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Discontinuation Form

534 Shared Subjects

N/A
Clinical Assessments
Exit Form
03/24/2015
discont01
01/09/2020
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 bid, case_id
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY
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. bslage
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
Query site String 101 Recommended Site Study Site site_no
Query trt_grp String 10 Recommended Treatment Group Assignment 1;1AO;1CT;2; 3;4;5;6;7;8;9;10;11;12; O; P; CCA; GCT; TCT; TAU; CGC; ESDM; NA 1=Group 1 first 8 weeks; 2=Group 2; 3=Group 3; 4 =active; 5=sham; 6=none; 7=ESDM High intensity; 8=ESDM Low intensity; 9=EIBI High intensity; 10=EIBI Low intensity; ESDM = Early Start Denver Model; EIBI = Early and Intensive Behavioral Intervention; 11 = Navigator; 12 = Care manager; 13=Waitlist Control; 14=Treatment; 1AO=Group 1 8 week add on; 1CT=Group 1 8 week cross taper; O=Oxytocin; P=Placebo; CCA=Community Control Arm; GCT=Generalized Cognitive Training; TCT=Targeted Cognitive Training; TAU=Treatment as Usual; CGC = Computer Games Control; NA=not assigned to treatment group
Query days_baseline Integer Recommended Days since baseline bsldays
Query etype String 10 Recommended Rating Period BSL;WK1;WK2;WK3;WK4;WK5;WK6;WK7;WK8;WK9;WK10;WK11;WK12;WK13;WK14;WK15;WK16 BSL=Baseline; WK1-WK16=Weeks 1-16
Query respond_detail_oth_spec String 255 Recommended Respondent details informnt
Query relationship Integer Recommended Relationship of respondent to individual
1::94;-999
1 = Biological mom; 2 = Biological dad; 3 = Grandparent; 4 = Special education (sped) teacher; 5 = General education teacher; 6 = Occupational therapist; 7 = Speech and language therapist; 8 = Behavioral therapist; 9 = Paraprofessional; 10 = Aide; 11 = Principal; 12 = Administrator; 14 = Content teacher; 15 = Parent center director; 16 = Self; 17=Adoptive mother; 18=Adoptive father; 19=Foster mother; 20 = Foster father; 21=Grandmother; 22=Grandfather; 23=Step-mother; 24 = Step-father; 25=Aunt; 26=Uncle; 28=Both parents;31= Grandmother from mother side; 32= Grandfather from mother side; 33= Grandmother from father side; 34= Grandfather from father side; 36= Brother; 37= Sister; 38= Cousin; 39= female caregiver; 40=male caregiver; 41=Female child; 42=Male child; 43=Spouse/Mate; 44=Friend; 45=Parent; 46=Significant other; 47=Sibling; 48=Son/Daughter; 49=Son-in-law/Daughter-in law; 50=Other Relative; 51=Paid caregiver; 52=Friends; 53=Roommate; 54=Supervisor; 55=mother's boyfriend; 56=other parental figure; 57=Summary; 58=counselor ; 59 = other female relative; 60 = other male relative; 61 = non-relative ; 62=Maternal Aunt; 63=Maternal Uncle; 64=Maternal Cousin; 65 = Paternal Aunt; 66=Paternal Uncle; 67=Paternal Cousin ; 68=Biological/Adoptive Mother and Grandmother; 69=Biological/Adoptive Mother and Stepmother and Grandmother; 70=Biological/Adoptive Mother and Grandmother and Foster Father; 71=Biological/Adoptive Mother and Stepmother and Foster Mother; 72=Biological/Adoptive Mother and Foster Mother; 73=Biological/Adoptive Mother and Biological/Adoptive Father; 74=Biological/Adoptive Mother and Stepmother and Biological/Adoptive Father; 75=Biological/Adoptive Mother and Other; 76=Biological/Adoptive Mother and Stepmother and Stepfather; 77=Biological/Adoptive Mother and Stepfather; 78=Biological/Adoptive Mother and Grandfather; 79=Biological/Adoptive Mother and Stepmother and Foster Father; 80=Biological/Adoptive Mother and Stepmother; 81=Guardian, female; 82=Other female; 83=Guardian, male; 84=Other male; 85=Other/Grandparent/Nanny; 86 = Mother, Father, Guardian; 87 = Daughter, son, grandchild; 88 = Professional (e.g., social worker, nurse, therapist, psychiatrist, or group home staff); -999=Missing; 89 = Biological parent; 90=Other; 91 = Stepparent; 92 = Adoptive parent; 93 = Foster parent; 94 = Co-worker infrmnt2
Query dfrsn Integer Recommended Reason for discontinuation 1::7 1=Hospitalization; 2=Pregnancy; 3=Onset of severe illness; 4=Worsening of symptoms; 5=Use of more than 10 doses of Chlorpromazine; 6=Weight/BMI increase; 7=Other
Query df_reason String 10 Recommended Reason for discontinuation recorded HOSP;PREG;ILL;WORS;CHLR;WGT;CHNG;SIDE;GEOG;OTHR HOSP=Hospitalization; PREG=Pregnancy; ILL=Onset of severe illness; WORS=Worsening of symptoms; CHLR=Use of more than 10 doses of Chlorpromazine; WGT=Weight/BMI increase; CHNG=Changed mind; GEOG=Geographical relocation; OTHR=Other
Query df_commnt String 250 Recommended If other-provide details
Query rtda1 Integer Recommended What date was the assigned study treatment stopped? 0::999 rtda2_1
Query rtda2 Integer Recommended Did patient successfully complete the protocol on the assigned treatment? 0;1 1=Yes; 0=No rtda1_1
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 visit String 60 Recommended Visit name
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.
version_form String 121 Recommended Form used/assessment name vers
Query daysrz Integer Recommended days since randomization rtda0b
Query rtda1a Integer Recommended Did patient complete 24 weeks on the assigned anti-psychotic? (Y/N) 0;1 0=No; 1=Yes
Query rtda2a Integer Recommended What date was the study anti-psychotic stopped? [days since randomization] 0::365
Query rtda3a Integer Recommended What was the reason the study anti-psychotic was stopped? (choose the primary reason) A. Efficacy/Inadequate therapeutic effect: Positive symptoms, negative symptoms, mood symptoms, other. B. Unacceptable side effects: Weight, lipids, glucose, EPS, TD, akathisia/activation, sedation, insomnia, agitation, sexual side effects, nausea, other. C. Patient refusal : Does not see need for or benefit from antipsychotic, no longer wants to participate in study. D. Patient dropped out, no information available E. Death/Illness F. Administrative 1;3;4;6;10;12;13;16;17;18;19;21;999 01=Positive Symptoms; 03=Mood Symptoms; 04=Other efficacy/inadequate therapeutic effect (specify); 06=Lipids; 10=Akathisia/activation; 12=Insomnia; 13=Agitation; 16=Other unacceptable side effects (specify); 17=Does not see need for or benefit from antipsychotic treatment; 18=No longer wants to participate in study (but will still take meds); 19=Patient dropped out, no information available; 21=Administrative (specify); 999= Legitimately skipped
Query rtda3_1 Integer Recommended What was the primary reason the study treatment was stopped? 01::19; 999 01=Weight; 02=Diarrhea; 03=Nausea; 04=Vomiting; 05=Abdominal Discomfort; 06=Headache; 07=Weakness; 08=Muscle Pain; 09=Alcohol Use; 10=Lipids; 11=Glucose; 12=GGT; 13=Other; 14=Patient Refusal:Does not see need for or benefit from study medication; 15=Patient Refusal: Unacceptable side effects; 16=Patient Refusal: No longer wants to participate in study; 17=Patient dropped out, no information available; 18=Death/Illness; 19=Administrative; 999=Legitimately skipped
tx_pd_oth_spec String 30 Recommended Reason for discontinuation: Specify 'other' reason
tx_lt8_complete Integer Recommended Did the participant complete less than 8 treatment sessions 1;2 1 = Yes; 2 = No
final_tx_date Date Recommended Date of final treatment
final_tx_num Integer Recommended Final treatment number 1::21
tx_prm_discon Integer Recommended Was treatment prematurely discontinued 1;2 1 = Yes; 2 = No
tx_pd_wrse_dprs Integer Recommended Reason for discontinuation: worsening depression 1;2 1 = Yes; 2 = No
tx_pd_inc_si Integer Recommended Reason for discontinuation: increase in suicidal ideation 1;2 1 = Yes; 2 = No
tx_pd_manic Integer Recommended Reason for discontinuation: clinically significant hypomanic or manic symptoms 1;2 1 = Yes; 2 = No
tx_pd_consent Integer Recommended Reason for discontinuation: withdrew consent 1;2 1 = Yes; 2 = No
tx_pd_miss_seiz Integer Recommended Reason for discontinuation: Missed seizures on 2 consecutive treatment sessions 1;2 1 = Yes; 2 = No
tx_pd_noncomp Integer Recommended Reason for discontinuation: Non-compliance with treatment schedule 1;2 1 = Yes; 2 = No
tx_pd_oth Integer Recommended Reason for discontinuation: Other reason 1;2 1 = Yes; 2 = No
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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