125742 45 S211 M5 c4591001 A 6mth P addv sas

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file:///J/...5-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-addv-sas.txt[7/5/2023 10:22:49 AM]***********************************************************************************************;
**  Program Name    :  addv.sas                                                              **;**  Date Created    :  17Nov2021                                                             **;**  Programmer Name :                                                                  **;
**  Purpose         :  Create addv dataset                                                   **;**  Input data      :  dv suppdv adsl                                                        **;**  Output data     :  addv.sas7bdat                                                         **;***********************************************************************************************;options mprint mlogic symbolgen mprint symbolgen mlogic nocenter missing=" ";
proc datasets library=WORK kill nolist nodetails;
quit;
**Setup the environment**;
%let oprot=/Volumes/app/cdars/prod/sites/cdars4/prjC459/nda2_unblinded_esub/sbla1215_esub_sdtm/saseng/cdisc3_0/data/sdtm;%let protori=/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/analysis/eSUB;
libname dataprot "&oprot." access=readonly;
libname datvprot "&protori./data_vai" access=readonly;libname datvout "&prot./data_vai";libname viewpx "/Volumes/app/saseng/prod/cdisc3_0/view/" access=readonly;
proc printto print="&prot./output/addv.rpt" 
        log="&prot./logs/addv.log" new;run;
**** exit if not running a DP algorithm **************************************;proc sort data=dataprot.suppdv out=suppdv;
    by usubjid idvarval qnam;run;
proc transpose data=suppdv out=suppdv1(drop=_NAME_ _LABEL_);
    by usubjid idvarval;    var qval;    id qnam;    idlabel qlabel;run;
data suppdv1;
    set suppdv1;    dvseq=input(idvarval, best.);run;
proc sort;
    by usubjid dvseq;run;
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0072387
file:///J/...5-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-addv-sas.txt[7/5/2023 10:22:49 AM]proc sort data=dataprot.dv out=dv;
    by usubjid dvseq;run;
data _dv1;
    merge dv suppdv1;    by usubjid dvseq;
proc sort;
    by usubjid;run;
proc sort data=datvprot.adsl out=adsl;
    by usubjid;run;
data _dv2;
    merge _dv1(in=a) adsl(in=b);    by usubjid;    if a;    if agegr4n=1;run;
data _dv3;
    set _dv2;    format ASTDT date9. aphasdt date9. aphaedt date9.;    length aphase $40. aperiodc $20.;    label ASTDT='Analysis Start Date' APHASE='Phase' APERIOD='Period'         APERIODC='Period (C)' PREFL='Pre-treatment Flag' TRPFL='On Treatment Flag';    p2dt=min(VAX201DT, unblnddt);
    if dvstdtc ne "" then
        astdt=input(dvstdtc, yymmdd10.);
    if brthdt<=astdt<=(trtsdt-1) then
        do;            aphase='PRE-TREATMENT';        end;    else if (.<trtsdt<=astdt and p2dt=.) or (p2dt ne . and .<trtsdt<=astdt<p2dt)         then            do;            aphase='TREATMENT 01';        end;    else if .<p2dt<=astdt<trtedt+365 then        do;            aphase='TREATMENT 02';        end;
    if (trtsdt ne . and .<astdt and p2dt=.) or (trtsdt ne . and p2dt 
        ne . and .<astdt<p2dt) then            do;            aperiod=1;            aperiodc='Period 01';
FDA-CBER-2022-5812-0072388
file:///J/...5-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-addv-sas.txt[7/5/2023 10:22:49 AM]        end;
    else if .<p2dt<=astdt<=trtsdt+365 then
        do;            aperiod=2;            aperiodc='Period 02';        end;
    if astdt<trtsdt then
        prefl='Y';
    if substr(aphase, 1, 9)='TREATMENT' then
        TRPFL='Y';    else        TRPFL='N';run;
data final;
    retain studyid usubjid domain subjid siteid age sex race trtsdt trtedt arm         armcd actarm actarmcd trt01p trt01a trt01pn trt01an agegr1 agegr1n dvseq         dvspid dvterm dvterm1 dvdecod epoch actsite desgtor cape dvcat dvstdtc dvstdy         astdt prefl trpfl randfl phase phasen trtarn trtar trtprn trtpr COHORT         COHORTN DOSALVL DOSALVLN DOSPLVL DOSPLVLN DS3KFL AGEGR3N AGEGR3 AGEGR4N         AGEGR4 HIVFL AGETR01 TRTSDTM TRTEDTM TR01SDTM TR01EDTM TR02SDTM TR02EDTM         VAX101 VAX102 VAX10U VAX201 VAX202 VAX20U VAX20UDT UNBLNDDT SAFFL;    set _dv3;    keep studyid usubjid domain subjid siteid age sex race trtsdt trtedt arm armcd         actarm actarmcd trt01p trt01a trt01pn trt01an agegr1 agegr1n dvseq dvspid         dvterm dvterm1 dvdecod epoch actsite desgtor cape dvcat dvstdtc dvstdy astdt         prefl trpfl randfl phase phasen SAFFL COHORT COHORTN DOSALVL DOSALVLN DOSPLVL         DOSPLVLN DS3KFL AGEGR3N AGEGR3 AGEGR4N AGEGR4 HIVFL AGETR01 TRTSDTM TRTEDTM         TR01SDTM TR01EDTM TR02SDTM TR02EDTM VAX101 VAX102 VAX10U VAX201 VAX202 VAX20U         VAX20UDT UNBLNDDT;run;
proc sort data=final 
        out=datvout.addv(label='Protocol Deviations Analysis Dataset');    by USUBJID ASTDT;run;
proc printto;
run;
FDA-CBER-2022-5812-0072389