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Concomitant Medications



Clinical Trials: Concomitant Medications

Download Definition as
Download Submission Template as
Element NameData TypeSizeRequiredDescriptionValue RangeNotesAliases
subjectkeyGUIDRequiredThe NDAR Global Unique Identifier (GUID) for research subjectNDAR*guid
src_subject_idString20RequiredSubject ID how it's defined in lab/projectCATIEID, case_id, id, patid, pid, randid, subject_id, subjectid, subjid
interview_dateDateRequiredDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYYRequired fieldintvdate, visit_date
interview_ageIntegerRequiredAge in months at the time of the interview/test/sampling/imaging.0 :: 1260Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.bslage, intvage
genderString20RequiredSex of the subjectM;FM = Male; F = Female
othmed0aIntegerRecommendedDid the patient take any medications0;10 = No; 1 = Yes
drugtermString50RecommendedOriginal Drugterm
drgterm2String50RecommendedCombined DRUGTERM
shrtcodeString50RecommendedWHO Drug Dictionary, version 3Q 2000 numeric code identifying each drug corresponding to DRUGTERM
medcodeString25RecommendedCreated Medication codeconmedcode
atc1lev3String100RecommendedAnatomic-Therapeutic- Class 1, Level 3
atc2lev3String100RecommendedAnatomic-Therapeutic- Class 2, Level 3
startdyIntegerRecommendedStart Daycntr_startdat_x, datestrt
enddayIntegerRecommendedStop Daycntr_enddat_x, dateend
othmed2IntegerRecommended2. Adjunctive or Concomitant1;21 = Adjunctive; 2 = Concomitant
othmed2aIntegerRecommended2a. Primary Adjunctive1::101 = Insomnia; 2 = Anxiety; 3 = Agitation/Excitement; 4 = Aggression/Violence; 5 = Dysphoria/Depression; 6 = Catatonic Immobility; 7 = Substance Use Disorder; 8 = Cognitive Problems; 9 = Antipsychotic Cross-Titration; 10 = Out-of-Study Antipsychotic Use
othmed2bIntegerRecommended2b. Secondary Adjunctive1::101 = Insomnia; 2 = Anxiety; 3 = Agitation/Excitement; 4 = Aggression/Violence; 5 = Dysphoria/Depression; 6 = Catatonic Immobility; 7 = Substance Use Disorder; 8 = Cognitive Problems; 9 = Antipsychotic Cross-Titration; 10 = Out-of-Study Antipsychotic Use
othmed2cIntegerRecommended2c. Primary Concomitant11::2011 = Parkinsonism; 12 = Akathisia; 13 = Tardive Dyskinesia; 14 = Prolactin/Sexual; 15 = Weight Gain; 16 = Hyperglycemia/Diabetes; 17 = Hyperlipidemia; 18 = High Blood Pressure; 19 = Constipation; 20 = Other, specify
othmed2eIntegerRecommended2d. Secondary Concomitant11::2011 = Parkinsonism; 12 = Akathisia; 13 = Tardive Dyskinesia; 14 = Prolactin/Sexual; 15 = Weight Gain; 16 = Hyperglycemia/Diabetes; 17 = Hyperlipidemia; 18 = High Blood Pressure; 19 = Constipation; 20 = Other, specify
othmed4FloatRecommended3. Modal Daily Dose
othmed4aString10Recommended3a. Modal Daily Dose UnitsCA = CA - Capsules; GI = GI - Drops; IU = IU - International Units; TB = TB - Tablets; U = U - Units; gm = gm - Grams; mL = Ml - Milliliter [cc]; mcg = mcg - Micrograms; mg = mg - Milligrams
flagIntegerRecommendedBaseline Medication Flag
priflagIntegerRecommendedPrior Baseline Medication Flag
conflagIntegerRecommendedContinuous Baseline Medication Flag
postflagIntegerRecommendedPost-Baseline and in P1 Medication Flag
postflg2IntegerRecommendedPost-Baseline Medication Flag
psy_medIntegerRecommendedFlag for Psychotropic medication
any_psyIntegerRecommendedAny Psychotropic Con Med at Baseline0;10=No, 1=Yes
anyppsyIntegerRecommendedAny Psychotropic Con Med prior to Baseline
anycpsyIntegerRecommendedAny Psychotropic Con Med ongoing at Baseline
anynpsyIntegerRecommendedAny Psychotropic New in P1 Med at baseline
anypsychIntegerRecommendedAny Conventional Antipsychotic at baseline
anyppsycIntegerRecommendedAny Prior Conv Antipsy at baseline
anycpsycIntegerRecommendedAny Continuous Conv Antipsy at baseline
anynpsycIntegerRecommendedAny New in P1 Conv Antipsy at baseline
anypsyatIntegerRecommendedAny Atypical Antipsychotic at Baseline
anyppsyaIntegerRecommendedAny Prior Atypical Antipsychotic at baseline
anycpsyaIntegerRecommendedAny Cont Atypical Antipsychotic at baseline
anynpsyaIntegerRecommendedAny New in P1 Atypical Antipsychotic at baseline
antipsyIntegerRecommendedTaking antipsychotic medication at baseline1::3
anticholIntegerRecommendedTaking anticholinergic meds at baseline
statinIntegerRecommendedStatin Use at Baseline
oth_cholIntegerRecommendedOther Chol and Trig Reducer Use at baseline
inc_litIntegerRecommendedPatient took at least one LITHIUM at baseline
incc_litIntegerRecommendedIncidence flag for patient continuously
incn_litIntegerRecommendedPatient newly took in P1 at least 1 LITHIUM
n_medIntegerRecommendedNumber of medication taking at baseline
n_pmedIntegerRecommendedNumber of med previously taking at baseline
n_cmedIntegerRecommendedNumber of med continuously taking at baseline
n_nmedIntegerRecommendedNumber of med newly taken in P1
n_psyIntegerRecommendedNumber of Psychotropic med taking at baseline
n_psypriIntegerRecommendedNumber of Psychotropic med previously taking at baseline
n_psyconIntegerRecommendedNumber of Psychotropic meds continuosly taking at baseline
n_psynewIntegerRecommendedNumber of New in P1 Psychotropic meds since baseline
daysrzIntegerRecommendeddays since randomizationdate, exprrz, studyday, visitdt
medcur5String50Recommendedcurrent medication 5med5
medication_5_nameString50Recommendedspecify med 5medsp5
medication5_dosageString50RecommendedFifth medication dosagemdose5
route5String50Recommendedroute 5
med5rzIntegerRecommendedmed 5 start days since randomization
cont5IntegerRecommendeddrug 5 continued0;1;-70=No (discontinued); 1=Yes; -7=Refused
med5drzIntegerRecommendedmed 5 discont days since randomization
medcur6String50Recommendedcurrent medication 6med6
medication_6_nameString50Recommendedspecify med 6medsp6
medication6_dosageString50RecommendedSixth medication dosagemdose6
route6String50Recommendedroute 6
med6rzIntegerRecommendedmed 6 start days since randomization
cont6IntegerRecommendeddrug 6 continued0;1;-70=No (discontinued); 1=Yes; -7=Refused
med6drzIntegerRecommendedmed 6 discont days since randomization
medcur7String50Recommendedcurrent medication 7med7
medication_7_nameString50Recommendedspecify med 7medsp7
medication7_dosageString50RecommendedSeventh medication dosagemdose7
route7String50Recommendedroute 7
med7rzIntegerRecommendedmed 7 start days since randomization
cont7IntegerRecommendeddrug 7 continued0;1;-70=No (discontinued); 1=Yes; -7=Refusedaetrtnum
med7drzIntegerRecommendedmed 7 discont days since randomization
medcur8String50Recommendedcurrent medication 8med8
medication_8_nameString50Recommendedspecify med 8medsp8
medication8_dosageString50RecommendedEighth medication dosagemdose8
route8String50Recommendedroute 8
med8rzIntegerRecommendedmed 8 start days since randomization
cont8IntegerRecommendeddrug 8 continued0;1;-70=No (discontinued); 1=Yes; -7=Refused
med8drzIntegerRecommendedmed 8 discont days since randomization
medcur9String50Recommendedcurrent medication 9med9
medication_9_nameString50Recommendedspecify med 9medsp9
medication9_dosageString50RecommendedNinth medication dosagemdose9
route9String50Recommendedroute 9
med9rzIntegerRecommendedmed 9 start days since randomization
cont9IntegerRecommendeddrug 9 continued0;1;-70=No (discontinued); 1=Yes; -7=Refused
med9drzIntegerRecommendedmed 9 discont days since randomization
medcur10String50Recommendedcurrent medication 10med10
medication_10_nameString50Recommendedspecify med 10medsp10
medication10_dosageString50RecommendedTenth medication dosagemdose10
route10String50Recommendedroute 10
med10rzIntegerRecommendedmed 10 start days since randomization
cont10IntegerRecommendeddrug 10 continued0;1;-70=No (discontinued); 1=Yes; -7=Refused
med10drzIntegerRecommendedmed 10 discont days since randomization
medcur11String50Recommendedcurrent medication 11med11
medication_11_nameString250RecommendedCurrent medication 11medsp11
medication11_dosageFloatRecommendedmedication 11 dosagemdose11
route11String50Recommendedroute 11
med11rzIntegerRecommendedmed 11 start days since randomization
cont11IntegerRecommendeddrug 11 continued0;1;-70=No (discontinued); 1=Yes; -7=Refused
med11drzIntegerRecommendedmed 11 discont days since randomization
medcur12String50Recommendedcurrent medication 12med12
medication_12_nameString50Recommendedspecify med 12medsp12
medication12_dosageFloatRecommendedmedication 12 dosagemdose12
route12String50Recommendedroute 12
med12rzIntegerRecommendedmed 12 start days since randomization
cont12IntegerRecommendeddrug 12 continued0;1;-70=No (discontinued); 1=Yes; -7=Refused
med12drzIntegerRecommendedmed 5 discont days since randomization
siteString100RecommendedSiteStudy Sitecntr_site_x, site_no, site_uid, siteid
visitString50RecommendedVisit nameCharacter description of each type of visitcntr_interval, int1, interval, timept, visit_name
dsmversString10Recommendedversion/name of assessmentform_name
date_updatedDateRecommendedDate record updatededit_date
session_idString20Recommendedsession ID/screening IDscreeningid
completedIntegerRecommendedChecks if form is completed0::20=No; 1=Yes; 2=Yes, lostcntr_frmcomp, formcomp, frmcomp, tststfld
conmednoIntegerRecommendedCheck if NO concomitant medications were used0;10=No; 1=Yescntr_nomeds, meds01, nomeds
medication_nameString255RecommendedName of medicationcmd002, cmname, cntr_meds, desc, drug, drug_d, gdrug, med, meds
ddoseString50Recommendeddaily dose-9=unknowncmd006, cmdose, cntr_dose, cntr_units, dosage, dose, dose_d
1::29; 99
1 = micrograms (mkg); 2 = milligrams (mg); 3 = grams (g); 4 = tablet(s); 5 = capsule(s); 6 = gtt; 7 = meq; 8 = international units (IU); 9 = units (U); 10=Percent (%); 11=Compount/more than one medicine combind; 12=Grains (gr); 13=mg/kg; 99 = Other (specify); 14 = ml; 15 = mg/mL; 16 = mcg/mL; 17 = tbls; 18 = 3tts; 19 = cc; 20 = ss; 21 = puff; 22 = spray/squirt; 23 = suppository; 24 = teaspoon; 25 = uL; 26 = unknown; 27 = oz;28=millicurie; 29=microcuriecmd007, units
cmunitoString50RecommendedUnit other specifycmd007a, cmunitn, cmunitsp, unit, unit_d
1 = oral; 2 = intravenous; 3 = subcutaneous; 4 = topical; 5 = inhalation; 6 = transdermal; 7 = rectal; 8 = intramuscular; 9 = sublingual; 10 = PEG; 99 = Other (specify); 999 =unknown; 11=oral/intramuscular; 12 = Nasal; 13 = Vaginal; 14 = Auricular; 15 = Intra-articular; 16 = Intraocularcmd005, cntr_route, route
cmroutoString30RecommendedRoute other specifycmd005a, cmrte, cmrtspec
1 = QD; 2 = BID; 3 = TID; 4 = QID; 5 = QHS; 6 = CONT IV; 7 = PRN; 8=Q4H; 9=Q6H; 10=Q8H; 11=Q12H; 12=BIS; 13=QS; 14=QM; 15=U; 99 = Other (specify); 16=QOD; 17=qam; 18=qw; 19=q30m; 20=q1h; 21=q5h; 22=biw; 23=qpm; 24=q15m; 25=q3h; 26 = q6pm; 27=tiw; 28 = ac; 29 = q2h;30=once; 31=Unknowncmd008, cntr_freq, freq
cmfreqoString40RecommendedFrequency other specifycmd008a, cmfreqn, cmfrqspe
cmindString75RecommendedIndicationcmd003, cntr_indicate, cntr_purpose, indicate
cmstrtdtDateRecommendedStart Datecmd009, cmedstdt
cmcontIntegerRecommendedContinuing at end of study?1;21=Yes; 2=Nocmcontn, cntr_contmed
cmstpdtDateRecommendedStop Datecmd011, cmedspdt
cmaeIntegerRecommendedWas this for treatment of an AE1;2; -91=Yes; 2=No; -9=Unknowncmd004, cmtae
cmaeidString20RecommendedIf Yes, Specify Adverse Event (Use AE Identifier)-9=Unknowncmd004a
cmf_allergyIntegerRecommendedAllergy/asthma medication1::31=no medication; 2=taken less than 50% of the weeks in the study; 3=taken 50% or more of weeks in the study
cmf_sleepIntegerRecommendedSleep medication1::31=no medication; 2=taken less than 50% of the weeks in the study; 3=taken 50% or more of weeks in the study
cmf_vitaminIntegerRecommendedVitamins1::31=no medication; 2=taken less than 50% of the weeks in the study; 3=taken 50% or more of weeks in the study
cmf_giIntegerRecommendedGI medication1::31=no medication; 2=taken less than 50% of the weeks in the study; 3=taken 50% or more of weeks in the study
cmf_bcIntegerRecommendedBirth control1::31=no medication; 2=taken less than 50% of the weeks in the study; 3=taken 50% or more of weeks in the study
cmf_enuresisIntegerRecommendedEnuresis medication1::31=no medication; 2=taken less than 50% of the weeks in the study; 3=taken 50% or more of weeks in the study
cmf_corticosteroidIntegerRecommendedCorticosteroid medication1::31=no medication; 2=taken less than 50% of the weeks in the study; 3=taken 50% or more of weeks in the study
cmd001IntegerRecommendedMedication number-9=Unknown
cmd010IntegerRecommendedContinuing? (If No, complete Q11. If Yes, end questionnaire.)0;1; -90=No; 1=Yes; -9=Unknowncontmed
cmd24001String50RecommendedLast 24 hours: Medication name (use generic name)
cmd24002String150RecommendedLast 24 hours: Purpose/indicationpurpose
cmd24003FloatRecommendedLast 24 hours: Strength/Dosage
cmd24004IntegerRecommendedLast 24 hours: Units1::71=Capsule/tablet; 2=Milligram; 3=Gram; 4=Cubic cm/mL; 5=Grains; 6=Ounce; 7=Other (specify below);
cmd24004aString30RecommendedLast 24 hours: If "Other", specify units
cmd24005DateRecommendedLast 24 hours: When was the medication taken? (mm/dd/yyyy)
cmd24006String20RecommendedLast 24 hours: What time was the last medication taken? (hh:mm, 24-hour clock; enter 55:55 if unknown)
studyString100RecommendedStudycntr_studyid, studyid
subtrial_nameIntegerRecommendedName of subtrial1::31=Crossover; 2=Guanfacine; 3= Open Label MPH
aef001IntegerRecommendedAdverse Event number1::99; -9-9=unknowncmaenum, ctaenum
pmtotIntegerRecommendedTotal pagescmtot
cmanyIntegerRecommendedDid subject receive any medication0;10=No; 1=Yes
pmmednumIntegerRecommendedMedication/treatment numbermednum
pmstdtIntegerRecommendedDate medication/treatment began in days from the randomization datecmstdt, dateadd, daystart, daystart_d
pmstopIntegerRecommendedDate medication/treatment stopped in days from the randomization datecmstop, datedisc, dayend, dayend_d
meds05aIntegerRecommendedUnknown1;01=Yes; 0=No
1=Yes; 0=Nocmedongo
anyopsycIntegerRecommendedAny Conventional Antipsych in OC Phase11=Yes; missing=otherwise
anycholIntegerRecommendedAny Cholinesterase Inhibitor at Baseline11=Yes; missing=otherwise; indicated med taken at baseline or within 14 days prior to baseline
anyncholIntegerRecommendedAny New Cholinest Inhibitor Since Baseline11=Yes; missing=otherwise; medication added post-baseline
anydpapIntegerRecommendedAny Antidepressant or Antipsych at BL11=Yes; missing=otherwise; indicated med taken at baseline or within 14 days prior to baseline
anyndpapIntegerRecommendedAny New Antidepressant or Antipsych Since BL11=Yes; missing=otherwise; medication added post-baseline
anyhyperIntegerRecommendedAny Anti-Hypertensive Medications at BL11=Yes; missing=otherwise; indicated med taken at baseline or within 14 days prior to baseline
anynhypeIntegerRecommendedAny New Anti- Hypertensive Med Since BL11=Yes; missing=otherwise; medication added post-baseline
anygastrIntegerRecommendedAny Gastrointestinal Medication at BL11=Yes; missing=otherwise; indicated med taken at baseline or within 14 days prior to baseline
anyngastIntegerRecommendedAny New Gastrointestinal Med at BL11=Yes; missing=otherwise; medication added post-baseline
anyopsyIntegerRecommendedAny Psychotropic Med in OC Phase11=Yes; missing=otherwise
n_omedIntegerRecommended# of med taken per patient in OC PhaseNumber of medications taken
n_psyocIntegerRecommendedNumber of Psychotropic meds taken in OCNumber of medications taken
b1_dayIntegerRecommendedBaseline Day - Phase 1/1ANumber of days from study baseline to first day of the phase Based on visit dates
boc_dayIntegerRecommendedBaseline Visit Day- Open Choice PhaseNumber of days from study baseline to start date of phase
es_dayIntegerRecommendedDay Discontinued from StudyNumber of days from study baseline to date of study discontinuation (excluding follow-up phase) Based on visit dates
visitidIntegerRecommendedMetaTrial Visit IDSystem variable: unique code for each type of visit -use to merge files
visitnumIntegerRecommendedVisit number
ocflagIntegerRecommendedMedication Taken During OC Phase Flag0;10=No; 1=Yes
anyopsyaIntegerRecommendedMedication Taken During OC Phase Flag0;10=No; 1=Yes
visdayIntegerRecommendedNumber of days from study baseline to date of visitcntr_visitdat_x, daycml, dayctl_d
pageIntegerRecommendedPage of formpage_d
slotIntegerRecommendedSlot on Concomitant Medication Log formslot_d
compoundString100RecommendedGeneric name of compoundcompound_d
extraString100RecommendedAdditional compounds in Concomitant Medicationextra_d
drugcontIntegerRecommendedIs Concomitant Medication still being used?0;10 = No;1 = Yescont, cont_d
medconString100RecommendedMedical Condition for which Concomitant Medication was takeninteger, medcon_d
daysIntegerRecommendedNumber of Days at Current Dose0::9999
med_sequenceIntegerRecommendedMed Sequence number
weekFloatRecommendedWeek in level/study99=week 10-week 14intid, week1
vis_typeIntegerRecommendedVisit type0::21=Phone; 0=doctor's office; 2=No, not phone interviewphone
cntr_othrtrtIntegerRecommendedReceived any treatments other than medic1;21=Yes;2=Noothrtrt
cntr_conttrtIntegerRecommendedContinue Other Treatment1;21=Yes;2=Noconttrt
cntr_adddat_xIntegerRecommendedDay Medication Added
treatment_nameString200Recommendedtreatment namecntr_treatmnt, treatmnt
med1drzIntegerRecommendedmed 1 discontinued days since randomizationcntr_discdat_x
trtgroupString2RecommendedTreatment GroupN1;N2;R1;R2;R3N1=Non-Responder Entering Fluvoxamine; N2=Non-Responder Entering Fluoxetine; R1=Maintenance; R2=Responder Entering Fluvoxamine; R3=Responder Entering Fluoxetine
study_idIntegerRecommendedStudy ID number46=Acute Phase; 47=Stabilization Phase
hi_31a5IntegerRecommendedMedication 1 days from baseline startedstartdays
hi_31a6IntegerRecommendedMedication 1 days from baseline stoppedstopdays
ci_enrolledIntegerRecommendedParticipant enrolled0;10=No; 1=Yes
commentsString4,000RecommendedComments about assessmentefirstlan
linenoIntegerRecommendedLine number (lines per participant)0::150
aescodeIntegerRecommendedStaff code number of person completing this form
medication1_weeksFloatRecommendedTotal weeks of medication 1
days_baselineIntegerRecommendedDays since baseline
visnumFloatRecommendedNumeric Visit Number-1.5 = Pre-Screening; -1 = Screening; 0 = Baseline; ## = Visit ## (from 1 to 10); Whole numbers = standard monthly visits; #.001 - #.009 = Unscheduled; #.1 = End of Phase 1; #.2 = End of Phase 2; #.3 = End of Phase 3; #.4 = End of Open Choice Phase; #.5 = End of Study; #.6 = Genetic Analysis; 1000=all visits
me2IntegerRecommendedStatus0;10 = Past [Inactive]; 1 = Active
anymedsIntegerRecommendedHas the subject taken any medications 30 days/1 month prior to or during this study OR taken any antipsychotics at any time?0;10 = No; 1 = Yes
adhgen1String50RecommendedGeneric name of medication name provided
med_classString50RecommendedMedication class for the prescription
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
  • For valid elements with shared data, on the far left is a Filter button you can use to view a summary of shared data for that element and apply a query filter to your Cart based on selected value ranges

At the top of this page you can also:

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  • Download a copy of this definition in CSV format
  • Download a blank CSV submission template prepopulated with the correct structure header rows ready to fill with subject records and upload

Please email the The NDA Help Desk with any questions.

Distribution for DataStructure: med01 and Element:
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