ADEX

Exposure Analysis Dataset

BASIC DATA STRUCTURE · one record per subject per parameter · keys STUDYID, USUBJID, PARAMCD

Variables

Program adex.sas

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

/*==== 00-header ====*/
/*----------------------------------------------------------------------------
  Data set : ADEX (Exposure Analysis Dataset)
  Reporting effort : CSR
  SDTM     : EX
  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 EX records, with the subject's TRTSDT, TRTEDT, STUDYID, USUBJID, SUBJID, SITEID, AGE, SEX, RACE, SAFFL, TRT01P, TRT01A, TRT01AN from ADSL. */
proc sort data=sdtm.ex(keep=studyid usubjid exdose exdosu exdosfrq exstdtc exendtc) out=work._ds; by usubjid; run;
proc sort data=adam.adsl(keep=usubjid trtsdt trtedt studyid usubjid subjid siteid age sex race saffl trt01p trt01a trt01an) out=work._adsl; by usubjid; run;
data work._ds;
  merge work._ds(in=_in) work._adsl;
  by usubjid;
  if _in;
  length trta $200;
  trta = trt01a;
  trtan = trt01an;
run;

/*==== 20-parameters ====*/
/* ADEX: each treated subject's exposure from SDTM.EX (records with a dose, placebo's 0 included), in date order:
   TRTDURD  treatment duration: first dose to last + 1 day (a dose every n days: the last administration + n days)
   NADMIN   administrations: each day of a daily regimen (QD; BID twice ...), each record otherwise
   CUMDOSE  cumulative dose: EXDOSE x the record's administrations
   DOSEINT  dose intensity: cumulative dose / duration, per day (daily regimen) or per week (none for single administrations)
   PDOSEINT planned dose intensity: the first record's dose by its frequency, in the same unit
   RDI      relative dose intensity (%): 100 x DOSEINT / PDOSEINT (none when nothing was planned: placebo)
   NDOSRED  dose reductions: records with a lower dose than the record before
   NDOSINT  interruptions: a gap between records of a daily regimen; an administration more than 0.5 of its
            interval late otherwise. */
data work._exrec;
  set sdtm.ex(keep=usubjid exdose exdosu exdosfrq exstdtc exendtc where=(not missing(exdose)));
  _st = input(substr(exstdtc, 1, 10), ?? yymmdd10.);
  _en = input(substr(exendtc, 1, 10), ?? yymmdd10.);
  if missing(_st) then delete;
  if missing(_en) or _en < _st then _en = _st;
  /* The regimen: administrations a day (daily), or the days between them. */
  select (upcase(strip(exdosfrq)));
    when ('QD', 'DAILY', 'Q24H') do; _every = 1; _perday = 1; end;
    when ('BID', 'Q12H') do; _every = 1; _perday = 2; end;
    when ('TID', 'Q8H') do; _every = 1; _perday = 3; end;
    when ('QID', 'Q6H') do; _every = 1; _perday = 4; end;
    when ('QW', 'Q1W', 'WEEKLY') do; _every = 7; _perday = 0; end;
    when ('Q2W', 'EVERY 2 WEEKS') do; _every = 14; _perday = 0; end;
    when ('Q3W', 'EVERY 3 WEEKS') do; _every = 21; _perday = 0; end;
    when ('Q4W', 'EVERY 4 WEEKS') do; _every = 28; _perday = 0; end;
    otherwise do; _every = 0; _perday = 0; end;
  end;
  if _every = 1 then _admin = (_en - _st + 1) * _perday;
  else _admin = 1;
run;
proc sort data=work._exrec; by usubjid _st; run;
data work._exp(keep=usubjid paramcd param aval avalu);
  set work._exrec;
  by usubjid;
  length paramcd $8 param $60 avalu $20 _unit $20 _per $10;
  retain _first _lastst _lasten _cum _n _red _int _prev _planned _plannedevery _plannedper _unit;
  if first.usubjid then do;
    _first = _st; _cum = 0; _n = 0; _red = 0; _int = 0; _prev = .; _lastst = .; _lasten = .;
    _planned = exdose; _plannedevery = _every; _plannedper = _perday; _unit = exdosu;
  end;
  _cum = _cum + exdose * _admin;
  _n = _n + _admin;
  if not missing(_prev) and exdose < _prev then _red = _red + 1;
  if not missing(_lastst) then do;
    if _plannedevery = 1 and _st > _lasten + 1 then _int = _int + 1;
    else if _plannedevery > 1 and _st - _lastst > _plannedevery * (1 + 0.5) then _int = _int + 1;
  end;
  _prev = exdose;
  _lastst = _st;
  _lasten = max(_lasten, _en);
  if last.usubjid then do;
    if _plannedevery > 1 then _dur = _lastst - _first + _plannedevery;
    else _dur = _lasten - _first + 1;
    /* Intensities per day for a daily regimen, per week otherwise. */
    if _plannedevery > 1 then do; _days = 7; _per = '/week'; end;
    else do; _days = 1; _per = '/day'; end;
    paramcd = 'TRTDURD'; param = 'Treatment Duration (days)'; aval = _dur; avalu = 'days'; output;
    paramcd = 'NADMIN'; param = 'Number of Administrations'; aval = _n; avalu = ''; output;
    paramcd = 'CUMDOSE'; param = cats('Cumulative Dose (', _unit, ')'); aval = _cum; avalu = _unit; output;
    /* Intensities for a regimen with a frequency (not single administrations). */
    if _plannedevery > 0 then do;
      paramcd = 'DOSEINT'; param = cats('Dose Intensity (', _unit, _per, ')'); aval = _cum / _dur * _days; avalu = cats(_unit, _per); output;
      if _plannedevery = 1 then _pdi = _planned * _plannedper;
      else _pdi = _planned / _plannedevery * 7;
      paramcd = 'PDOSEINT'; param = cats('Planned Dose Intensity (', _unit, _per, ')'); aval = _pdi; avalu = cats(_unit, _per); output;
      paramcd = 'RDI'; param = 'Relative Dose Intensity (%)'; avalu = '%';
      if _pdi > 0 then aval = 100 * (_cum / _dur * _days) / _pdi;
      else aval = .;
      output;
    end;
    paramcd = 'NDOSRED'; param = 'Number of Dose Reductions'; aval = _red; avalu = ''; output;
    paramcd = 'NDOSINT'; param = 'Number of Dose Interruptions'; aval = _int; avalu = ''; output;
  end;
run;
/* With the subject's variables (ADSL's): one record of each subject's (the records so far may be EX's). */
proc sort data=work._exp; by usubjid paramcd; run;
proc sort data=work._ds out=work._subj nodupkey; by usubjid; run;
data work._ds;
  merge work._exp(in=_in) work._subj;
  by usubjid;
  if _in;
run;

/*==== 80-sequence ====*/
/* ASEQ: 1, 2, ... per subject, by studyid  paramcd. */
proc sort data=work._ds; by usubjid studyid  paramcd; run;
data work._ds;
  set work._ds;
  by usubjid;
  if first.usubjid then aseq = 0;
  aseq + 1;
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;
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, 'USUBJID') > 0 then do; _ren = catx(' ', _ren, 'USUBJID=_rz2'); _asg = catx(' ', _asg, 'USUBJID = _rz2;');
    _siz = catx(' ', _siz, '_len2 = max(_len2, lengthn(USUBJID));'); end;
  if varnum(_dsid, 'SUBJID') > 0 then do; _ren = catx(' ', _ren, 'SUBJID=_rz3'); _asg = catx(' ', _asg, 'SUBJID = _rz3;');
    _siz = catx(' ', _siz, '_len3 = max(_len3, lengthn(SUBJID));'); end;
  if varnum(_dsid, 'SITEID') > 0 then do; _ren = catx(' ', _ren, 'SITEID=_rz4'); _asg = catx(' ', _asg, 'SITEID = _rz4;');
    _siz = catx(' ', _siz, '_len4 = max(_len4, lengthn(SITEID));'); end;
  if varnum(_dsid, 'SEX') > 0 then do; _ren = catx(' ', _ren, 'SEX=_rz5'); _asg = catx(' ', _asg, 'SEX = _rz5;');
    _siz = catx(' ', _siz, '_len5 = max(_len5, lengthn(SEX));'); end;
  if varnum(_dsid, 'RACE') > 0 then do; _ren = catx(' ', _ren, 'RACE=_rz6'); _asg = catx(' ', _asg, 'RACE = _rz6;');
    _siz = catx(' ', _siz, '_len6 = max(_len6, lengthn(RACE));'); 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, 'TRT01P') > 0 then do; _ren = catx(' ', _ren, 'TRT01P=_rz8'); _asg = catx(' ', _asg, 'TRT01P = _rz8;');
    _siz = catx(' ', _siz, '_len8 = max(_len8, lengthn(TRT01P));'); end;
  if varnum(_dsid, 'TRT01A') > 0 then do; _ren = catx(' ', _ren, 'TRT01A=_rz9'); _asg = catx(' ', _asg, 'TRT01A = _rz9;');
    _siz = catx(' ', _siz, '_len9 = max(_len9, lengthn(TRT01A));'); end;
  if varnum(_dsid, 'TRTA') > 0 then do; _ren = catx(' ', _ren, 'TRTA=_rz10'); _asg = catx(' ', _asg, 'TRTA = _rz10;');
    _siz = catx(' ', _siz, '_len10 = max(_len10, lengthn(TRTA));'); end;
  if varnum(_dsid, 'PARAMCD') > 0 then do; _ren = catx(' ', _ren, 'PARAMCD=_rz11'); _asg = catx(' ', _asg, 'PARAMCD = _rz11;');
    _siz = catx(' ', _siz, '_len11 = max(_len11, lengthn(PARAMCD));'); end;
  if varnum(_dsid, 'PARAM') > 0 then do; _ren = catx(' ', _ren, 'PARAM=_rz12'); _asg = catx(' ', _asg, 'PARAM = _rz12;');
    _siz = catx(' ', _siz, '_len12 = max(_len12, lengthn(PARAM));'); end;
  if varnum(_dsid, 'AVALU') > 0 then do; _ren = catx(' ', _ren, 'AVALU=_rz13'); _asg = catx(' ', _asg, 'AVALU = _rz13;');
    _siz = catx(' ', _siz, '_len13 = max(_len13, lengthn(AVALU));'); 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;
  &_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);
  end;
run;
data adam.adex(label="Exposure Analysis Dataset");
  attrib
    STUDYID  length=$&_len1 label="Study Identifier"
    USUBJID  length=$&_len2 label="Unique Subject Identifier"
    SUBJID   length=$&_len3 label="Subject Identifier for the Study"
    SITEID   length=$&_len4 label="Study Site Identifier"
    AGE      length=8 label="Age"
    SEX      length=$&_len5 label="Sex"
    RACE     length=$&_len6 label="Race"
    SAFFL    length=$&_len7 label="Safety Population Flag"
    TRT01P   length=$&_len8 label="Planned Treatment for Period 01"
    TRT01A   length=$&_len9 label="Actual Treatment for Period 01"
    TRTA     length=$&_len10 label="Actual Treatment"
    TRTAN    length=8 label="Actual Treatment (N)"
    TRTSDT   length=8 label="Date of First Exposure to Treatment" format=DATE9.
    TRTEDT   length=8 label="Date of Last Exposure to Treatment" format=DATE9.
    PARAMCD  length=$&_len11 label="Parameter Code"
    PARAM    length=$&_len12 label="Parameter"
    AVAL     length=8 label="Analysis Value"
    AVALU    length=$&_len13 label="Analysis Value Unit"
    ASEQ     length=8 label="Analysis Sequence Number"
  ;
  set work._final&_ren;
  &_asg
  keep STUDYID USUBJID SUBJID SITEID AGE SEX RACE SAFFL TRT01P TRT01A TRTA TRTAN TRTSDT TRTEDT PARAMCD PARAM AVAL AVALU ASEQ;
run;
proc sort data=adam.adex; by STUDYID USUBJID PARAMCD; run;

Data (first 20 of 2,400 records, simulated)