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Description
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Data Structures with shared data
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End of Treatment Form

etf

01

Clinical Trials: End of Treatment Form

Download Definition as
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Element NameData TypeSizeRequiredDescriptionValue RangeNotesAliases
subjectkeyGUIDRequiredThe NDAR Global Unique Identifier (GUID) for research subjectNDAR*
src_subject_idString20RequiredSubject ID how it's defined in lab/projectSUBJECT, bid, stepid
interview_dateDateRequiredDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYYRequired fieldETFDate
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.dema1
genderString20RequiredSex of the subjectM;FM = Male; F = Femaledema2
aescodeIntegerRecommendedStaff code number of person completing this formETFCODE
visitString50RecommendedVisit nameCharacter description of each type of visit
bafinfoIntegerRecommendedCheck if the Assessment was not done.0;10=No; 1=YesETFINFO
etfrsnIntegerRecommendedReason for End of Treatment Form1;21=Patient completed 40 hours of study treatment; 2=Patient did not complete 40 hours of study treatment, but has reached 12 weeks since randomization
tcdateDateRecommendedDate of study treatment completion
erlrsnString1RecommendedPatient ended study early for which reasonA;B;C;D; E; FA= Withdrew consent; B=Medical reason; C= Non-compliance with protocol or treatment; D=Terminatin of study by sponsor; E= Subject terminated at discretion of the investigator or sponsor; F= Other
erlrsmdsString255RecommendedDescribe reason for early terminationrtd
daysrzIntegerRecommendeddays since randomizationexitrz
certcodeIntegerRecommendedstepbd certification code
exitreasIntegerRecommendedomega3 exit reason1::161=Completion of 52 week protocol; 2=Consent withdrawn; 3=Recurrence of mania; 4=Recurrence of hypomania; 5=Recurrence of depression; 6=Recurrence of mixed episode; 7=Emerging or worsening of subsyndromal mood or neurovegetative symptoms; 8=Intolerable adverse effects; 9=Significant non compliance with protocol; 10=Emergence of significant suicidal ideation; 11=Emergence of significant homicidal ideation; 12=Medical or surgical conditions; 13=Suicide; 14=Homicide; 15=Death (all other causes); 16=Other
unmaskedIntegerRecommendedrandomization unmasking0;1;-70=No; 1=Yes; -7=Refused
siteString100RecommendedSiteStudy Sitesite_id, siteid
deprexitIntegerRecommendeddepression rand care path exit0::80=Treatment responder; 1=Nonresponder 1; 2=Nonresponder 2; 3=Nonresponder 3; 4=Nonresponder 4; 5=Significant non compliance with study protocol; 6=Ineligible; 7=Other; 8=Clinically contra indicated to continue tx
ncmedIntegerRecommendedNC: has GMC contra level 1 or 2 tx0;10=Not checked; 1=Checked
nctxIntegerRecommendednoncompliance psych treatment0;1;-70=No; 1=Yes;-7=Refused
ncevalIntegerRecommendednoncompliance evaluations0;1;-70=No; 1=Yes;-7=Refused
ncdoseIntegerRecommendednoncompliance incorrect dose0;1;-70=No; 1=Yes;-7=Refused
ncothIntegerRecommendedNC: other reason0;10=Not checked; 1=Checked
rtda1IntegerRecommendedWhat date was the assigned study treatment stopped?0::999timest
rtda2IntegerRecommendedDid patient successfully complete the protocol on the assigned treatment?0;11=Yes; 0=No
rtda3IntegerRecommendedWas study treatment discontinued for administrative reasons?0;11=Yes; 0=No;Note: This implies that both the patient and the clinical staff judge the assigned antipsychotic treatment to be a success (i.e. adequately effective, with tolerable or no side effects), and that treatment would have continued if not for the administrative reason independent of the study procedures.
rtda4IntegerRecommendedWas study treatment discontinued based on a clinical decision of inadequate therapeutic effect0;11=Yes; 0=No
rtda5IntegerRecommendedWhat was the problematic psychopathology?1;2;31=Postitive Psychopathology; 2=Negative Psychopathology; 3=Affective Psychopathology
rtda6IntegerRecommendedWas study treatment discontinued based on a clinical decision of unacceptable side effects?0;11=Yes; 0=No
rtda7IntegerRecommendedIndicate the most problematic side effect1;2;3;4;5;6;7;8;9;10;111=Weight Gain; 2=Lipids; 3=Glucose; 4=EPS; 5=TD; 6=Akathisia/activation; 7=Sexual Dysfunction; 8=Breast changes/galactorrhea; 9=Menstrual irregularities; 10=Hypersensitivity during oral antipsychotic trial; 11=other
rtda8IntegerRecommendedWas study treatment discontinued based on patient decision, refusal/failure to take the assigned antipsychotic?0;11=Yes; 0=No;Note: This implies that clinical staff believes the patient should continue on the assigned LAI antipsychotic, but the patient, through words and/or actions, refuses to do so.
rtda9IntegerRecommendedIndicate patients reason for study medication discontinuation:1;2;3;4;51=Patient lost to follow-up, no information available; 2=Patient believes he/she does not need any antipsychotic medication; 3=Patient willing to take antipsychotic medication, but not the assigned LAI antipsychotic medication; 4=Patient no longer willing to do study procedures such as blood draws or ratings; 5= Other
version_formString100RecommendedForm usedvers
visdayIntegerRecommendedNumber of days from study baseline to date of visit
fseqnoIntegerRecommendedSequence Number0::999The FSEQNO variable in the ADJ form has a special interpretation compared to other forms. For example, ADJ FSEQNO of '1' can be thought of as being '001', FSEQNO of '2' can be thought of as being '002', and FSEQNO of '3' can be thought of as being '003'. The first digit of FSEQNO relates to the corresponding ENF sequence number at that visit and the third digit relates to the specific adjudicator who completed the adjudication form.
istatusIntegerRecommendedISTATUS: 1 =discontinued trt/protocol early, 0 =otherwise (indicator variable for variable STATUS)0;10=Otherwise; 1=Discontinued treatment/protocol earlytrtdscon
tstdymedIntegerRecommendedTaking Study Meds Up To Time Of Visit0;10=No; 1=Yes
timeallIntegerRecommendedTime To All-Cause Treatment Discontinuation in Days0::365
discont_statusString2RecommendedDetailed status of subject in terms of early discontinuation/violation or completing the studyA=Lack of efficacy; B=Unacceptable side effects; C=Participant refusal; D=Lost to Follow-up; E=Disallowed Med; F=Never took study meds; G=Completer
rtdvisString50RecommendedVisit on when participant had RTDA form
weekFloatRecommendedWeek in level/study99=week 10-week 14
compprotIntegerRecommendedCompleted treatment protocol0;1;-70=No; 1=Yes; -7=Refused
er_who_invIntegerRecommendedinvestigator initiated termination1;01=yes; 0=no
er_who_subIntegerRecommendedsubject initiated termination1;01=yes; 0=no
er_who_famIntegerRecommendedfamily initiated termination1;01=yes; 0=no
pr_protcompIntegerRecommendedPrimary reason for termination: Protocal Complete1;01=yes; 0=no
pr_adminIntegerRecommendedPrimary reason for termination: Administrative1;01=yes; 0=no
pr_cinadeffIntegerRecommendedPrimary reason for termination: Inadequate Theraeutic effect1;01=yes; 0=no
pr_ciaprobString3RecommendedPrimary reason for termination: Problematic PsychopathologyP;N;A;O;NP=positive;N=negative;A=affective;O = other;N = not applicable
pr_ciaprobsString20RecommendedPrimary reason for termination: Problematic Psychopathology SpecifyActual value
pr_csideeffIntegerRecommendedPrimary reason for termination: Unacceptable Side Effects1;01=yes; 0=no
pr_cseepseIntegerRecommendedPrimary reason for termination: Unacceptable Side Effect was EPSE1;01=yes; 0=no
pr_csewtIntegerRecommendedPrimary reason for termination: Unacceptable Side Effect was Weight1;01=yes; 0=no
pr_csesexIntegerRecommendedPrimary reason for termination: Unacceptable Side Effect was Sexual1;01=yes; 0=no
pr_cseinsomIntegerRecommendedPrimary reason for termination: Unacceptable Side Effect was Insomnia1;01=yes; 0=no
pr_csemaniaIntegerRecommendedPrimary reason for termination: Unacceptable Side Effect was Mania1;01=yes; 0=no
pr_cseirritIntegerRecommendedPrimary reason for termination: Unacceptable Side Effect was Irritability1;01=yes; 0=no
pr_cseothIntegerRecommendedPrimary reason for termination: Unacceptable Side Effect was Other1;01=yes; 0=no
pr_cseothsString20RecommendedPrimary reason for termination: Unacceptable Side Effect was Other SpecifyActual value
pr_pnottakeIntegerRecommendedPrimary reason for termination: Noncompliance1;01=yes; 0=no
er_secreasIntegerRecommendedOther Reasons for Terminating1;01=yes; 0=no
sr_adminIntegerRecommendedSecondary reason for termination: Administrative1;01=yes; 0=no
sr_cinadeffIntegerRecommendedSecondary reason for termination: Inadequate Theraeutic effect1;01=yes; 0=no
sr_ciaprobIntegerRecommendedSecondary reason for termination: Problematic Psychopathology1::41=positive;2=negative;3=affective;4 = other
sr_ciaprobsString20RecommendedSecondary reason for termination: Problematic Psychopathology SpecifyActual value
sr_csideeffIntegerRecommendedSecondary reason for termination: Unacceptable Side Effects1;01=yes; 0=no
sr_cseepseIntegerRecommendedSecondary reason for termination: Unacceptable Side Effect was EPSE1;01=yes; 0=no
sr_csewtIntegerRecommendedSecondary reason for termination: Unacceptable Side Effect was Weight1;01=yes; 0=no
sr_csesexIntegerRecommendedSecondary reason for termination: Unacceptable Side Effect was Sexual1;01=yes; 0=no
sr_cseinsomIntegerRecommendedSecondary reason for termination: Unacceptable Side Effect was Insomnia1;01=yes; 0=no
sr_csemaniaIntegerRecommendedSecondary reason for termination: Unacceptable Side Effect was Mania1;01=yes; 0=no
sr_cseirritIntegerRecommendedSecondary reason for termination: Unacceptable Side Effect was Irritability1;01=yes; 0=no
sr_cseothIntegerRecommendedSecondary reason for termination: Unacceptable Side Effect was Other1;01=yes; 0=no
sr_cseothsString20RecommendedSecondary reason for termination: Unacceptable Side Effect was Other Specify
sr_pnottakeIntegerRecommendedSecondary reason for termination: Noncompliance1;01=yes; 0=no
er_conttreatIntegerRecommendedsubject continuing antipsychotic treatment0::30=No; 1=rerandomized; 2=Ziprasidone;3=Community Care
er_guesstrtString3Recommendedbest guess of treatment receivedZ;C;M;R;O;N;MO; MPZ =Ziprasidone; C =Community Care; M =Molindone; R =Risperidone; O =Olanzapine;N=Not Applicable;MO=Medication Only;MP=Medication+PMT
er_certtrtString3Recommendedhow certain of best guessCS;FS;TG;CU;NCS =Completely Sure; FS =Fairly Sure; TG=Tentative Guess; CU=Completely Uncertain; N= Not Applicable
ptleffIntegerRecommendedIs Lack of Efficacy the type of information on which your guess is based0;10 = Not indicated;1 = Yes
ptpeffIntegerRecommendedIs Presence of efficacy the type of information on which your guess is based0;10 = Not indicated;1 = Yes
ptaseIntegerRecommendedIs Absence of side effects the type of information on which your guess is based0;10 = Not indicated;1 = Yes
ptpseIntegerRecommendedIs Presence of side effects the type of information on which your guess is based0;10 = Not indicated;1 = Yes
er_info_naIntegerRecommendedguess basis: Not applicable1;01=yes; 0=no
ptothIntegerRecommendedIs Other Types of Information the type of information on which your guess is based0;10 = Not indicated;1 = Yes
pt3othString60RecommendedIf Other Types of Information the type of information on which your guess is based, explain
sa_any_allwkIntegerRecommendedSuicide attempt reported during any of the study weeks0;1; -888; -9990=No; 1=Yes; -888=Not Applicable; -999=Missing;
er_assaultsIntegerRecommendedassaults on others during study1;01=yes; 0=no
er_arrestsIntegerRecommendedarrests during study1;01=yes; 0=no
er_liveifamIntegerRecommendedcurrent living situation: immediate family1;01=yes; 0=no
er_liveefamIntegerRecommendedcurrent living situation: extended family1;01=yes; 0=no
er_liveghomeIntegerRecommendedcurrent living situation: group home1;01=yes; 0=no
er_liveresIntegerRecommendedcurrent living situation: residential1;01=yes; 0=no
er_livephospIntegerRecommendedcurrent living situation: psychiatric hospital1;01=yes; 0=no
er_livemhossIntegerRecommendedcurrent living situation: mental hospital study complication1;01=yes; 0=no
er_livemhosuIntegerRecommendedcurrent living situation: mental hospital unrelated problem1;01=yes; 0=no
er_livesheltIntegerRecommendedcurrent living situation: shelter1;01=yes; 0=no
er_liveothIntegerRecommendedcurrent living situation: other1;01=yes; 0=no
er_termdxString6Recommendedsubject's diagnosis at termination3-5 digit code (XXX.XX)
er_dxchangeIntegerRecommendeddiagnosis changed from enrollment1;01=yes; 0=no
er_secdxIntegerRecommendedSecondary Diagnosis? (Y or N)1;01=yes; 0=no
encounter1_020String100RecommendedSecondary ICD Diagnosis Code
er_secdx2String6RecommendedSecondary Diagnosis #2XXX.XX
er_secdx3String6RecommendedSecondary Diagnosis #3XXX.XX
er_secdx4String6RecommendedSecondary Diagnosis #4XXX.XX
er_secdx5String6RecommendedSecondary Diagnosis #5XXX.XX
treatString1RecommendedTreatment for RandomizationX;Y;Z
trm_q3IntegerRecommendedDate of study termination in days from the randomization/enrollment date (TRM_Q3 = Date of study termination - randomization/enrollment date)
compdtIntegerRecommendedStudy completion date, since randomizationOffset from randomization
rand_numIntegerRecommendedRandomization Number0::2
comments_miscString4,000RecommendedMiscellaneous comments on study, interview, methodology relevant to this form data
sigp1IntegerRecommendedPhysician signature present0;10 = No; 1 = Yes
sigd1IntegerRecommendedPhysician/PI signature date (days since randomization)
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
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)
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Distribution for DataStructure: etf01 and Element:
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