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End of Treatment Form

901 Shared Subjects

Clinical Trials: End of Treatment Form
Clinical Assessments
Exit Form
06/25/2014
etf01
06/25/2014
View Change History
01
Query Element Name Data Type Size Required Description Value Range Notes Aliases
subjectkey GUID Required The NDAR Global Unique Identifier (GUID) for research subject NDAR*
src_subject_id String 20 Required Subject ID how it's defined in lab/project SUBJECT, bid, stepid
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY ETFDate
interview_age Integer Required Age in months at the time of the interview/test/sampling/imaging. 0 :: 1260 Age 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
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported dema2, gender
Query aescode Integer Recommended Staff code number of person completing this form 999= Missing Data ETFCODE
Query visit String 60 Recommended Visit name
Query bafinfo Integer Recommended Check if the Assessment was not done. 0::2 0=No; 1=Yes; 2=Unverified ETFINFO
Query etfrsn Integer Recommended Reason for End of Treatment Form 1;2 1=Patient completed 40 hours of study treatment; 2=Patient did not complete 40 hours of study treatment, but has reached 12 weeks since randomization
tcdate Date Recommended Date of study treatment completion
Query erlrsn String 1 Recommended Patient ended study early for which reason A;B;C;D; E; F A= 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
Query erlrsmds String 255 Recommended Describe reason for early termination rtd
Query daysrz Integer Recommended days since randomization exitrz
Query certcode Integer Recommended stepbd certification code
Query exitreas Integer Recommended omega3 exit reason 1::16 1=Completion of 52 week protocol; 2=Consent withdrawn; 3=Recurrence of mania; 4=Recurrence of hypomania; 5=Recurrence of depression; 6=Recurrence of mixed episode; 7=Emerging or worsening of subsyndromal mood or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
Query unmasked Integer Recommended randomization unmasking 0;1;-7 0=No; 1=Yes; -7=Refused
Query site String 101 Recommended Site Study Site site_id, siteid
Query deprexit Integer Recommended depression rand care path exit 0::8 0=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
Query ncmed Integer Recommended NC: has GMC contra level 1 or 2 tx 0;1 0=Not checked; 1=Checked
Query nctx Integer Recommended noncompliance psych treatment 0;1;-7 0=No; 1=Yes;-7=Refused
Query nceval Integer Recommended noncompliance evaluations 0;1;-7 0=No; 1=Yes;-7=Refused
Query ncdose Integer Recommended noncompliance incorrect dose 0;1;-7 0=No; 1=Yes;-7=Refused
Query ncoth Integer Recommended NC: other reason 0;1 0=Not checked; 1=Checked
Query rtda1 Integer Recommended What date was the assigned study treatment stopped? 0::999 timest
Query rtda2 Integer Recommended Did patient successfully complete the protocol on the assigned treatment? 0;1 1=Yes; 0=No
Query rtda3 Integer Recommended Was study treatment discontinued for administrative reasons? 0;1 1=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.
Query rtda4 Integer Recommended Was study treatment discontinued based on a clinical decision of inadequate therapeutic effect 0;1 1=Yes; 0=No
Query rtda5 Integer Recommended What was the problematic psychopathology? 1;2;3 1=Postitive Psychopathology; 2=Negative Psychopathology; 3=Affective Psychopathology
Query rtda6 Integer Recommended Was study treatment discontinued based on a clinical decision of unacceptable side effects? 0;1 1=Yes; 0=No
Query rtda7 Integer Recommended Indicate the most problematic side effect 1;2;3;4;5;6;7;8;9;10;11 1=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
Query rtda8 Integer Recommended Was study treatment discontinued based on patient decision, refusal/failure to take the assigned antipsychotic? 0;1 1=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.
Query rtda9 Integer Recommended Indicate patients reason for study medication discontinuation: 1;2;3;4;5 1=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_form String 121 Recommended Form used/assessment name vers
Query visday Integer Recommended Number of days from study baseline to date of visit
Query fseqno Integer Recommended Sequence Number 0::999 The 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.
Query istatus Integer Recommended ISTATUS: 1 =discontinued trt/protocol early, 0 =otherwise (indicator variable for variable STATUS) 0;1 0=Otherwise; 1=Discontinued treatment/protocol early trtdscon
Query tstdymed Integer Recommended Taking Study Meds Up To Time Of Visit 0;1 0=No; 1=Yes
Query timeall Integer Recommended Time To All-Cause Treatment Discontinuation in Days 0::365
Query discont_status String 2 Recommended Detailed status of subject in terms of early discontinuation/violation or completing the study A=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
Query rtdvis String 50 Recommended Visit on when participant had RTDA form
Query week Float Recommended Week in level/study 99=week 10-week 14
Query compprot Integer Recommended Completed treatment protocol 0;1;-7 0=No; 1=Yes; -7=Refused
Query er_who_inv Integer Recommended investigator initiated termination 1;0 1=yes; 0=no
Query er_who_sub Integer Recommended subject initiated termination 1;0 1=yes; 0=no
Query er_who_fam Integer Recommended family initiated termination 1;0 1=yes; 0=no
Query pr_protcomp Integer Recommended Primary reason for termination: Protocal Complete 1;0 1=yes; 0=no
Query pr_admin Integer Recommended Primary reason for termination: Administrative 1;0 1=yes; 0=no
Query pr_cinadeff Integer Recommended Primary reason for termination: Inadequate Theraeutic effect 1;0 1=yes; 0=no
Query pr_ciaprob String 3 Recommended Primary reason for termination: Problematic Psychopathology P;N;A;O;N P=positive;N=negative;A=affective;O = other;N = not applicable
Query pr_ciaprobs String 20 Recommended Primary reason for termination: Problematic Psychopathology Specify Actual value
Query pr_csideeff Integer Recommended Primary reason for termination: Unacceptable Side Effects 1;0 1=yes; 0=no
Query pr_cseepse Integer Recommended Primary reason for termination: Unacceptable Side Effect was EPSE 1;0 1=yes; 0=no
Query pr_csewt Integer Recommended Primary reason for termination: Unacceptable Side Effect was Weight 1;0 1=yes; 0=no
Query pr_csesex Integer Recommended Primary reason for termination: Unacceptable Side Effect was Sexual 1;0 1=yes; 0=no
Query pr_cseinsom Integer Recommended Primary reason for termination: Unacceptable Side Effect was Insomnia 1;0 1=yes; 0=no
Query pr_csemania Integer Recommended Primary reason for termination: Unacceptable Side Effect was Mania 1;0 1=yes; 0=no
Query pr_cseirrit Integer Recommended Primary reason for termination: Unacceptable Side Effect was Irritability 1;0 1=yes; 0=no
Query pr_cseoth Integer Recommended Primary reason for termination: Unacceptable Side Effect was Other 1;0 1=yes; 0=no
Query pr_cseoths String 20 Recommended Primary reason for termination: Unacceptable Side Effect was Other Specify Actual value
Query pr_pnottake Integer Recommended Primary reason for termination: Noncompliance 1;0 1=yes; 0=no
Query er_secreas Integer Recommended Other Reasons for Terminating 1;0 1=yes; 0=no
Query sr_admin Integer Recommended Secondary reason for termination: Administrative 1;0 1=yes; 0=no
Query sr_cinadeff Integer Recommended Secondary reason for termination: Inadequate Theraeutic effect 1;0 1=yes; 0=no
Query sr_ciaprob Integer Recommended Secondary reason for termination: Problematic Psychopathology 1::4 1=positive;2=negative;3=affective;4 = other
Query sr_ciaprobs String 20 Recommended Secondary reason for termination: Problematic Psychopathology Specify Actual value
Query sr_csideeff Integer Recommended Secondary reason for termination: Unacceptable Side Effects 1;0 1=yes; 0=no
Query sr_cseepse Integer Recommended Secondary reason for termination: Unacceptable Side Effect was EPSE 1;0 1=yes; 0=no
Query sr_csewt Integer Recommended Secondary reason for termination: Unacceptable Side Effect was Weight 1;0 1=yes; 0=no
Query sr_csesex Integer Recommended Secondary reason for termination: Unacceptable Side Effect was Sexual 1;0 1=yes; 0=no
Query sr_cseinsom Integer Recommended Secondary reason for termination: Unacceptable Side Effect was Insomnia 1;0 1=yes; 0=no
Query sr_csemania Integer Recommended Secondary reason for termination: Unacceptable Side Effect was Mania 1;0 1=yes; 0=no
Query sr_cseirrit Integer Recommended Secondary reason for termination: Unacceptable Side Effect was Irritability 1;0 1=yes; 0=no
Query sr_cseoth Integer Recommended Secondary reason for termination: Unacceptable Side Effect was Other 1;0 1=yes; 0=no
Query sr_cseoths String 20 Recommended Secondary reason for termination: Unacceptable Side Effect was Other Specify
Query sr_pnottake Integer Recommended Secondary reason for termination: Noncompliance 1;0 1=yes; 0=no
Query er_conttreat Integer Recommended subject continuing antipsychotic treatment 0::3 0=No; 1=rerandomized; 2=Ziprasidone;3=Community Care
Query er_guesstrt String 3 Recommended best guess of treatment received Z;C;M;R;O;N;MO; MP Z =Ziprasidone; C =Community Care; M =Molindone; R =Risperidone; O =Olanzapine;N=Not Applicable;MO=Medication Only;MP=Medication+PMT
Query er_certtrt String 3 Recommended how certain of best guess CS;FS;TG;CU;N CS =Completely Sure; FS =Fairly Sure; TG=Tentative Guess; CU=Completely Uncertain; N= Not Applicable
Query ptleff Integer Recommended Is Lack of Efficacy the type of information on which your guess is based 0;1 0 = Not indicated;1 = Yes
Query ptpeff Integer Recommended Is Presence of efficacy the type of information on which your guess is based 0;1 0 = Not indicated;1 = Yes
Query ptase Integer Recommended Is Absence of side effects the type of information on which your guess is based 0;1 0 = Not indicated;1 = Yes
Query ptpse Integer Recommended Is Presence of side effects the type of information on which your guess is based 0;1 0 = Not indicated;1 = Yes
Query er_info_na Integer Recommended guess basis: Not applicable 1;0 1=yes; 0=no
Query ptoth Integer Recommended Is Other Types of Information the type of information on which your guess is based 0;1 0 = Not indicated;1 = Yes
Query pt3oth String 60 Recommended If Other Types of Information the type of information on which your guess is based, explain
Query sa_any_allwk Integer Recommended Suicide attempt reported during any of the study weeks 0;1; -888; -999 0=No; 1=Yes; -888=Not Applicable; -999=Missing;
Query er_assaults Integer Recommended assaults on others during study 1;0 1=yes; 0=no
Query er_arrests Integer Recommended arrests during study 1;0 1=yes; 0=no
Query er_liveifam Integer Recommended current living situation: immediate family 1;0 1=yes; 0=no
Query er_liveefam Integer Recommended current living situation: extended family 1;0 1=yes; 0=no
Query er_liveghome Integer Recommended current living situation: group home 1;0 1=yes; 0=no
Query er_liveres Integer Recommended current living situation: residential 1;0 1=yes; 0=no
Query er_livephosp Integer Recommended current living situation: psychiatric hospital 1;0 1=yes; 0=no
Query er_livemhoss Integer Recommended current living situation: mental hospital study complication 1;0 1=yes; 0=no
Query er_livemhosu Integer Recommended current living situation: mental hospital unrelated problem 1;0 1=yes; 0=no
Query er_liveshelt Integer Recommended current living situation: shelter 1;0 1=yes; 0=no
Query er_liveoth Integer Recommended current living situation: other 1;0 1=yes; 0=no
Query er_termdx String 6 Recommended subject's diagnosis at termination 3-5 digit code (XXX.XX)
Query er_dxchange Integer Recommended diagnosis changed from enrollment 1;0 1=yes; 0=no
Query er_secdx Integer Recommended Secondary Diagnosis? (Y or N) 1;0 1=yes; 0=no
Query encounter1_020 String 100 Recommended Secondary ICD Diagnosis Code
Query er_secdx2 String 6 Recommended Secondary Diagnosis #2 XXX.XX
Query er_secdx3 String 6 Recommended Secondary Diagnosis #3 XXX.XX
er_secdx4 String 6 Recommended Secondary Diagnosis #4 XXX.XX
er_secdx5 String 6 Recommended Secondary Diagnosis #5 XXX.XX
Query treat String 1 Recommended Treatment for Randomization X;Y;Z
Query trm_q3 Integer Recommended Date of study termination in days from the randomization/enrollment date (TRM_Q3 = Date of study termination - randomization/enrollment date)
Query compdt Integer Recommended Study completion date, since randomization Offset from randomization
Query rand_num Integer Recommended Randomization Number 0::2
comments_misc String 4,000 Recommended Miscellaneous comments on study, interview, methodology relevant to this form data
Query sigp1 Integer Recommended Physician signature present 0;1 0 = No; 1 = Yes
Query sigd1 Integer Recommended Physician/PI signature date (days since randomization)
Query visnum Float Recommended Numeric 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:

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  • Description: A basic description
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  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
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