc sort data=_frame13;
by _datasrt _blcksrt _cat _EVENT13 _trt;
run;proc sort data=_pct13;
by _datasrt _blcksrt _cat _EVENT13 _trt;
run;data _pct13;
merge _frame13(in=_inframe) _pct13;
by _datasrt _blcksrt _cat _EVENT13 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct13;
by _datasrt _blcksrt _EVENT13;
run;data _miss13(keep=_datasrt _blcksrt _EVENT13 totcount);
set _pct13;
where _EVENT13=9998;
retain totcount;
by _datasrt _blcksrt _EVENT13;
if first._EVENT13 then
totcount=0;
totcount=totcount+count;
if last._EVENT13;
run;data _pct13(drop=totcount);
merge _pct13 _miss13;
by _datasrt _blcksrt _EVENT13;
if totcount=0 then
delete;
run;proc sort data=_denomf13;
by _datasrt _cat;
run;
FDA-CBER-2022-5812-0072181
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_denomin13;
by _datasrt _cat;
run;
data _denomin13;
merge _denomf13(in=_inframe) _denomin13;
by _datasrt _cat;
if _inframe;
_blcksrt=4;
run;proc sort data=_pct13;
by _datasrt _cat;
run;data _pct13;
if 0 then
set _basetemplate;
merge _denomin13(in=_a) _pct13;
by _datasrt _cat;
if _a;
_varname="_EVENT13 ";
_vrlabel=" ";
_rwlabel="Withdrawn after 1-month post(*ESC*){unicode 2013}Dose 2 visit ";
if _EVENT13=9998 then
do; _rwlabel="Missing "; _catord=9998; end; else if _EVENT13=9999 then do; _rwlabel="Total "; _catord=9999; end;
if _catord=. then
_catord=9997;run;
proc sort data=_pct13;
by _datasrt _blcksrt _catord _EVENT13 _trt _cat;run;
data _base13;
length _catlabl $200; set _pct13 end=eof; by _datasrt _blcksrt _catord _EVENT13 _trt _cat; retain _rowsrt 3 _rowmax 0; array _trtcnt(*) _trt1-_trt4; drop _rowmax _cpct;
length _cpct $100;
FDA-CBER-2022-5812-0072182
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _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; *//* substr(_cvalue, 13, 1)='A0'x; *//* end; */
if first._EVENT13 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=4;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
FDA-CBER-2022-5812-0072183
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _p=2;
run;
/* Crit 14 */
data _anal14;
length DSDECODN 8;
set _data1;
where same and DSDECODN is not missing;
_blcksrt=4;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal14;
by _datasrt _blcksrt DSDECODN _trt _cat;
run;data _temp14;
set _anal14;
output;
run;proc sort data=_temp14 out=_temp914 nodupkey;
by _datasrt _blcksrt _cat DSDECODN _trt usubjid;
where RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2)
and (VAX101DT ne . or VAX102DT ne .) and (unblnddt=. or eosdcdt<unblnddt) and
EOSDCDT ne EOTXDCDT;
run;proc freq data=_temp914;
format DSDECODN;
tables _datasrt*_blcksrt*_cat * DSDECODN * _trt / sparse norow nocol nopercent
out=_pct14(drop=percent);
run;proc sort data=_anal14 out=_denom14(keep=_datasrt _cat) nodupkey;
where RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2)
and (VAX101DT ne . or VAX102DT ne .) and (unblnddt=. or eosdcdt<unblnddt) and
EOSDCDT ne EOTXDCDT;
by _datasrt _cat;
run;data _denom14;
set _denom14;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
FDA-CBER-2022-5812-0072184
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;
data _denomf14;
_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=_denom14 out=_denomin14(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;proc sort data=_pct14 out=_expv14 (keep=_datasrt _blcksrt DSDECODN) nodupkey;
by _datasrt _blcksrt DSDECODN;
run;proc sort data=_expv14;
by _datasrt _blcksrt DSDECODN;
run;data _frame14;
set _expv14;
by _datasrt _blcksrt DSDECODN;
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=_frame14;
by _datasrt _blcksrt _cat DSDECODN _trt;
run;
FDA-CBER-2022-5812-0072185
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_pct14;
by _datasrt _blcksrt _cat DSDECODN _trt;
run;
data _pct14;
merge _frame14(in=_inframe) _pct14;
by _datasrt _blcksrt _cat DSDECODN _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct14;
by _datasrt _blcksrt DSDECODN;
run;data _miss14(keep=_datasrt _blcksrt DSDECODN totcount);
set _pct14;
where DSDECODN=9998;
retain totcount;
by _datasrt _blcksrt DSDECODN;
if first.DSDECODN then
totcount=0;
totcount=totcount+count;
if last.DSDECODN;
run;data _pct14(drop=totcount);
merge _pct14 _miss14;
by _datasrt _blcksrt DSDECODN;
if totcount=0 then
delete;
run;proc sort data=_denomf14;
by _datasrt _cat;
run;proc sort data=_denomin14;
by _datasrt _cat;
run;data _denomin14;
merge _denomf14(in=_inframe) _denomin14;
by _datasrt _cat;
if _inframe;
_blcksrt=4;
FDA-CBER-2022-5812-0072186
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]run;
proc sort data=_pct14;
by _datasrt _cat;
run;
data _pct14;
if 0 then
set _basetemplate;
merge _denomin14(in=_a) _pct14;
by _datasrt _cat;
if _a;
_varname="DSDECODN ";
_vrlabel="Reason for withdrawal from the study ";
_rwlabel=put(DSDECODN, dsdecod.);
if DSDECODN=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if DSDECODN=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct14;
by _datasrt _blcksrt _catord DSDECODN _trt _cat;
run;data _base14;
length _catlabl $200;
set _pct14 end=eof;
by _datasrt _blcksrt _catord DSDECODN _trt _cat;
retain _rowsrt 4 _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;
FDA-CBER-2022-5812-0072187
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 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.DSDECODN 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=8;
_dptindt=4;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 15 */
data _anal15;
length _EVENT15 8;
set _data1;
FDA-CBER-2022-5812-0072188
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] where same and _EVENT15 is not missing;
_blcksrt=5;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal15;
by _datasrt _blcksrt _EVENT15 _trt _cat;
run;data _temp15;
set _anal15;
output;
run;proc sort data=_temp15 out=_temp915 nodupkey;
by _datasrt _blcksrt _cat _EVENT15 _trt usubjid;
;
run;proc freq data=_temp915;
format _EVENT15;
tables _datasrt*_blcksrt*_cat * _EVENT15 * _trt / sparse norow nocol nopercent
out=_pct15(drop=percent);
run;proc sort data=_anal15 out=_denom15(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom15;
set _denom15;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf15;
_datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
FDA-CBER-2022-5812-0072189
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _trt1=0;
_trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;
proc transpose data=_denom15 out=_denomin15(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame15;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=5;
length _EVENT15 8;
_catLabl=" ";
_trt=1;
_EVENT15=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT15=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT15=1;
_catord=1;
_cat=1;
output;
run;proc sort data=_frame15;
by _datasrt _blcksrt _cat _EVENT15 _trt;
run;proc sort data=_pct15;
by _datasrt _blcksrt _cat _EVENT15 _trt;
run;data _pct15;
merge _frame15(in=_inframe) _pct15;
by _datasrt _blcksrt _cat _EVENT15 _trt;
if _inframe;
if count=. then
count=0;
run;
FDA-CBER-2022-5812-0072190
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_pct15;
by _datasrt _blcksrt _EVENT15;
run;
data _miss15(keep=_datasrt _blcksrt _EVENT15 totcount);
set _pct15;
where _EVENT15=9998;
retain totcount;
by _datasrt _blcksrt _EVENT15;
if first._EVENT15 then
totcount=0;
totcount=totcount+count;
if last._EVENT15;
run;data _pct15(drop=totcount);
merge _pct15 _miss15;
by _datasrt _blcksrt _EVENT15;
if totcount=0 then
delete;
run;proc sort data=_denomf15;
by _datasrt _cat;
run;proc sort data=_denomin15;
by _datasrt _cat;
run;data _denomin15;
merge _denomf15(in=_inframe) _denomin15;
by _datasrt _cat;
if _inframe;
_blcksrt=5;
run;proc sort data=_pct15;
by _datasrt _cat;
run;data _pct15;
if 0 then
set _basetemplate;
merge _denomin15(in=_a) _pct15;
by _datasrt _cat;
if _a;
_varname="_EVENT15 ";
FDA-CBER-2022-5812-0072191
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _vrlabel="Open-label follow-up period ";
_rwlabel="Originally randomized to BNT162b2 ";
if _EVENT15=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT15=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct15;
by _datasrt _blcksrt _catord _EVENT15 _trt _cat;
run;data _base15;
length _catlabl $200;
set _pct15 end=eof;
by _datasrt _blcksrt _catord _EVENT15 _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;
FDA-CBER-2022-5812-0072192
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] end;
end;
/*
if length(_cvalue) < 13 then */
/*
do; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT15 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=2;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 16 */
data _anal16;
length _EVENT16 8;
set _data1;
where same and _EVENT16 is not missing;
_blcksrt=5;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal16;
by _datasrt _blcksrt _EVENT16 _trt _cat;
run;data _temp16;
set _anal16;
output;
FDA-CBER-2022-5812-0072193
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]run;
proc sort data=_temp16 out=_temp916 nodupkey;
by _datasrt _blcksrt _cat _EVENT16 _trt usubjid;
;
run;
proc freq data=_temp916;
format _EVENT16;
tables _datasrt*_blcksrt*_cat * _EVENT16 * _trt / sparse norow nocol nopercent
out=_pct16(drop=percent);
run;proc sort data=_anal16 out=_denom16(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom16;
set _denom16;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf16;
_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=_denom16 out=_denomin16(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame16;
_datasrt=1;
set _bydat1(keep=);
FDA-CBER-2022-5812-0072194
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _blcksrt=5;
length _EVENT16 8;
_catLabl=" ";
_trt=1;
_EVENT16=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT16=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT16=1;
_catord=1;
_cat=1;
output;
run;
proc sort data=_frame16;
by _datasrt _blcksrt _cat _EVENT16 _trt;
run;proc sort data=_pct16;
by _datasrt _blcksrt _cat _EVENT16 _trt;
run;data _pct16;
merge _frame16(in=_inframe) _pct16;
by _datasrt _blcksrt _cat _EVENT16 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct16;
by _datasrt _blcksrt _EVENT16;
run;data _miss16(keep=_datasrt _blcksrt _EVENT16 totcount);
set _pct16;
where _EVENT16=9998;
retain totcount;
by _datasrt _blcksrt _EVENT16;
if first._EVENT16 then
totcount=0;
totcount=totcount+count;
if last._EVENT16;
run;
FDA-CBER-2022-5812-0072195
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _pct16(drop=totcount);
merge _pct16 _miss16;
by _datasrt _blcksrt _EVENT16;
if totcount=0 then
delete;
run;
proc sort data=_denomf16;
by _datasrt _cat;
run;proc sort data=_denomin16;
by _datasrt _cat;
run;data _denomin16;
merge _denomf16(in=_inframe) _denomin16;
by _datasrt _cat;
if _inframe;
_blcksrt=5;
run;proc sort data=_pct16;
by _datasrt _cat;
run;data _pct16;
if 0 then
set _basetemplate;
merge _denomin16(in=_a) _pct16;
by _datasrt _cat;
if _a;
_varname="_EVENT16 ";
_vrlabel=" ";
_rwlabel="Received Dose 2/unplanned dose ";
if _EVENT16=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT16=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
FDA-CBER-2022-5812-0072196
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_pct16;
by _datasrt _blcksrt _catord _EVENT16 _trt _cat;
run;
data _base16;
length _catlabl $200;
set _pct16 end=eof;
by _datasrt _blcksrt _catord _EVENT16 _trt _cat;
retain _rowsrt 1 _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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT16 then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
FDA-CBER-2022-5812-0072197
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=4;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 17 */
data _anal17;
length _EVENT17 8;
set _data1;
where same and _EVENT17 is not missing;
_blcksrt=5;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal17;
by _datasrt _blcksrt _EVENT17 _trt _cat;
run;data _temp17;
set _anal17;
output;
run;proc sort data=_temp17 out=_temp917 nodupkey;
by _datasrt _blcksrt _cat _EVENT17 _trt usubjid;
;
run;proc freq data=_temp917;
format _EVENT17;
tables _datasrt*_blcksrt*_cat * _EVENT17 * _trt / sparse norow nocol nopercent
out=_pct17(drop=percent);
run;proc sort data=_anal17 out=_denom17(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;
FDA-CBER-2022-5812-0072198
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _denom17;
set _denom17;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;
data _denomf17;
_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=_denom17 out=_denomin17(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame17;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=5;
length _EVENT17 8;
_catLabl=" ";
_trt=1;
_EVENT17=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT17=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT17=1;
_catord=1;
_cat=1;
FDA-CBER-2022-5812-0072199
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] output;
run;
proc sort data=_frame17;
by _datasrt _blcksrt _cat _EVENT17 _trt;
run;proc sort data=_pct17;
by _datasrt _blcksrt _cat _EVENT17 _trt;
run;data _pct17;
merge _frame17(in=_inframe) _pct17;
by _datasrt _blcksrt _cat _EVENT17 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct17;
by _datasrt _blcksrt _EVENT17;
run;data _miss17(keep=_datasrt _blcksrt _EVENT17 totcount);
set _pct17;
where _EVENT17=9998;
retain totcount;
by _datasrt _blcksrt _EVENT17;
if first._EVENT17 then
totcount=0;
totcount=totcount+count;
if last._EVENT17;
run;data _pct17(drop=totcount);
merge _pct17 _miss17;
by _datasrt _blcksrt _EVENT17;
if totcount=0 then
delete;
run;proc sort data=_denomf17;
by _datasrt _cat;
run;proc sort data=_denomin17;
by _datasrt _cat;
run;
FDA-CBER-2022-5812-0072200
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _denomin17;
merge _denomf17(in=_inframe) _denomin17;
by _datasrt _cat;
if _inframe;
_blcksrt=5;
run;
proc sort data=_pct17;
by _datasrt _cat;
run;data _pct17;
if 0 then
set _basetemplate;
merge _denomin17(in=_a) _pct17;
by _datasrt _cat;
if _a;
_varname="_EVENT17 ";
_vrlabel=" ";
_rwlabel="Completed 1-month post(*ESC*){unicode 2013}Dose 2 visit ";
if _EVENT17=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT17=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct17;
by _datasrt _blcksrt _catord _EVENT17 _trt _cat;
run;data _base17;
length _catlabl $200;
set _pct17 end=eof;
by _datasrt _blcksrt _catord _EVENT17 _trt _cat;
retain _rowsrt 2 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
_cpct=' ';
_module='mcatstat';
if count > . then
FDA-CBER-2022-5812-0072201
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT17 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=4;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 18 */
FDA-CBER-2022-5812-0072202
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _anal18;
length _EVENT18 8;
set _data1;
where same and _EVENT18 is not missing;
_blcksrt=5;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal18;
by _datasrt _blcksrt _EVENT18 _trt _cat;
run;data _temp18;
set _anal18;
output;
run;proc sort data=_temp18 out=_temp918 nodupkey;
by _datasrt _blcksrt _cat _EVENT18 _trt usubjid;
;
run;proc freq data=_temp918;
format _EVENT18;
tables _datasrt*_blcksrt*_cat * _EVENT18 * _trt / sparse norow nocol nopercent
out=_pct18(drop=percent);
run;proc sort data=_anal18 out=_denom18(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom18;
set _denom18;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;
data _denomf18;
FDA-CBER-2022-5812-0072203
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _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=_denom18 out=_denomin18(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame18;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=5;
length _EVENT18 8;
_catLabl=" ";
_trt=1;
_EVENT18=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT18=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT18=1;
_catord=1;
_cat=1;
output;
run;proc sort data=_frame18;
by _datasrt _blcksrt _cat _EVENT18 _trt;
run;proc sort data=_pct18;
by _datasrt _blcksrt _cat _EVENT18 _trt;
run;data _pct18;
merge _frame18(in=_inframe) _pct18;
by _datasrt _blcksrt _cat _EVENT18 _trt;
if _inframe;
FDA-CBER-2022-5812-0072204
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if count=. then
count=0;
run;
proc sort data=_pct18;
by _datasrt _blcksrt _EVENT18;
run;data _miss18(keep=_datasrt _blcksrt _EVENT18 totcount);
set _pct18;
where _EVENT18=9998;
retain totcount;
by _datasrt _blcksrt _EVENT18;
if first._EVENT18 then
totcount=0;
totcount=totcount+count;
if last._EVENT18;
run;data _pct18(drop=totcount);
merge _pct18 _miss18;
by _datasrt _blcksrt _EVENT18;
if totcount=0 then
delete;
run;proc sort data=_denomf18;
by _datasrt _cat;
run;proc sort data=_denomin18;
by _datasrt _cat;
run;data _denomin18;
merge _denomf18(in=_inframe) _denomin18;
by _datasrt _cat;
if _inframe;
_blcksrt=5;
run;proc sort data=_pct18;
by _datasrt _cat;
run;data _pct18;
if 0 then
set _basetemplate;
merge _denomin18(in=_a) _pct18;
by _datasrt _cat;
FDA-CBER-2022-5812-0072205
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if _a;
_varname="_EVENT18 ";
_vrlabel=" ";
_rwlabel="Completed 6-month post(*ESC*){unicode 2013}Dose 2 visit ";
if _EVENT18=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT18=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct18;
by _datasrt _blcksrt _catord _EVENT18 _trt _cat;
run;data _base18;
length _catlabl $200;
set _pct18 end=eof;
by _datasrt _blcksrt _catord _EVENT18 _trt _cat;
retain _rowsrt 3 _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
FDA-CBER-2022-5812-0072206
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _cpct="(*ESC*){nbspace 1}(0.0)";
_cvalue=trim(_cvalue)||_cpct;
end;
end;
end;
/*
if length(_cvalue) < 13 then */
/*
do; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT18 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=4;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 19 */
data _anal19;
length _EVENT19 8;
set _data1;
where same and _EVENT19 is not missing;
_blcksrt=5;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal19;
by _datasrt _blcksrt _EVENT19 _trt _cat;
run;
FDA-CBER-2022-5812-0072207
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _temp19;
set _anal19;
output;
run;
proc sort data=_temp19 out=_temp919 nodupkey;
by _datasrt _blcksrt _cat _EVENT19 _trt usubjid;
;
run;proc freq data=_temp919;
format _EVENT19;
tables _datasrt*_blcksrt*_cat * _EVENT19 * _trt / sparse norow nocol nopercent
out=_pct19(drop=percent);
run;proc sort data=_anal19 out=_denom19(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom19;
set _denom19;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf19;
_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=_denom19 out=_denomin19(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;
FDA-CBER-2022-5812-0072208
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _frame19;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=5;
length _EVENT19 8;
_catLabl=" ";
_trt=1;
_EVENT19=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT19=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT19=1;
_catord=1;
_cat=1;
output;
run;
proc sort data=_frame19;
by _datasrt _blcksrt _cat _EVENT19 _trt;
run;proc sort data=_pct19;
by _datasrt _blcksrt _cat _EVENT19 _trt;
run;data _pct19;
merge _frame19(in=_inframe) _pct19;
by _datasrt _blcksrt _cat _EVENT19 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct19;
by _datasrt _blcksrt _EVENT19;
run;data _miss19(keep=_datasrt _blcksrt _EVENT19 totcount);
set _pct19;
where _EVENT19=9998;
retain totcount;
by _datasrt _blcksrt _EVENT19;
if first._EVENT19 then
totcount=0;
totcount=totcount+count;
FDA-CBER-2022-5812-0072209
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if last._EVENT19;
run;
data _pct19(drop=totcount);
merge _pct19 _miss19;
by _datasrt _blcksrt _EVENT19;
if totcount=0 then
delete;
run;proc sort data=_denomf19;
by _datasrt _cat;
run;proc sort data=_denomin19;
by _datasrt _cat;
run;data _denomin19;
merge _denomf19(in=_inframe) _denomin19;
by _datasrt _cat;
if _inframe;
_blcksrt=5;
run;proc sort data=_pct19;
by _datasrt _cat;
run;data _pct19;
if 0 then
set _basetemplate;
merge _denomin19(in=_a) _pct19;
by _datasrt _cat;
if _a;
_varname="_EVENT19 ";
_vrlabel=" ";
_rwlabel="Withdrawn from the study ";
if _EVENT19=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT19=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
FDA-CBER-2022-5812-0072210
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if _catord=. then
_catord=9997;
run;
proc sort data=_pct19;
by _datasrt _blcksrt _catord _EVENT19 _trt _cat;
run;data _base19;
length _catlabl $200;
set _pct19 end=eof;
by _datasrt _blcksrt _catord _EVENT19 _trt _cat;
retain _rowsrt 4 _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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT19 then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
FDA-CBER-2022-5812-0072211
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=4;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 20 */
data _anal20;
length _EVENT20 8;
set _data1;
where same and _EVENT20 is not missing;
_blcksrt=5;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal20;
by _datasrt _blcksrt _EVENT20 _trt _cat;
run;data _temp20;
set _anal20;
output;
run;proc sort data=_temp20 out=_temp920 nodupkey;
by _datasrt _blcksrt _cat _EVENT20 _trt usubjid;
;
run;proc freq data=_temp920;
format _EVENT20;
tables _datasrt*_blcksrt*_cat * _EVENT20 * _trt / sparse norow nocol nopercent
out=_pct20(drop=percent);
run;
proc sort data=_anal20 out=_denom20(keep=_datasrt _cat) nodupkey;
FDA-CBER-2022-5812-0072212
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] ;
by _datasrt _cat;
run;
data _denom20;
set _denom20;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf20;
_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=_denom20 out=_denomin20(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame20;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=5;
length _EVENT20 8;
_catLabl=" ";
_trt=1;
_EVENT20=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT20=1;
_catord=1;
_cat=1;
output;
_trt=3;
FDA-CBER-2022-5812-0072213
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _EVENT20=1;
_catord=1;
_cat=1;
output;
run;
proc sort data=_frame20;
by _datasrt _blcksrt _cat _EVENT20 _trt;
run;proc sort data=_pct20;
by _datasrt _blcksrt _cat _EVENT20 _trt;
run;data _pct20;
merge _frame20(in=_inframe) _pct20;
by _datasrt _blcksrt _cat _EVENT20 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct20;
by _datasrt _blcksrt _EVENT20;
run;data _miss20(keep=_datasrt _blcksrt _EVENT20 totcount);
set _pct20;
where _EVENT20=9998;
retain totcount;
by _datasrt _blcksrt _EVENT20;
if first._EVENT20 then
totcount=0;
totcount=totcount+count;
if last._EVENT20;
run;data _pct20(drop=totcount);
merge _pct20 _miss20;
by _datasrt _blcksrt _EVENT20;
if totcount=0 then
delete;
run;proc sort data=_denomf20;
by _datasrt _cat;
run;
proc sort data=_denomin20;
FDA-CBER-2022-5812-0072214
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] by _datasrt _cat;
run;
data _denomin20;
merge _denomf20(in=_inframe) _denomin20;
by _datasrt _cat;
if _inframe;
_blcksrt=5;
run;proc sort data=_pct20;
by _datasrt _cat;
run;data _pct20;
if 0 then
set _basetemplate;
merge _denomin20(in=_a) _pct20;
by _datasrt _cat;
if _a;
_varname="_EVENT20 ";
_vrlabel=" ";
_rwlabel="Withdrawn before 6-month post(*ESC*){unicode 2013}Dose 2 visit ";
if _EVENT20=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT20=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct20;
by _datasrt _blcksrt _catord _EVENT20 _trt _cat;
run;data _base20;
length _catlabl $200;
set _pct20 end=eof;
by _datasrt _blcksrt _catord _EVENT20 _trt _cat;
retain _rowsrt 5 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
_cpct=' ';
FDA-CBER-2022-5812-0072215
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT20 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;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
FDA-CBER-2022-5812-0072216
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]run;
/* Crit 21 */
data _anal21;
length _EVENT21 8;
set _data1;
where same and _EVENT21 is not missing;
_blcksrt=5;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal21;
by _datasrt _blcksrt _EVENT21 _trt _cat;
run;data _temp21;
set _anal21;
output;
run;proc sort data=_temp21 out=_temp921 nodupkey;
by _datasrt _blcksrt _cat _EVENT21 _trt usubjid;
;
run;proc freq data=_temp921;
format _EVENT21;
tables _datasrt*_blcksrt*_cat * _EVENT21 * _trt / sparse norow nocol nopercent
out=_pct21(drop=percent);
run;proc sort data=_anal21 out=_denom21(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom21;
set _denom21;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
FDA-CBER-2022-5812-0072217
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]run;
data _denomf21;
_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=_denom21 out=_denomin21(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame21;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=5;
length _EVENT21 8;
_catLabl=" ";
_trt=1;
_EVENT21=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT21=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT21=1;
_catord=1;
_cat=1;
output;
run;proc sort data=_frame21;
by _datasrt _blcksrt _cat _EVENT21 _trt;
run;proc sort data=_pct21;
by _datasrt _blcksrt _cat _EVENT21 _trt;
run;data _pct21;
merge _frame21(in=_inframe) _pct21;
by _datasrt _blcksrt _cat _EVENT21 _trt;
FDA-CBER-2022-5812-0072218
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if _inframe;
if count=. then
count=0;
run;
proc sort data=_pct21;
by _datasrt _blcksrt _EVENT21;
run;data _miss21(keep=_datasrt _blcksrt _EVENT21 totcount);
set _pct21;
where _EVENT21=9998;
retain totcount;
by _datasrt _blcksrt _EVENT21;
if first._EVENT21 then
totcount=0;
totcount=totcount+count;
if last._EVENT21;
run;data _pct21(drop=totcount);
merge _pct21 _miss21;
by _datasrt _blcksrt _EVENT21;
if totcount=0 then
delete;
run;proc sort data=_denomf21;
by _datasrt _cat;
run;proc sort data=_denomin21;
by _datasrt _cat;
run;data _denomin21;
merge _denomf21(in=_inframe) _denomin21;
by _datasrt _cat;
if _inframe;
_blcksrt=5;
run;proc sort data=_pct21;
by _datasrt _cat;
run;data _pct21;
if 0 then
FDA-CBER-2022-5812-0072219
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] set _basetemplate;
merge _denomin21(in=_a) _pct21;
by _datasrt _cat;
if _a;
_varname="_EVENT21 ";
_vrlabel=" ";
_rwlabel="Withdrawn after 6-month post(*ESC*){unicode 2013}Dose 2 visit ";
if _EVENT21=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT21=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct21;
by _datasrt _blcksrt _catord _EVENT21 _trt _cat;
run;data _base21;
length _catlabl $200;
set _pct21 end=eof;
by _datasrt _blcksrt _catord _EVENT21 _trt _cat;
retain _rowsrt 6 _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;
FDA-CBER-2022-5812-0072220
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] 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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT21 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;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 22 */
data _anal22;
length DSDECODN 8;
set _data1;
where same and DSDECODN is not missing;
_blcksrt=5;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal22;
FDA-CBER-2022-5812-0072221
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] by _datasrt _blcksrt DSDECODN _trt _cat;
run;
data _temp22;
set _anal22;
output;
run;proc sort data=_temp22 out=_temp922 nodupkey;
by _datasrt _blcksrt _cat DSDECODN _trt usubjid;
where RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2)
and (VAX101DT ne . or VAX102DT ne .) and (unblnddt ne . and
eosdcdt>=unblnddt) and index(arm, 'BNT');
run;proc freq data=_temp922;
format DSDECODN;
tables _datasrt*_blcksrt*_cat * DSDECODN * _trt / sparse norow nocol nopercent
out=_pct22(drop=percent);
run;proc sort data=_anal22 out=_denom22(keep=_datasrt _cat) nodupkey;
where RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2)
and (VAX101DT ne . or VAX102DT ne .) and (unblnddt ne . and
eosdcdt>=unblnddt) and index(arm, 'BNT');
by _datasrt _cat;
run;data _denom22;
set _denom22;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf22;
_datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
_trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;
FDA-CBER-2022-5812-0072222
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc transpose data=_denom22 out=_denomin22(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;
proc sort data=_pct22 out=_expv22 (keep=_datasrt _blcksrt DSDECODN) nodupkey;
by _datasrt _blcksrt DSDECODN;
run;proc sort data=_expv22;
by _datasrt _blcksrt DSDECODN;
run;data _frame22;
set _expv22;
by _datasrt _blcksrt DSDECODN;
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=_frame22;
by _datasrt _blcksrt _cat DSDECODN _trt;
run;proc sort data=_pct22;
by _datasrt _blcksrt _cat DSDECODN _trt;
run;data _pct22;
merge _frame22(in=_inframe) _pct22;
by _datasrt _blcksrt _cat DSDECODN _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct22;
by _datasrt _blcksrt DSDECODN;
run;
FDA-CBER-2022-5812-0072223
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _miss22(keep=_datasrt _blcksrt DSDECODN totcount);
set _pct22;
where DSDECODN=9998;
retain totcount;
by _datasrt _blcksrt DSDECODN;
if first.DSDECODN then
totcount=0;
totcount=totcount+count;
if last.DSDECODN;
run;
data _pct22(drop=totcount);
merge _pct22 _miss22;
by _datasrt _blcksrt DSDECODN;
if totcount=0 then
delete;
run;proc sort data=_denomf22;
by _datasrt _cat;
run;proc sort data=_denomin22;
by _datasrt _cat;
run;data _denomin22;
merge _denomf22(in=_inframe) _denomin22;
by _datasrt _cat;
if _inframe;
_blcksrt=5;
run;proc sort data=_pct22;
by _datasrt _cat;
run;data _pct22;
if 0 then
set _basetemplate;
merge _denomin22(in=_a) _pct22;
by _datasrt _cat;
if _a;
_varname="DSDECODN ";
_vrlabel="Reason for withdrawal from the study ";
_rwlabel=put(DSDECODN, dsdecod.);
if DSDECODN=9998 then
FDA-CBER-2022-5812-0072224
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] do;
_rwlabel="Missing ";
_catord=9998;
end;
else if DSDECODN=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct22;
by _datasrt _blcksrt _catord DSDECODN _trt _cat;
run;data _base22;
length _catlabl $200;
set _pct22 end=eof;
by _datasrt _blcksrt _catord DSDECODN _trt _cat;
retain _rowsrt 7 _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 */
FDA-CBER-2022-5812-0072225
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]/* do; */
*----------------------------------------------------------------------;
* Put character A0x at right most character to pad text;
*----------------------------------------------------------------------;
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first.DSDECODN 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=8;
_dptindt=4;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 23 */
data _anal23;
length _EVENT23 8;
set _data1;
where same and _EVENT23 is not missing;
_blcksrt=6;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal23;
by _datasrt _blcksrt _EVENT23 _trt _cat;
run;data _temp23;
set _anal23;
output;
run;
FDA-CBER-2022-5812-0072226
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_temp23 out=_temp923 nodupkey;
by _datasrt _blcksrt _cat _EVENT23 _trt usubjid;
;
run;
proc freq data=_temp923;
format _EVENT23;
tables _datasrt*_blcksrt*_cat * _EVENT23 * _trt / sparse norow nocol nopercent
out=_pct23(drop=percent);
run;proc sort data=_anal23 out=_denom23(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom23;
set _denom23;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf23;
_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=_denom23 out=_denomin23(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame23;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=6;
FDA-CBER-2022-5812-0072227
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] length _EVENT23 8;
_catLabl=" ";
_trt=1;
_EVENT23=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT23=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT23=1;
_catord=1;
_cat=1;
output;
run;
proc sort data=_frame23;
by _datasrt _blcksrt _cat _EVENT23 _trt;
run;proc sort data=_pct23;
by _datasrt _blcksrt _cat _EVENT23 _trt;
run;data _pct23;
merge _frame23(in=_inframe) _pct23;
by _datasrt _blcksrt _cat _EVENT23 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct23;
by _datasrt _blcksrt _EVENT23;
run;data _miss23(keep=_datasrt _blcksrt _EVENT23 totcount);
set _pct23;
where _EVENT23=9998;
retain totcount;
by _datasrt _blcksrt _EVENT23;
if first._EVENT23 then
totcount=0;
totcount=totcount+count;
if last._EVENT23;
run;
FDA-CBER-2022-5812-0072228
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _pct23(drop=totcount);
merge _pct23 _miss23;
by _datasrt _blcksrt _EVENT23;
if totcount=0 then
delete;
run;
proc sort data=_denomf23;
by _datasrt _cat;
run;proc sort data=_denomin23;
by _datasrt _cat;
run;data _denomin23;
merge _denomf23(in=_inframe) _denomin23;
by _datasrt _cat;
if _inframe;
_blcksrt=6;
run;proc sort data=_pct23;
by _datasrt _cat;
run;data _pct23;
if 0 then
set _basetemplate;
merge _denomin23(in=_a) _pct23;
by _datasrt _cat;
if _a;
_varname="_EVENT23 ";
_vrlabel=" ";
_rwlabel="Originally randomized to placebo ";
if _EVENT23=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT23=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
FDA-CBER-2022-5812-0072229
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_pct23;
by _datasrt _blcksrt _catord _EVENT23 _trt _cat;
run;
data _base23;
length _catlabl $200;
set _pct23 end=eof;
by _datasrt _blcksrt _catord _EVENT23 _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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT23 then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
FDA-CBER-2022-5812-0072230
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=2;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 24 */
data _anal24;
length _EVENT24 8;
set _data1;
where same and _EVENT24 is not missing;
_blcksrt=6;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal24;
by _datasrt _blcksrt _EVENT24 _trt _cat;
run;data _temp24;
set _anal24;
output;
run;proc sort data=_temp24 out=_temp924 nodupkey;
by _datasrt _blcksrt _cat _EVENT24 _trt usubjid;
;
run;proc freq data=_temp924;
format _EVENT24;
tables _datasrt*_blcksrt*_cat * _EVENT24 * _trt / sparse norow nocol nopercent
out=_pct24(drop=percent);
run;proc sort data=_anal24 out=_denom24(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;
FDA-CBER-2022-5812-0072231
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _denom24;
set _denom24;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;
data _denomf24;
_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=_denom24 out=_denomin24(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame24;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=6;
length _EVENT24 8;
_catLabl=" ";
_trt=1;
_EVENT24=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT24=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT24=1;
_catord=1;
_cat=1;
output;
FDA-CBER-2022-5812-0072232
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]run;
proc sort data=_frame24;
by _datasrt _blcksrt _cat _EVENT24 _trt;
run;
proc sort data=_pct24;
by _datasrt _blcksrt _cat _EVENT24 _trt;
run;data _pct24;
merge _frame24(in=_inframe) _pct24;
by _datasrt _blcksrt _cat _EVENT24 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct24;
by _datasrt _blcksrt _EVENT24;
run;data _miss24(keep=_datasrt _blcksrt _EVENT24 totcount);
set _pct24;
where _EVENT24=9998;
retain totcount;
by _datasrt _blcksrt _EVENT24;
if first._EVENT24 then
totcount=0;
totcount=totcount+count;
if last._EVENT24;
run;data _pct24(drop=totcount);
merge _pct24 _miss24;
by _datasrt _blcksrt _EVENT24;
if totcount=0 then
delete;
run;proc sort data=_denomf24;
by _datasrt _cat;
run;proc sort data=_denomin24;
by _datasrt _cat;
run;
data _denomin24;
FDA-CBER-2022-5812-0072233
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] merge _denomf24(in=_inframe) _denomin24;
by _datasrt _cat;
if _inframe;
_blcksrt=6;
run;
proc sort data=_pct24;
by _datasrt _cat;
run;data _pct24;
if 0 then
set _basetemplate;
merge _denomin24(in=_a) _pct24;
by _datasrt _cat;
if _a;
_varname="_EVENT24 ";
_vrlabel=" ";
_rwlabel="Withdrawn from the study after unblinding and before Dose 3 ";
if _EVENT24=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT24=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct24;
by _datasrt _blcksrt _catord _EVENT24 _trt _cat;
run;data _base24;
length _catlabl $200;
set _pct24 end=eof;
by _datasrt _blcksrt _catord _EVENT24 _trt _cat;
retain _rowsrt 1 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
_cpct=' ';
_module='mcatstat';
if count > . then
_cvalue=put(count, 5.);
FDA-CBER-2022-5812-0072234
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] 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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT24 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=4;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 25 */
data _anal25;
FDA-CBER-2022-5812-0072235
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] length _EVENT25 8;
set _data1;
where same and _EVENT25 is not missing;
_blcksrt=6;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal25;
by _datasrt _blcksrt _EVENT25 _trt _cat;
run;data _temp25;
set _anal25;
output;
run;proc sort data=_temp25 out=_temp925 nodupkey;
by _datasrt _blcksrt _cat _EVENT25 _trt usubjid;
;
run;proc freq data=_temp925;
format _EVENT25;
tables _datasrt*_blcksrt*_cat * _EVENT25 * _trt / sparse norow nocol nopercent
out=_pct25(drop=percent);
run;proc sort data=_anal25 out=_denom25(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom25;
set _denom25;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf25;
_datasrt=1;
FDA-CBER-2022-5812-0072236
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
_trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
_cat=1;
output;
run;
proc transpose data=_denom25 out=_denomin25(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame25;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=6;
length _EVENT25 8;
_catLabl=" ";
_trt=1;
_EVENT25=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT25=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT25=1;
_catord=1;
_cat=1;
output;
run;proc sort data=_frame25;
by _datasrt _blcksrt _cat _EVENT25 _trt;
run;proc sort data=_pct25;
by _datasrt _blcksrt _cat _EVENT25 _trt;
run;data _pct25;
merge _frame25(in=_inframe) _pct25;
by _datasrt _blcksrt _cat _EVENT25 _trt;
if _inframe;
if count=. then
FDA-CBER-2022-5812-0072237
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] count=0;
run;
proc sort data=_pct25;
by _datasrt _blcksrt _EVENT25;
run;data _miss25(keep=_datasrt _blcksrt _EVENT25 totcount);
set _pct25;
where _EVENT25=9998;
retain totcount;
by _datasrt _blcksrt _EVENT25;
if first._EVENT25 then
totcount=0;
totcount=totcount+count;
if last._EVENT25;
run;data _pct25(drop=totcount);
merge _pct25 _miss25;
by _datasrt _blcksrt _EVENT25;
if totcount=0 then
delete;
run;proc sort data=_denomf25;
by _datasrt _cat;
run;proc sort data=_denomin25;
by _datasrt _cat;
run;data _denomin25;
merge _denomf25(in=_inframe) _denomin25;
by _datasrt _cat;
if _inframe;
_blcksrt=6;
run;proc sort data=_pct25;
by _datasrt _cat;
run;data _pct25;
if 0 then
set _basetemplate;
merge _denomin25(in=_a) _pct25;
by _datasrt _cat;
FDA-CBER-2022-5812-0072238
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if _a;
_varname="_EVENT25 ";
_vrlabel=" ";
_rwlabel="Received Dose 3 (first dose of BNT162b2 [30 (*ESC*){unicode 03BC}g]) ";
if _EVENT25=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT25=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct25;
by _datasrt _blcksrt _catord _EVENT25 _trt _cat;
run;data _base25;
length _catlabl $200;
set _pct25 end=eof;
by _datasrt _blcksrt _catord _EVENT25 _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.);
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)";
FDA-CBER-2022-5812-0072239
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _cvalue=trim(_cvalue)||_cpct;
end;
end;
end;
/*
if length(_cvalue) < 13 then */
/*
do; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT25 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=4;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 26 */
data _anal26;
length _EVENT26 8;
set _data1;
where same and _EVENT26 is not missing;
_blcksrt=6;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal26;
by _datasrt _blcksrt _EVENT26 _trt _cat;
run;
data _temp26;
FDA-CBER-2022-5812-0072240
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] set _anal26;
output;
run;
proc sort data=_temp26 out=_temp926 nodupkey;
by _datasrt _blcksrt _cat _EVENT26 _trt usubjid;
;
run;proc freq data=_temp926;
format _EVENT26;
tables _datasrt*_blcksrt*_cat * _EVENT26 * _trt / sparse norow nocol nopercent
out=_pct26(drop=percent);
run;proc sort data=_anal26 out=_denom26(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom26;
set _denom26;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf26;
_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=_denom26 out=_denomin26(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;
data _frame26;
FDA-CBER-2022-5812-0072241
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _datasrt=1;
set _bydat1(keep=);
_blcksrt=6;
length _EVENT26 8;
_catLabl=" ";
_trt=1;
_EVENT26=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT26=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT26=1;
_catord=1;
_cat=1;
output;
run;
proc sort data=_frame26;
by _datasrt _blcksrt _cat _EVENT26 _trt;
run;proc sort data=_pct26;
by _datasrt _blcksrt _cat _EVENT26 _trt;
run;data _pct26;
merge _frame26(in=_inframe) _pct26;
by _datasrt _blcksrt _cat _EVENT26 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct26;
by _datasrt _blcksrt _EVENT26;
run;data _miss26(keep=_datasrt _blcksrt _EVENT26 totcount);
set _pct26;
where _EVENT26=9998;
retain totcount;
by _datasrt _blcksrt _EVENT26;
if first._EVENT26 then
totcount=0;
totcount=totcount+count;
FDA-CBER-2022-5812-0072242
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if last._EVENT26;
run;
data _pct26(drop=totcount);
merge _pct26 _miss26;
by _datasrt _blcksrt _EVENT26;
if totcount=0 then
delete;
run;proc sort data=_denomf26;
by _datasrt _cat;
run;proc sort data=_denomin26;
by _datasrt _cat;
run;data _denomin26;
merge _denomf26(in=_inframe) _denomin26;
by _datasrt _cat;
if _inframe;
_blcksrt=6;
run;proc sort data=_pct26;
by _datasrt _cat;
run;data _pct26;
if 0 then
set _basetemplate;
merge _denomin26(in=_a) _pct26;
by _datasrt _cat;
if _a;
_varname="_EVENT26 ";
_vrlabel=" ";
_rwlabel="Received Dose 4 (second dose of BNT162b2 [30 (*ESC*){unicode 03BC}g]) ";
if _EVENT26=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT26=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
FDA-CBER-2022-5812-0072243
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _catord=9997;
run;
proc sort data=_pct26;
by _datasrt _blcksrt _catord _EVENT26 _trt _cat;
run;data _base26;
length _catlabl $200;
set _pct26 end=eof;
by _datasrt _blcksrt _catord _EVENT26 _trt _cat;
retain _rowsrt 3 _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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT26 then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
FDA-CBER-2022-5812-0072244
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _dptindt=0;
_vorder=1;
_rowjump=1;
if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=4;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 27 */
data _anal27;
length _EVENT27 8;
set _data1;
where same and _EVENT27 is not missing;
_blcksrt=7;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal27;
by _datasrt _blcksrt _EVENT27 _trt _cat;
run;data _temp27;
set _anal27;
output;
run;proc sort data=_temp27 out=_temp927 nodupkey;
by _datasrt _blcksrt _cat _EVENT27 _trt usubjid;
;
run;proc freq data=_temp927;
format _EVENT27;
tables _datasrt*_blcksrt*_cat * _EVENT27 * _trt / sparse norow nocol nopercent
out=_pct27(drop=percent);
run;proc sort data=_anal27 out=_denom27(keep=_datasrt _cat) nodupkey;
;
FDA-CBER-2022-5812-0072245
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] by _datasrt _cat;
run;
data _denom27;
set _denom27;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf27;
_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=_denom27 out=_denomin27(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame27;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=7;
length _EVENT27 8;
_catLabl=" ";
_trt=1;
_EVENT27=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT27=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT27=1;
FDA-CBER-2022-5812-0072246
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _catord=1;
_cat=1;
output;
run;
proc sort data=_frame27;
by _datasrt _blcksrt _cat _EVENT27 _trt;
run;proc sort data=_pct27;
by _datasrt _blcksrt _cat _EVENT27 _trt;
run;data _pct27;
merge _frame27(in=_inframe) _pct27;
by _datasrt _blcksrt _cat _EVENT27 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct27;
by _datasrt _blcksrt _EVENT27;
run;data _miss27(keep=_datasrt _blcksrt _EVENT27 totcount);
set _pct27;
where _EVENT27=9998;
retain totcount;
by _datasrt _blcksrt _EVENT27;
if first._EVENT27 then
totcount=0;
totcount=totcount+count;
if last._EVENT27;
run;data _pct27(drop=totcount);
merge _pct27 _miss27;
by _datasrt _blcksrt _EVENT27;
if totcount=0 then
delete;
run;proc sort data=_denomf27;
by _datasrt _cat;
run;proc sort data=_denomin27;
by _datasrt _cat;
FDA-CBER-2022-5812-0072247
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]run;
data _denomin27;
merge _denomf27(in=_inframe) _denomin27;
by _datasrt _cat;
if _inframe;
_blcksrt=7;
run;
proc sort data=_pct27;
by _datasrt _cat;
run;data _pct27;
if 0 then
set _basetemplate;
merge _denomin27(in=_a) _pct27;
by _datasrt _cat;
if _a;
_varname="_EVENT27 ";
_vrlabel=" ";
_rwlabel="Discontinued from open-label vaccination period~{super d} ";
if _EVENT27=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT27=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct27;
by _datasrt _blcksrt _catord _EVENT27 _trt _cat;
run;data _base27;
length _catlabl $200;
set _pct27 end=eof;
by _datasrt _blcksrt _catord _EVENT27 _trt _cat;
retain _rowsrt 0 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
drop _rowmax _cpct;
length _cpct $100;
_cpct=' ';
_module='mcatstat';
FDA-CBER-2022-5812-0072248
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] 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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT27 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=4;
_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-2022-5812-0072249
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]/* Crit 28 */
data _anal28;
length DSDECODN 8;
set _data1;
where same and DSDECODN is not missing;
_blcksrt=7;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal28;
by _datasrt _blcksrt DSDECODN _trt _cat;
run;data _temp28;
set _anal28;
output;
run;proc sort data=_temp28 out=_temp928 nodupkey;
by _datasrt _blcksrt _cat DSDECODN _trt usubjid;
where RANDFL eq 'Y' and DSPHASEN=7 and EOTXDCDT ne . and dsdecodn not in (. 2)
and vax201dt ne . and index(armcd, 'PLACEBO');
run;proc freq data=_temp928;
format DSDECODN;
tables _datasrt*_blcksrt*_cat * DSDECODN * _trt / sparse norow nocol nopercent
out=_pct28(drop=percent);
run;proc sort data=_anal28 out=_denom28(keep=_datasrt _cat) nodupkey;
where RANDFL eq 'Y' and DSPHASEN=7 and EOTXDCDT ne . and dsdecodn not in (. 2)
and vax201dt ne . and index(armcd, 'PLACEBO');
by _datasrt _cat;
run;data _denom28;
set _denom28;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
FDA-CBER-2022-5812-0072250
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] output;
run;
data _denomf28;
_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=_denom28 out=_denomin28(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;proc sort data=_pct28 out=_expv28 (keep=_datasrt _blcksrt DSDECODN) nodupkey;
by _datasrt _blcksrt DSDECODN;
run;proc sort data=_expv28;
by _datasrt _blcksrt DSDECODN;
run;data _frame28;
set _expv28;
by _datasrt _blcksrt DSDECODN;
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=_frame28;
by _datasrt _blcksrt _cat DSDECODN _trt;
run;proc sort data=_pct28;
by _datasrt _blcksrt _cat DSDECODN _trt;
run;
FDA-CBER-2022-5812-0072251
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _pct28;
merge _frame28(in=_inframe) _pct28;
by _datasrt _blcksrt _cat DSDECODN _trt;
if _inframe;
if count=. then
count=0;
run;
proc sort data=_pct28;
by _datasrt _blcksrt DSDECODN;
run;data _miss28(keep=_datasrt _blcksrt DSDECODN totcount);
set _pct28;
where DSDECODN=9998;
retain totcount;
by _datasrt _blcksrt DSDECODN;
if first.DSDECODN then
totcount=0;
totcount=totcount+count;
if last.DSDECODN;
run;data _pct28(drop=totcount);
merge _pct28 _miss28;
by _datasrt _blcksrt DSDECODN;
if totcount=0 then
delete;
run;proc sort data=_denomf28;
by _datasrt _cat;
run;proc sort data=_denomin28;
by _datasrt _cat;
run;data _denomin28;
merge _denomf28(in=_inframe) _denomin28;
by _datasrt _cat;
if _inframe;
_blcksrt=7;
run;proc sort data=_pct28;
by _datasrt _cat;
FDA-CBER-2022-5812-0072252
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]run;
data _pct28;
if 0 then
set _basetemplate;
merge _denomin28(in=_a) _pct28;
by _datasrt _cat;
if _a;
_varname="DSDECODN ";
_vrlabel="Reason for discontinuation from open-label vaccination period ";
_rwlabel=put(DSDECODN, dsdecod.);
if DSDECODN=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if DSDECODN=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
proc sort data=_pct28;
by _datasrt _blcksrt _catord DSDECODN _trt _cat;
run;data _base28;
length _catlabl $200;
set _pct28 end=eof;
by _datasrt _blcksrt _catord DSDECODN _trt _cat;
retain _rowsrt 1 _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;
FDA-CBER-2022-5812-0072253
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 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.DSDECODN 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=8;
_dptindt=4;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 29 */
data _anal29;
length _EVENT29 8;
set _data1;
where same and _EVENT29 is not missing;
_blcksrt=8;
_cnt=1;
_cat=1;
FDA-CBER-2022-5812-0072254
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if _trt <=0 then
delete;
output;
run;
proc sort data=_anal29;
by _datasrt _blcksrt _EVENT29 _trt _cat;
run;data _temp29;
set _anal29;
output;
run;proc sort data=_temp29 out=_temp929 nodupkey;
by _datasrt _blcksrt _cat _EVENT29 _trt usubjid;
;
run;proc freq data=_temp929;
format _EVENT29;
tables _datasrt*_blcksrt*_cat * _EVENT29 * _trt / sparse norow nocol nopercent
out=_pct29(drop=percent);
run;proc sort data=_anal29 out=_denom29(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom29;
set _denom29;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf29;
_datasrt=1;
set _bydat1(keep=);
* All treatment groups ;
_trt1=0;
_trt2=0;
_trt3=0;
* _CAT is the subgroup variable ;
FDA-CBER-2022-5812-0072255
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _cat=1;
output;
run;
proc transpose data=_denom29 out=_denomin29(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame29;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=8;
length _EVENT29 8;
_catLabl=" ";
_trt=1;
_EVENT29=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT29=1;
_catord=1;
_cat=1; output; _trt=3; _EVENT29=1; _catord=1; _cat=1; output;run;
proc sort data=_frame29;
by _datasrt _blcksrt _cat _EVENT29 _trt;run;
proc sort data=_pct29;
by _datasrt _blcksrt _cat _EVENT29 _trt;run;
data _pct29;
merge _frame29(in=_inframe) _pct29; by _datasrt _blcksrt _cat _EVENT29 _trt;
if _inframe; if count=. then
count=0;run;
proc sort data=_pct29;
by _datasrt _blcksrt _EVENT29;
run;
FDA-CBER-2022-5812-0072256
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _miss29(keep=_datasrt _blcksrt _EVENT29 totcount);
set _pct29; where _EVENT29=9998; retain totcount; by _datasrt _blcksrt _EVENT29;
if first._EVENT29 then
totcount=0; totcount=totcount+count;
if last._EVENT29;
run;
data _pct29(drop=totcount);
merge _pct29 _miss29; by _datasrt _blcksrt _EVENT29;
if totcount=0 then
delete;run;
proc sort data=_denomf29;
by _datasrt _cat;run;
proc sort data=_denomin29;
by _datasrt _cat;run;
data _denomin29;
merge _denomf29(in=_inframe) _denomin29; by _datasrt _cat;
if _inframe;
_blcksrt=8;run;
proc sort data=_pct29;
by _datasrt _cat;run;
data _pct29;
if 0 then set _basetemplate; merge _denomin29(in=_a) _pct29; by _datasrt _cat;
if _a;
_varname="_EVENT29 "; _vrlabel=" "; _rwlabel="Completed 1-month post(*ESC*){unicode 2013}Dose 4 visit ";
if _EVENT29=9998 then
FDA-CBER-2022-5812-0072257
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] do;
_rwlabel="Missing ";
_catord=9998; end; else if _EVENT29=9999 then do; _rwlabel="Total "; _catord=9999; end;
if _catord=. then
_catord=9997;run;
proc sort data=_pct29;
by _datasrt _blcksrt _catord _EVENT29 _trt _cat;run;
data _base29;
length _catlabl $200; set _pct29 end=eof; by _datasrt _blcksrt _catord _EVENT29 _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 */
FDA-CBER-2022-5812-0072258
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]/* do; */
/* substr(_cvalue, 13, 1)='A0'x; */
/* end; */
if first._EVENT29 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=4; _dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.))); _direct="TOP "; _p=2;run;
/* Crit 30 */
data _anal30; length _EVENT30 8; set _data1; where same and _EVENT30 is not missing; _blcksrt=9; _cnt=1; _cat=1;
if _trt <=0 then
delete; output;run;
proc sort data=_anal30;
by _datasrt _blcksrt _EVENT30 _trt _cat;run;
data _temp30;
set _anal30; output;run;
proc sort data=_temp30 out=_temp930 nodupkey;
by _datasrt _blcksrt _cat _EVENT30 _trt usubjid;
FDA-CBER-2022-5812-0072259
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] ;
run;
proc freq data=_temp930;
format _EVENT30; tables _datasrt*_blcksrt*_cat * _EVENT30 * _trt / sparse norow nocol nopercent out=_pct30(drop=percent);run;
proc sort data=_anal30 out=_denom30(keep=_datasrt _cat) nodupkey;
; by _datasrt _cat;run;
data _denom30;
set _denom30; by _datasrt _cat; label count='count'; _trt=1; count=&_trt1.; output; _trt=2; count=&_trt2.; output; _trt=3; count=&_trt3.; output;run;
data _denomf30;
_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=_denom30 out=_denomin30(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat; var count; id _trt;run;
data _frame30;
_datasrt=1; set _bydat1(keep=); _blcksrt=9; length _EVENT30 8; _catLabl=" ";
_trt=1;
FDA-CBER-2022-5812-0072260
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _EVENT30=1;
_catord=1;
_cat=1; output; _trt=2; _EVENT30=1; _catord=1; _cat=1; output; _trt=3; _EVENT30=1; _catord=1; _cat=1; output;run;
proc sort data=_frame30;
by _datasrt _blcksrt _cat _EVENT30 _trt;run;
proc sort data=_pct30;
by _datasrt _blcksrt _cat _EVENT30 _trt;run;
data _pct30;
merge _frame30(in=_inframe) _pct30; by _datasrt _blcksrt _cat _EVENT30 _trt;
if _inframe; if count=. then
count=0;run;
proc sort data=_pct30;
by _datasrt _blcksrt _EVENT30;run;
data _miss30(keep=_datasrt _blcksrt _EVENT30 totcount);
set _pct30; where _EVENT30=9998; retain totcount; by _datasrt _blcksrt _EVENT30;
if first._EVENT30 then
totcount=0; totcount=totcount+count;
if last._EVENT30;
run;
data _pct30(drop=totcount);
merge _pct30 _miss30;
by _datasrt _blcksrt _EVENT30;
FDA-CBER-2022-5812-0072261
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if totcount=0 then
delete;run;
proc sort data=_denomf30;
by _datasrt _cat;run;
proc sort data=_denomin30;
by _datasrt _cat;run;
data _denomin30;
merge _denomf30(in=_inframe) _denomin30; by _datasrt _cat;
if _inframe;
_blcksrt=9;run;
proc sort data=_pct30;
by _datasrt _cat;run;
data _pct30;
if 0 then set _basetemplate; merge _denomin30(in=_a) _pct30; by _datasrt _cat;
if _a;
_varname="_EVENT30 "; _vrlabel=" "; _rwlabel="Withdrawn from the study ";
if _EVENT30=9998 then
do; _rwlabel="Missing "; _catord=9998; end; else if _EVENT30=9999 then do; _rwlabel="Total "; _catord=9999; end;
if _catord=. then
_catord=9997;run;
proc sort data=_pct30;
by _datasrt _blcksrt _catord _EVENT30 _trt _cat;run;
FDA-CBER-2022-5812-0072262
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _base30;
length _catlabl $200; set _pct30 end=eof; by _datasrt _blcksrt _catord _EVENT30 _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; *//* substr(_cvalue, 13, 1)='A0'x; *//* end; */
if first._EVENT30 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-2022-5812-0072263
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _indent=4;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.))); _direct="TOP "; _p=2;run;
/* Crit 31 */
data _anal31; length _EVENT31 8; set _data1; where same and _EVENT31 is not missing; _blcksrt=9; _cnt=1; _cat=1;
if _trt <=0 then
delete; output;run;
proc sort data=_anal31;
by _datasrt _blcksrt _EVENT31 _trt _cat;run;
data _temp31;
set _anal31; output;run;
proc sort data=_temp31 out=_temp931 nodupkey;
by _datasrt _blcksrt _cat _EVENT31 _trt usubjid; ;run;
proc freq data=_temp931;
format _EVENT31; tables _datasrt*_blcksrt*_cat * _EVENT31 * _trt / sparse norow nocol nopercent out=_pct31(drop=percent);run;
proc sort data=_anal31 out=_denom31(keep=_datasrt _cat) nodupkey;
; by _datasrt _cat;run;
data _denom31;
set _denom31;
by _datasrt _cat;
FDA-CBER-2022-5812-0072264
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] label count='count';
_trt=1;
count=&_trt1.; output; _trt=2; count=&_trt2.; output; _trt=3; count=&_trt3.; output;run;
data _denomf31;
_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=_denom31 out=_denomin31(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat; var count; id _trt;run;
data _frame31;
_datasrt=1; set _bydat1(keep=); _blcksrt=9; length _EVENT31 8; _catLabl=" "; _trt=1; _EVENT31=1; _catord=1; _cat=1; output; _trt=2; _EVENT31=1; _catord=1; _cat=1; output; _trt=3; _EVENT31=1; _catord=1; _cat=1; output;run;
proc sort data=_frame31;
FDA-CBER-2022-5812-0072265
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] by _datasrt _blcksrt _cat _EVENT31 _trt;
run;
proc sort data=_pct31;
by _datasrt _blcksrt _cat _EVENT31 _trt;run;
data _pct31;
merge _frame31(in=_inframe) _pct31; by _datasrt _blcksrt _cat _EVENT31 _trt;
if _inframe; if count=. then
count=0;run;
proc sort data=_pct31;
by _datasrt _blcksrt _EVENT31;run;
data _miss31(keep=_datasrt _blcksrt _EVENT31 totcount);
set _pct31; where _EVENT31=9998; retain totcount; by _datasrt _blcksrt _EVENT31;
if first._EVENT31 then
totcount=0; totcount=totcount+count;
if last._EVENT31;
run;
data _pct31(drop=totcount);
merge _pct31 _miss31; by _datasrt _blcksrt _EVENT31;
if totcount=0 then
delete;run;
proc sort data=_denomf31;
by _datasrt _cat;run;
proc sort data=_denomin31;
by _datasrt _cat;run;
data _denomin31;
merge _denomf31(in=_inframe) _denomin31; by _datasrt _cat;
FDA-CBER-2022-5812-0072266
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if _inframe;
_blcksrt=9;
run;
proc sort data=_pct31;
by _datasrt _cat;run;
data _pct31;
if 0 then set _basetemplate; merge _denomin31(in=_a) _pct31; by _datasrt _cat;
if _a;
_varname="_EVENT31 "; _vrlabel=" "; _rwlabel="Withdrawn after Dose 3 and before Dose 4 ";
if _EVENT31=9998 then
do; _rwlabel="Missing "; _catord=9998; end; else if _EVENT31=9999 then do; _rwlabel="Total "; _catord=9999; end;
if _catord=. then
_catord=9997;run;
proc sort data=_pct31;
by _datasrt _blcksrt _catord _EVENT31 _trt _cat;run;
data _base31;
length _catlabl $200; set _pct31 end=eof; by _datasrt _blcksrt _catord _EVENT31 _trt _cat; retain _rowsrt 1 _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-2022-5812-0072267
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 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; *//* substr(_cvalue, 13, 1)='A0'x; *//* end; */
if first._EVENT31 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;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.))); _direct="TOP "; _p=2;run;
/* Crit 32 */
data _anal32; length _EVENT32 8; set _data1;
where same and _EVENT32 is not missing;
FDA-CBER-2022-5812-0072268
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _blcksrt=9;
_cnt=1;
_cat=1;
if _trt <=0 then
delete; output;run;
proc sort data=_anal32;
by _datasrt _blcksrt _EVENT32 _trt _cat;run;
data _temp32;
set _anal32; output;run;
proc sort data=_temp32 out=_temp932 nodupkey;
by _datasrt _blcksrt _cat _EVENT32 _trt usubjid; ;run;
proc freq data=_temp932;
format _EVENT32; tables _datasrt*_blcksrt*_cat * _EVENT32 * _trt / sparse norow nocol nopercent out=_pct32(drop=percent);run;
proc sort data=_anal32 out=_denom32(keep=_datasrt _cat) nodupkey;
; by _datasrt _cat;run;
data _denom32;
set _denom32; by _datasrt _cat; label count='count'; _trt=1; count=&_trt1.; output; _trt=2; count=&_trt2.; output; _trt=3; count=&_trt3.; output;run;
data _denomf32;
_datasrt=1; set _bydat1(keep=); * All treatment groups ;
_trt1=0;
FDA-CBER-2022-5812-0072269
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _trt2=0;
_trt3=0;
* _CAT is the subgroup variable ; _cat=1; output;run;
proc transpose data=_denom32 out=_denomin32(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat; var count; id _trt;run;
data _frame32;
_datasrt=1; set _bydat1(keep=); _blcksrt=9; length _EVENT32 8; _catLabl=" "; _trt=1; _EVENT32=1; _catord=1; _cat=1; output; _trt=2; _EVENT32=1; _catord=1; _cat=1; output; _trt=3; _EVENT32=1; _catord=1; _cat=1; output;run;
proc sort data=_frame32;
by _datasrt _blcksrt _cat _EVENT32 _trt;run;
proc sort data=_pct32;
by _datasrt _blcksrt _cat _EVENT32 _trt;run;
data _pct32;
merge _frame32(in=_inframe) _pct32; by _datasrt _blcksrt _cat _EVENT32 _trt;
if _inframe; if count=. then
count=0;run;
FDA-CBER-2022-5812-0072270
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_pct32;
by _datasrt _blcksrt _EVENT32;
run;
data _miss32(keep=_datasrt _blcksrt _EVENT32 totcount);
set _pct32; where _EVENT32=9998; retain totcount; by _datasrt _blcksrt _EVENT32;
if first._EVENT32 then
totcount=0; totcount=totcount+count;
if last._EVENT32;
run;
data _pct32(drop=totcount);
merge _pct32 _miss32; by _datasrt _blcksrt _EVENT32;
if totcount=0 then
delete;run;
proc sort data=_denomf32;
by _datasrt _cat;run;
proc sort data=_denomin32;
by _datasrt _cat;run;
data _denomin32;
merge _denomf32(in=_inframe) _denomin32; by _datasrt _cat;
if _inframe;
_blcksrt=9;run;
proc sort data=_pct32;
by _datasrt _cat;run;
data _pct32;
if 0 then set _basetemplate; merge _denomin32(in=_a) _pct32; by _datasrt _cat;
if _a;
_varname="_EVENT32 ";
_vrlabel=" ";
FDA-CBER-2022-5812-0072271
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _rwlabel="Withdrawn after Dose 4 and before 1-month post(*ESC*){unicode 2013}Dose 4 visit ";
if _EVENT32=9998 then
do; _rwlabel="Missing "; _catord=9998; end; else if _EVENT32=9999 then do; _rwlabel="Total "; _catord=9999; end;
if _catord=. then
_catord=9997;run;
proc sort data=_pct32;
by _datasrt _blcksrt _catord _EVENT32 _trt _cat;run;
data _base32;
length _catlabl $200; set _pct32 end=eof; by _datasrt _blcksrt _catord _EVENT32 _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.);
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;
FDA-CBER-2022-5812-0072272
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] end;
/* if length(_cvalue) < 13 then */
/*
do; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT32 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;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 33 */
data _anal33;
length _EVENT33 8;
set _data1;
where same and _EVENT33 is not missing;
_blcksrt=9;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal33;
by _datasrt _blcksrt _EVENT33 _trt _cat;
run;data _temp33;
set _anal33;
output;
run;
FDA-CBER-2022-5812-0072273
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_temp33 out=_temp933 nodupkey;
by _datasrt _blcksrt _cat _EVENT33 _trt usubjid;
;
run;
proc freq data=_temp933;
format _EVENT33;
tables _datasrt*_blcksrt*_cat * _EVENT33 * _trt / sparse norow nocol nopercent
out=_pct33(drop=percent);
run;proc sort data=_anal33 out=_denom33(keep=_datasrt _cat) nodupkey;
;
by _datasrt _cat;
run;data _denom33;
set _denom33;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf33;
_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=_denom33 out=_denomin33(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;data _frame33;
_datasrt=1;
set _bydat1(keep=);
_blcksrt=9;
FDA-CBER-2022-5812-0072274
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] length _EVENT33 8;
_catLabl=" ";
_trt=1;
_EVENT33=1;
_catord=1;
_cat=1;
output;
_trt=2;
_EVENT33=1;
_catord=1;
_cat=1;
output;
_trt=3;
_EVENT33=1;
_catord=1;
_cat=1;
output;
run;
proc sort data=_frame33;
by _datasrt _blcksrt _cat _EVENT33 _trt;
run;proc sort data=_pct33;
by _datasrt _blcksrt _cat _EVENT33 _trt;
run;data _pct33;
merge _frame33(in=_inframe) _pct33;
by _datasrt _blcksrt _cat _EVENT33 _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct33;
by _datasrt _blcksrt _EVENT33;
run;data _miss33(keep=_datasrt _blcksrt _EVENT33 totcount);
set _pct33;
where _EVENT33=9998;
retain totcount;
by _datasrt _blcksrt _EVENT33;
if first._EVENT33 then
totcount=0;
totcount=totcount+count;
if last._EVENT33;
run;
FDA-CBER-2022-5812-0072275
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]data _pct33(drop=totcount);
merge _pct33 _miss33;
by _datasrt _blcksrt _EVENT33;
if totcount=0 then
delete;
run;
proc sort data=_denomf33;
by _datasrt _cat;
run;proc sort data=_denomin33;
by _datasrt _cat;
run;data _denomin33;
merge _denomf33(in=_inframe) _denomin33;
by _datasrt _cat;
if _inframe;
_blcksrt=9;
run;proc sort data=_pct33;
by _datasrt _cat;
run;data _pct33;
if 0 then
set _basetemplate;
merge _denomin33(in=_a) _pct33;
by _datasrt _cat;
if _a;
_varname="_EVENT33 ";
_vrlabel=" ";
_rwlabel="Withdrawn after 1-month post(*ESC*){unicode 2013}Dose 4 visit ";
if _EVENT33=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if _EVENT33=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;
FDA-CBER-2022-5812-0072276
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort data=_pct33;
by _datasrt _blcksrt _catord _EVENT33 _trt _cat;
run;
data _base33;
length _catlabl $200;
set _pct33 end=eof;
by _datasrt _blcksrt _catord _EVENT33 _trt _cat;
retain _rowsrt 3 _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; */
/*
substr(_cvalue, 13, 1)='A0'x; */
/*
end; */
if first._EVENT33 then
do;
_rowsrt=_rowsrt + 1;
_rowmax=max(_rowsrt, _rowmax);
end;
_datatyp='data';
_indent=0;
_dptindt=0;
_vorder=1;
_rowjump=1;
FDA-CBER-2022-5812-0072277
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if upcase(_rwlabel)='_NONE_' then
_rwlabel=' ';
_indent=6;
_dptindt=0;
if _trt=3 +1 then
_trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Crit 34 */
data _anal34;
length DSDECODN 8;
set _data1;
where same and DSDECODN is not missing;
_blcksrt=9;
_cnt=1;
_cat=1;
if _trt <=0 then
delete;
output;
run;
proc sort data=_anal34;
by _datasrt _blcksrt DSDECODN _trt _cat;
run;data _temp34;
set _anal34;
output;
run;proc sort data=_temp34 out=_temp934 nodupkey;
by _datasrt _blcksrt _cat DSDECODN _trt usubjid;
where RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2)
and (VAX201DT ne . or VAX202DT ne .) and ((unblnddt ne . and
eosdcdt>=unblnddt) or eosdcdt=eotxdcdt) and index(armcd, 'PLACEBO');
run;proc freq data=_temp934;
format DSDECODN;
tables _datasrt*_blcksrt*_cat * DSDECODN * _trt / sparse norow nocol nopercent
out=_pct34(drop=percent);
run;proc sort data=_anal34 out=_denom34(keep=_datasrt _cat) nodupkey;
where RANDFL eq 'Y' and DSPHASEN=31 and EOSDCDT ne . and dsdecodn not in (. 2)
and (VAX201DT ne . or VAX202DT ne .) and ((unblnddt ne . and
FDA-CBER-2022-5812-0072278
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] eosdcdt>=unblnddt) or eosdcdt=eotxdcdt) and index(armcd, 'PLACEBO');
by _datasrt _cat;
run;
data _denom34;
set _denom34;
by _datasrt _cat;
label count='count';
_trt=1;
count=&_trt1.;
output;
_trt=2;
count=&_trt2.;
output;
_trt=3;
count=&_trt3.;
output;
run;data _denomf34;
_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=_denom34 out=_denomin34(drop=_name_ _label_) prefix=_trt;
by _datasrt _cat;
var count;
id _trt;
run;proc sort data=_pct34 out=_expv34 (keep=_datasrt _blcksrt DSDECODN) nodupkey;
by _datasrt _blcksrt DSDECODN;
run;proc sort data=_expv34;
by _datasrt _blcksrt DSDECODN;
run;data _frame34;
set _expv34;
by _datasrt _blcksrt DSDECODN;
if first._blcksrt then
_catord=0;
_catord + 1;
_trt=1;
_cat=1;
FDA-CBER-2022-5812-0072279
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] output;
_trt=2;
_cat=1;
output;
_trt=3;
_cat=1;
output;
run;
proc sort data=_frame34;
by _datasrt _blcksrt _cat DSDECODN _trt;
run;proc sort data=_pct34;
by _datasrt _blcksrt _cat DSDECODN _trt;
run;data _pct34;
merge _frame34(in=_inframe) _pct34;
by _datasrt _blcksrt _cat DSDECODN _trt;
if _inframe;
if count=. then
count=0;
run;proc sort data=_pct34;
by _datasrt _blcksrt DSDECODN;
run;data _miss34(keep=_datasrt _blcksrt DSDECODN totcount);
set _pct34;
where DSDECODN=9998;
retain totcount;
by _datasrt _blcksrt DSDECODN;
if first.DSDECODN then
totcount=0;
totcount=totcount+count;
if last.DSDECODN;
run;data _pct34(drop=totcount);
merge _pct34 _miss34;
by _datasrt _blcksrt DSDECODN;
if totcount=0 then
delete;
run;proc sort data=_denomf34;
by _datasrt _cat;
FDA-CBER-2022-5812-0072280
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]run;
proc sort data=_denomin34;
by _datasrt _cat;
run;
data _denomin34;
merge _denomf34(in=_inframe) _denomin34;
by _datasrt _cat;
if _inframe;
_blcksrt=9;
run;proc sort data=_pct34;
by _datasrt _cat;
run;data _pct34;
if 0 then
set _basetemplate;
merge _denomin34(in=_a) _pct34;
by _datasrt _cat;
if _a;
_varname="DSDECODN ";
_vrlabel="Reason for withdrawal from the study ";
_rwlabel=put(DSDECODN, dsdecod.);
if DSDECODN=9998 then
do;
_rwlabel="Missing ";
_catord=9998;
end;
else if DSDECODN=9999 then
do;
_rwlabel="Total ";
_catord=9999;
end;
if _catord=. then
_catord=9997;
run;proc sort data=_pct34;
by _datasrt _blcksrt _catord DSDECODN _trt _cat;
run;data _base34;
length _catlabl $200;
set _pct34 end=eof;
by _datasrt _blcksrt _catord DSDECODN _trt _cat;
retain _rowsrt 4 _rowmax 0;
array _trtcnt(*) _trt1-_trt4;
FDA-CBER-2022-5812-0072281
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] 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.DSDECODN 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=8;
_dptindt=4;
if _trt=3 +1 then
FDA-CBER-2022-5812-0072282
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _trt=9999;
if eof then
call symput('_rowsrt', compress(put(_rowmax, 4.)));
_direct="TOP ";
_p=2;
run;
/* Set together */
data _final;
set _base1 _base2 _base3 _base4 _base5 _base6 _base7 _base8 _base9 _base10
_base11 _base12 _base13 _base14 _base15 _base16 _base17 _base18 _base19
_base20 _base21 _base22 _base23 _base24 _base25 _base26 _base27 _base28
_base29 _base30 _base31 _base32 _base33 _base34;
run;
proc sort data=_final;
by _datasrt _blcksrt _rowsrt;
run;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;
if _rowjump=. then
_rowjump=1;
if first._blcksrt then
do;
_token=repeat(' ', 99);
_count=1;
FDA-CBER-2022-5812-0072283
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _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;
_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;
_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;
FDA-CBER-2022-5812-0072284
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _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;data _sph (keep=name _s_col _e_col _splabl);
length _splabl $ 200 _s_col $ 40 _e_col $ 40 name $ 40;
_s_col=' ';
_e_col=' ';
_splabl=' ';
name=' ';
_s_col="TRT1";
_e_col="TRT2";
name=_s_col;
_splabl="Vaccine Group (as Randomized)~{line}";
output _sph;
name=_e_col;
output _sph;
_s_col="TRT4";
_e_col="TRT5";
name=_s_col;
_splabl="Vaccine Group (as Randomized)~{line}";
output _sph;
name=_e_col;
output _sph;
run;data _sph;
set _sph;
_s_col_num=input(translate(_s_col, " ", "TRT"), best.);
FDA-CBER-2022-5812-0072285
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _e_col_num=input(translate(_e_col, " ", "TRT"), best.);
run;
proc sort data=_sph (where=(_s_col=name)) out=_span_start;
by _s_col_num descending _e_col_num;
run;data _span_start;
retain _span_hdr_order 1;
set _span_start;
by _s_col_num descending _e_col_num;
if (first._s_col_num) then
_span_hdr_order=1;
else
_span_hdr_order=_span_hdr_order + 1;
run;proc sort data=_sph (where=(_e_col=name)) out=_span_end;
by _e_col_num descending _s_col_num;
run;data _span_end;
retain _span_hdr_order 1;
set _span_end;
by _e_col_num descending _s_col_num;
if (first._e_col_num) then
_span_hdr_order=1;
else
_span_hdr_order=_span_hdr_order + 1;
run;data _sph;
set _span_start _span_end;
run;proc sort data=_sph out=_sph nodupkey;
by _s_col_num descending _e_col_num _s_col _e_col _splabl name;
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 outdata1;
length _rvalue $800;
set _final rspon end=eof;
_rwindt=sum(_indent, _dptindt);
if _rwindt <=0 then
FDA-CBER-2022-5812-0072286
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] _rvalue=_rwlabel;
else
/*
_rvalue=repeat(byte(160), _rwindt-1)||_rwlabel; */
_rvalue=repeat('~{nbspace 1}', _rwindt-1)||_rwlabel;
_dummy=1;
if _trt=. then
_trt=1;
run;
proc sort data=outdata1;
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;data outdata1;
set outdata1(rename=(_cvalue=_cvalue11));
_fixvar=1;
_fix2var=1;
if index(_cvalue11, "(") then
do;
if substr(_cvalue11, length(_cvalue11), 1) ne ")" then
_cvalue=_cvalue11||")";
else
_cvalue=_cvalue11;
end;
else if not missing(_cvalue11) then
_cvalue=_cvalue11;
run;proc sort data=outdata1;
by _datasrt _trt _blcksrt _rowsrt;
run;proc sort data=outdata1 out=_pre_transposed;
by _fixvar _fix2var _datasrt _blcksrt _rowsrt _rvalue _trt;
run;data _pre_transposed;
set _pre_transposed;
FDA-CBER-2022-5812-0072287
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if _trt=9999 then
_trt=3 +1;
run;
proc sql noprint;
select min(_blcksrt) into: openord1 from _pre_transposed where
index(upcase(_rwlabel), 'RANDOMIZED TO BNT162B2');
select min(_blcksrt) into: openord2 from _pre_transposed where
index(upcase(_rwlabel), 'RANDOMIZED TO PLACEBO');
select max(_blcksrt) into: openord3 from _pre_transposed;
select max(_column) into: totnx from _pre_transposed;
select max(_trt) into: maxtrtx from _pre_transposed;
quit;data _pre_transposed;
set _pre_transposed;
if &openord1.<=_blcksrt<&openord2. and (_trt=&maxtrtx. or (_trt=2 and
count=0)) then
_cvalue='';
if &openord2.<=_blcksrt<=&openord3. and (_trt=&maxtrtx. or (_trt=1 and
count=0)) then
_cvalue='';
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;data maxtrtv;
set _pre_transposed;
if _trt=3;
run;proc transpose data=maxtrtv out=_cntsort (drop=_name_) prefix=cntsort;
by _fixvar _fix2var _datasrt _blcksrt _rowsrt _rvalue;
var count;
run;data _column_transposed;
merge _column_transposed(in=a) _cntsort;
by _fixvar _fix2var _datasrt _blcksrt _rowsrt _rvalue;
if a;
cntsort=input(cntsort1, best.);
drop cntsort1;
run;
FDA-CBER-2022-5812-0072288
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]proc sort;
by _fixvar _fix2var _datasrt _blcksrt descending cntsort _rowsrt _rvalue;
run;
data _column_transposed;
set _column_transposed;
by _fixvar _fix2var _datasrt _blcksrt descending cntsort _rowsrt _rvalue;
if _blcksrt=2 then
do;
if _rowsrt>1.5 then
do;
if first._blcksrt then
srt=1;
else
srt+1;
_rowsrt=1.5+srt;
if index(upcase(_rvalue), 'OTHER')>0 then
_rowsrt=999;
if cntsort=0 then
delete;
end;
end;
if _blcksrt=4 then
do;
if _rowsrt>4.5 then
do;
if first._blcksrt then
srt=1;
else
srt+1;
_rowsrt=4.5+srt;
if index(upcase(_rvalue), 'OTHER')>0 then
_rowsrt=999;
if cntsort=0 then
delete;
end;
end;
if _blcksrt=5 then
do;
if _rowsrt>7.5 then
do;
FDA-CBER-2022-5812-0072289
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM] if first._blcksrt then
srt=1;
else
srt+1;
_rowsrt=7.5+srt;
if index(upcase(_rvalue), 'OTHER')>0 then
_rowsrt=999;
if cntsort=0 then
delete;
end;
end;
if _blcksrt=7 then
do;
if _rowsrt>1.5 then
do;
if first._blcksrt then
srt=1;
else
srt+1;
_rowsrt=1.5+srt;
if index(upcase(_rvalue), 'OTHER')>0 then
_rowsrt=999;
if cntsort=0 then
delete;
end;
end;
if _blcksrt=9 then
do;
if _rowsrt>4.5 then
do;
if first._blcksrt then
srt=1;
else
srt+1;
_rowsrt=4.5+srt;
if index(upcase(_rvalue), 'OTHER')>0 then
_rowsrt=999;
if cntsort=0 then
delete;
end;
end;
drop srt cntsort;
FDA-CBER-2022-5812-0072290
file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]run;
proc sort;
by _fixvar _fix2var _datasrt _blcksrt _rowsrt _rvalue;
run;
proc contents data=_column_transposed
out=_col_labels (where=(upcase(name)=: "TRT") keep=name) noprint;
run;data _col_labels;
length name $ 40;
set _col_labels end=eof;
_sort_order=_n_;
name=upcase(name);
if eof then
call
…[truncated]