ADVS

Vital Signs Analysis Dataset

BASIC DATA STRUCTURE · one record per subject per parameter per analysis visit per analysis timepoint · keys USUBJID, PARAMCD, AVISIT, ATPT

Variables

Program advs.sas

Version 1, written from Clinwright's patterns, 2026-10-17, checks passed.

/*==== 00-header ====*/
/*----------------------------------------------------------------------------
  Data set : ADVS (Vital Signs Analysis Dataset)
  Reporting effort : CSR
  SDTM     : VS
  ADaM     : ADSL
  The header and the finalize step follow from the specification.
----------------------------------------------------------------------------*/
libname sdtm "/work/sdtm" access=readonly;
libname adam "/work/adam";
options validvarname=upcase nofmterr msglevel=i;

/*==== 10-inputs ====*/
/* The VS records of the parameters PARAMCD's codelist lists, with the subject's TRTSDT, TRTEDT, STUDYID, SITEID, AGE, AGEGR1, AGEGR1N, RACE, RACEN, SEX, SAFFL, TRT01P, TRT01PN, TRT01A, TRT01AN from ADSL. */
proc sort data=sdtm.vs(keep=studyid usubjid vsseq vstestcd vstest vsstresn vslobxfl visitnum visit vsdtc vsdy where=(vstestcd in ('SYSBP', 'DIABP', 'PULSE', 'WEIGHT', 'HEIGHT', 'TEMP'))) out=work._ds; by usubjid; run;
proc sort data=adam.adsl(keep=usubjid trtsdt trtedt studyid siteid age agegr1 agegr1n race racen sex saffl trt01p trt01pn trt01a trt01an) out=work._adsl; by usubjid; run;
data work._ds;
  merge work._ds(in=_in) work._adsl;
  by usubjid;
  if _in;
  length trtp $200;
  trtp = trt01p;
  trtpn = trt01pn;
  length trta $200;
  trta = trt01a;
  trtan = trt01an;
  length paramcd $200;
  paramcd = vstestcd;
  length param $200;
  select (upcase(vstestcd));
    when ('SYSBP') param = 'Systolic Blood Pressure (mmHg)';
    when ('DIABP') param = 'Diastolic Blood Pressure (mmHg)';
    when ('PULSE') param = 'Pulse Rate (beats/min)';
    when ('WEIGHT') param = 'Weight (kg)';
    when ('HEIGHT') param = 'Height (cm)';
    when ('TEMP') param = 'Temperature (C)';
    otherwise param = '';
  end;
  if param = '' then do;
  select (upcase(vstest));
    when ('SYSTOLIC BLOOD PRESSURE', 'SYSTOLIC BLOOD PRESSURE (MMHG)') param = 'Systolic Blood Pressure (mmHg)';
    when ('DIASTOLIC BLOOD PRESSURE', 'DIASTOLIC BLOOD PRESSURE (MMHG)') param = 'Diastolic Blood Pressure (mmHg)';
    when ('PULSE RATE', 'PULSE RATE (BEATS/MIN)') param = 'Pulse Rate (beats/min)';
    when ('WEIGHT', 'WEIGHT (KG)') param = 'Weight (kg)';
    when ('HEIGHT', 'HEIGHT (CM)') param = 'Height (cm)';
    when ('TEMPERATURE', 'TEMPERATURE (C)') param = 'Temperature (C)';
    otherwise param = vstest;
  end;
  end;
  ady = vsdy;
  length atpt $200;
  /* VS.VSTPT is not in the data: ATPT stays empty. */
  aval = vsstresn;
  length basetype $200;
  /* VS.VSTPT is not in the data: BASETYPE stays empty. */
  length ablfl $200;
  /* VS.VSBLFL is not in the data: VS.VSLOBXFL, its name in the other SDTMIG version. */
  ablfl = vslobxfl;
run;

/*==== 20-parameters ====*/
/* PARAMN: the code of PARAM. */
proc format;
  invalue paramn_ (upcase just)

    "SYSTOLIC BLOOD PRESSURE (MMHG)" = 1

    "DIASTOLIC BLOOD PRESSURE (MMHG)" = 2

    "PULSE RATE (BEATS/MIN)" = 3

    "WEIGHT (KG)" = 4

    "HEIGHT (CM)" = 5

    "TEMPERATURE (C)" = 6

    other = .;
run;
data work._ds;
  set work._ds;
  if param ne '' then paramn = input(param, paramn_.);
run;

/* ATPTN: the code of ATPT. */
proc format;
  invalue atptn_ (upcase just)

    "AFTER LYING DOWN FOR 5 MINUTES" = 815

    "AFTER STANDING FOR 1 MINUTE" = 816

    "AFTER STANDING FOR 3 MINUTES" = 817

    other = .;
run;
data work._ds;
  set work._ds;
  if atpt ne '' then atptn = input(atpt, atptn_.);
run;

/*==== 30-timing ====*/
/* ADT: VS.VSDTC as a SAS date. */
data work._ds;
  set work._ds;
  length _dtc $10;
  _dtc = vsdtc; /* (its first 10 characters: SUBSTR would complain of a shorter variable) */
  if length(_dtc) = 10 then adt = input(_dtc, ?? yymmdd10.);

  format adt date9.;
  drop _dtc;
run;

/*==== 40-visits ====*/
/* AVISIT: from the scheduled visit, by its name; other visits get none. */
data work._ds;
  set work._ds;
  length avisit $40;

  select (upcase(visit));

    when ("CYCLE 1 DAY 1") do; avisitn = 0; avisit = "Baseline"; end;

    when ("WEEK 3") do; avisitn = 3; avisit = "Week 3"; end;

    when ("WEEK 6") do; avisitn = 6; avisit = "Week 6"; end;

    when ("WEEK 9") do; avisitn = 9; avisit = "Week 9"; end;

    when ("WEEK 12") do; avisitn = 12; avisit = "Week 12"; end;

    when ("WEEK 15") do; avisitn = 15; avisit = "Week 15"; end;

    when ("WEEK 18") do; avisitn = 18; avisit = "Week 18"; end;

    when ("WEEK 21") do; avisitn = 21; avisit = "Week 21"; end;

    when ("WEEK 24") do; avisitn = 24; avisit = "Week 24"; end;

    when ("WEEK 27") do; avisitn = 27; avisit = "Week 27"; end;

    when ("WEEK 30") do; avisitn = 30; avisit = "Week 30"; end;

    when ("WEEK 33") do; avisitn = 33; avisit = "Week 33"; end;

    when ("WEEK 36") do; avisitn = 36; avisit = "Week 36"; end;

    when ("WEEK 39") do; avisitn = 39; avisit = "Week 39"; end;

    when ("WEEK 42") do; avisitn = 42; avisit = "Week 42"; end;

    when ("WEEK 45") do; avisitn = 45; avisit = "Week 45"; end;

    when ("WEEK 48") do; avisitn = 48; avisit = "Week 48"; end;

    when ("END OF TREATMENT") do; avisitn = 99; avisit = "End of Treatment"; end;

    otherwise call missing(avisit, avisitn);
  end;


run;

/* End of Treatment: each subject's last scheduled record after baseline, as a record of its own. */
proc sort data=work._ds(where=(avisitn > 0)) out=work._eot;
  by usubjid paramcd atptn adt visitnum;
run;
data work._eot;
  set work._eot;
  by usubjid paramcd atptn;
  if last.atptn;
  avisit = "End of Treatment";
  avisitn = 99;
run;
data work._ds;
  set work._ds work._eot;
run;
proc sort data=work._ds; by usubjid; run;

/*==== 50-baseline ====*/
/* BASE: AVAL of the baseline record (ABLFL = 'Y'), per subject and PARAMCD, BASETYPE. */
proc sort data=work._ds; by usubjid paramcd basetype; run;
data work._base(keep=usubjid paramcd basetype base);
  set work._ds(where=(ablfl = 'Y'));
  base = aval;
run;
data work._ds;
  merge work._ds work._base;
  by usubjid paramcd basetype;
run;

/* The baseline record without an analysis visit (a screening value, the test not done on the day of the first dose): the Baseline analysis visit. */
data work._ds;
  set work._ds;
  if ablfl = 'Y' and missing(avisit) then do; avisit = 'Baseline'; avisitn = 0; _blvis = 1; end;
run;
/* (Then a record of the same subject and PARAMCD, BASETYPE at the Baseline visit that is not the baseline, the day of the first dose without a value: no analysis visit.) */
proc sort data=work._ds; by usubjid paramcd basetype descending _blvis; run;
data work._ds;
  set work._ds;
  by usubjid paramcd basetype;
  retain _blmov;
  if first.basetype then _blmov = (_blvis = 1);
  if _blmov and ablfl ne 'Y' and avisit = 'Baseline' then call missing(avisit, avisitn);
  drop _blvis _blmov;
run;

/* BASE as the data set keeps it, for what is derived from it. */
data work._ds; set work._ds; if not missing(base) then base = round(base, 1e-2); run;

/* CHG: AVAL - BASE, after baseline only. */
data work._ds;
  set work._ds;
  if nmiss(aval, base) = 0 and ablfl ne 'Y' and adt > trtsdt then chg = aval - base;
run;

/* CHG as the data set keeps it, for what is derived from it. */
data work._ds; set work._ds; if not missing(chg) then chg = round(chg, 1e-2); run;

/* PCHG: 100 * CHG / BASE, where BASE is not 0. */
data work._ds;
  set work._ds;
  if not missing(chg) and base not in (., 0) then pchg = 100 * chg / base;
run;

/*==== 60-flags ====*/
/* ANL01FL: Y on the records with an analysis visit. */
data work._ds;
  set work._ds;
  length anl01fl $1;
  if not missing(avisit) then anl01fl = 'Y';
  else anl01fl = '';
run;

/*==== 89-final ====*/
/* The data set as derived; the finalize step keeps the specification's variables. */
data work._final;
  set work._ds;
run;

/*==== 90-finalize ====*/
/* 90-finalize: from the specification; the variables, their order and attributes are not changed here. */
/* The text variables the specification gives no length: as long as their longest value (at least 1). */
%let _len1 = 1; %let _len2 = 1; %let _len3 = 1; %let _len4 = 1; %let _len5 = 1; %let _len6 = 1; %let _len7 = 1; %let _len8 = 1; %let _len9 = 1; %let _len10 = 1; %let _len11 = 1; %let _len12 = 1; %let _len13 = 1; %let _len14 = 1; %let _len15 = 1; %let _len16 = 1; %let _len17 = 1;
data _null_;
  length _ren _asg _siz $32767;
  _dsid = open('work._final');
  if varnum(_dsid, 'STUDYID') > 0 then do; _ren = catx(' ', _ren, 'STUDYID=_rz1'); _asg = catx(' ', _asg, 'STUDYID = _rz1;');
    _siz = catx(' ', _siz, '_len1 = max(_len1, lengthn(STUDYID));'); end;
  if varnum(_dsid, 'SITEID') > 0 then do; _ren = catx(' ', _ren, 'SITEID=_rz2'); _asg = catx(' ', _asg, 'SITEID = _rz2;');
    _siz = catx(' ', _siz, '_len2 = max(_len2, lengthn(SITEID));'); end;
  if varnum(_dsid, 'USUBJID') > 0 then do; _ren = catx(' ', _ren, 'USUBJID=_rz3'); _asg = catx(' ', _asg, 'USUBJID = _rz3;');
    _siz = catx(' ', _siz, '_len3 = max(_len3, lengthn(USUBJID));'); end;
  if varnum(_dsid, 'AGEGR1') > 0 then do; _ren = catx(' ', _ren, 'AGEGR1=_rz4'); _asg = catx(' ', _asg, 'AGEGR1 = _rz4;');
    _siz = catx(' ', _siz, '_len4 = max(_len4, lengthn(AGEGR1));'); end;
  if varnum(_dsid, 'RACE') > 0 then do; _ren = catx(' ', _ren, 'RACE=_rz5'); _asg = catx(' ', _asg, 'RACE = _rz5;');
    _siz = catx(' ', _siz, '_len5 = max(_len5, lengthn(RACE));'); end;
  if varnum(_dsid, 'SEX') > 0 then do; _ren = catx(' ', _ren, 'SEX=_rz6'); _asg = catx(' ', _asg, 'SEX = _rz6;');
    _siz = catx(' ', _siz, '_len6 = max(_len6, lengthn(SEX));'); end;
  if varnum(_dsid, 'SAFFL') > 0 then do; _ren = catx(' ', _ren, 'SAFFL=_rz7'); _asg = catx(' ', _asg, 'SAFFL = _rz7;');
    _siz = catx(' ', _siz, '_len7 = max(_len7, lengthn(SAFFL));'); end;
  if varnum(_dsid, 'TRTP') > 0 then do; _ren = catx(' ', _ren, 'TRTP=_rz8'); _asg = catx(' ', _asg, 'TRTP = _rz8;');
    _siz = catx(' ', _siz, '_len8 = max(_len8, lengthn(TRTP));'); end;
  if varnum(_dsid, 'TRTA') > 0 then do; _ren = catx(' ', _ren, 'TRTA=_rz9'); _asg = catx(' ', _asg, 'TRTA = _rz9;');
    _siz = catx(' ', _siz, '_len9 = max(_len9, lengthn(TRTA));'); end;
  if varnum(_dsid, 'PARAMCD') > 0 then do; _ren = catx(' ', _ren, 'PARAMCD=_rz10'); _asg = catx(' ', _asg, 'PARAMCD = _rz10;');
    _siz = catx(' ', _siz, '_len10 = max(_len10, lengthn(PARAMCD));'); end;
  if varnum(_dsid, 'PARAM') > 0 then do; _ren = catx(' ', _ren, 'PARAM=_rz11'); _asg = catx(' ', _asg, 'PARAM = _rz11;');
    _siz = catx(' ', _siz, '_len11 = max(_len11, lengthn(PARAM));'); end;
  if varnum(_dsid, 'ATPT') > 0 then do; _ren = catx(' ', _ren, 'ATPT=_rz12'); _asg = catx(' ', _asg, 'ATPT = _rz12;');
    _siz = catx(' ', _siz, '_len12 = max(_len12, lengthn(ATPT));'); end;
  if varnum(_dsid, 'AVISIT') > 0 then do; _ren = catx(' ', _ren, 'AVISIT=_rz13'); _asg = catx(' ', _asg, 'AVISIT = _rz13;');
    _siz = catx(' ', _siz, '_len13 = max(_len13, lengthn(AVISIT));'); end;
  if varnum(_dsid, 'BASETYPE') > 0 then do; _ren = catx(' ', _ren, 'BASETYPE=_rz14'); _asg = catx(' ', _asg, 'BASETYPE = _rz14;');
    _siz = catx(' ', _siz, '_len14 = max(_len14, lengthn(BASETYPE));'); end;
  if varnum(_dsid, 'VISIT') > 0 then do; _ren = catx(' ', _ren, 'VISIT=_rz15'); _asg = catx(' ', _asg, 'VISIT = _rz15;');
    _siz = catx(' ', _siz, '_len15 = max(_len15, lengthn(VISIT));'); end;
  if varnum(_dsid, 'ANL01FL') > 0 then do; _ren = catx(' ', _ren, 'ANL01FL=_rz16'); _asg = catx(' ', _asg, 'ANL01FL = _rz16;');
    _siz = catx(' ', _siz, '_len16 = max(_len16, lengthn(ANL01FL));'); end;
  if varnum(_dsid, 'ABLFL') > 0 then do; _ren = catx(' ', _ren, 'ABLFL=_rz17'); _asg = catx(' ', _asg, 'ABLFL = _rz17;');
    _siz = catx(' ', _siz, '_len17 = max(_len17, lengthn(ABLFL));'); end;
  _rc = close(_dsid);
  if _ren ne '' then _ren = cats('(rename=(', _ren, '))');
  call symputx('_ren', _ren);
  call symputx('_asg', _asg);
  call symputx('_siz', _siz);
run;
data _null_;
  set work._final end=_end;
  retain _len1 1 _len2 1 _len3 1 _len4 1 _len5 1 _len6 1 _len7 1 _len8 1 _len9 1 _len10 1 _len11 1 _len12 1 _len13 1 _len14 1 _len15 1 _len16 1 _len17 1;
  &_siz
  if _end then do;
    call symputx('_len1', _len1);
    call symputx('_len2', _len2);
    call symputx('_len3', _len3);
    call symputx('_len4', _len4);
    call symputx('_len5', _len5);
    call symputx('_len6', _len6);
    call symputx('_len7', _len7);
    call symputx('_len8', _len8);
    call symputx('_len9', _len9);
    call symputx('_len10', _len10);
    call symputx('_len11', _len11);
    call symputx('_len12', _len12);
    call symputx('_len13', _len13);
    call symputx('_len14', _len14);
    call symputx('_len15', _len15);
    call symputx('_len16', _len16);
    call symputx('_len17', _len17);
  end;
run;
data adam.advs(label="Vital Signs Analysis Dataset");
  attrib
    STUDYID  length=$&_len1 label="Study Identifier"
    SITEID   length=$&_len2 label="Study Site Identifier"
    USUBJID  length=$&_len3 label="Unique Subject Identifier"
    AGE      length=8 label="Age"
    AGEGR1   length=$&_len4 label="Pooled Age Group 1"
    AGEGR1N  length=8 label="Pooled Age Group 1 (N)"
    RACE     length=$&_len5 label="Race"
    RACEN    length=8 label="Race (N)"
    SEX      length=$&_len6 label="Sex"
    SAFFL    length=$&_len7 label="Safety Population Flag"
    TRTSDT   length=8 label="Date of First Exposure to Treatment" format=DATE9.
    TRTEDT   length=8 label="Date of Last Exposure to Treatment" format=DATE9.
    TRTP     length=$&_len8 label="Planned Treatment"
    TRTPN    length=8 label="Planned Treatment (N)"
    TRTA     length=$&_len9 label="Actual Treatment"
    TRTAN    length=8 label="Actual Treatment (N)"
    PARAMCD  length=$&_len10 label="Parameter Code"
    PARAM    length=$&_len11 label="Parameter"
    PARAMN   length=8 label="Parameter (N)"
    ADT      length=8 label="Analysis Date" format=DATE9.
    ADY      length=8 label="Analysis Relative Day"
    ATPTN    length=8 label="Analysis Timepoint (N)"
    ATPT     length=$&_len12 label="Analysis Timepoint"
    AVISIT   length=$&_len13 label="Analysis Visit"
    AVISITN  length=8 label="Analysis Visit (N)"
    AVAL     length=8 label="Analysis Value"
    BASE     length=8 label="Baseline Value"
    BASETYPE length=$&_len14 label="Baseline Type"
    CHG      length=8 label="Change from Baseline"
    PCHG     length=8 label="Percent Change from Baseline"
    VISITNUM length=8 label="Visit Number"
    VISIT    length=$&_len15 label="Visit Name"
    VSSEQ    length=8 label="Sequence Number"
    ANL01FL  length=$&_len16 label="Analysis Flag 01"
    ABLFL    length=$&_len17 label="Baseline Record Flag"
  ;
  set work._final&_ren;
  &_asg
  if not missing(AVAL) then AVAL = round(AVAL, 1e-2);
  if not missing(BASE) then BASE = round(BASE, 1e-2);
  if not missing(CHG) then CHG = round(CHG, 1e-2);
  if not missing(PCHG) then PCHG = round(PCHG, 1e-1);
  if not missing(VISITNUM) then VISITNUM = round(VISITNUM, 1e-1);
  keep STUDYID SITEID USUBJID AGE AGEGR1 AGEGR1N RACE RACEN SEX SAFFL TRTSDT TRTEDT TRTP TRTPN TRTA TRTAN PARAMCD PARAM PARAMN ADT ADY ATPTN ATPT AVISIT AVISITN AVAL BASE BASETYPE CHG PCHG VISITNUM VISIT VSSEQ ANL01FL ABLFL;
run;
proc sort data=adam.advs; by USUBJID PARAMCD AVISIT ATPT; run;

Data (first 20 of 24,054 records, simulated)