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NIMH Data Archive
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NDA Help Center

Filter Cart

Viewable at the top right of NDA pages, the Filter Cart is a temporary holder for filters and data they select. Filters are added to the Workspace first, before being submitted to The Filter Cart. Data selected by filters in the Filter Cart can be added to a Data Package or an NDA Study from the Data Packaging Page, by clicking the 'Create Data Package / Add Data to Study' button.

The filter cart supports combining multiple filters together, and depending on filter type will use "AND" or "OR" when combining filters.

Multiple selections from the same filter type will result in those selections being applied with an ‘OR’ condition. For example, if you add an NDA Collection Filter with selections for both collections 2112 and 2563 to an empty Workspace, the subjects from NDA Collection 2112 ‘OR’ NDA Collection 2563 will be added to your Workspace even if a subject is in both NDA Collections. You can then add other NDA Collections to your Workspace which further extends the ‘OR’ condition.

If a different filter type is added to your Workspace, or a filter has already been submitted to the Filter Cart, the operation then performs a logical ‘AND’ operation. This means that given the subjects returned from the first filter, only those subjects that matched the first filter are returned by the second filter (i.e., subjects that satisfied both filters).

When combining other filters with the GUID filter, please note the GUID filter should be added last. Otherwise, preselected data may be lost. For example, a predefined filter from Featured Datasets may select a subset of data available for a subject. When combined with a GUID filter for the same subject, the filter cart will contain all data available from that subject, data structure, and dataset; this may be more data than was selected in the predefined filter for that subject. Again, you should add the GUID Filter as the last filter to your cart. This ensures 'AND' logic between filters and will limit results to the subjects, data structures, and datasets already included in your filter cart.

Note that only the subjects specific to your filter will be added to your Filter Cart and only on data shared with the research community. Other data for those same subjects may exist (i.e., within another NDA Collection, associated with a data structure that was not requested in the query, etc.). So, users should select ‘Find all Subjects Data’ to identify all data for those specific subjects.

Additional Tips:

  • You may query the data without an account, but to gain access you will need to create an NDA user account and apply for access. Most data access requires that you or your lab are sponsored by an NIH recognized institution with Federal Wide Assurance (FWA). Without access, you will not be able to obtain individual-level data.

Once you have selected data of interest you can:

  • Create a data package - This allows you to specify format for access/download
  • Assign to Study Cohort - Associate the data to an NDA Study allowing for a DOI to be generated and the data to be linked directly to a finding, publication, or data release.
  • Find All Subject Data - Depending on filter types being used, not all data associated with a subject will be selected. Data may be restricted by data structure, NDA Collection, or outcome variables (e.g., NDA Study). ‘Find All Data’ expands the filter criteria by replacing all filters in your Filter Cart with a single Query by GUID filter for all subjects selected by those filters.

Please Note:

  • When running a query, it may take a moment to populate the Filter Cart. Queries happen in the background so you can define other queries during this time.
  • When you add your first filter, all data associated with your query will be added to the Filter Cart (e.g., a Concept, an NDA Collection, a Data Structure/Element, etc.). As you add additional filters, they will also display in the Filter Cart. Only the name of filter will be shown in the Filter Cart, not the underlying structures.
  • Information about the contents of the Filter Cart can be seen by clicking "Edit”.
  • Once your results appear in the Filter Cart, you can create a data package or assign subjects to a study by selecting the 'Package/Assign to Study' option. You can also 'Edit' or 'Clear' filters.

Frequently Asked Questions

  • What is a Filter Cart?
    Viewable at the top right of NDA pages, the Filter Cart is a temporary holder of data identified by the user, through querying or browsing, as being of some potential interest. The Filter Cart is where you send the data from your Workspace after it has been filtered.
  • What do I do after filters are added to the Filter Cart?
    After filters are added to the Filter Cart, users have options to ‘Create a Package’ for download, ‘Associate to Study Cohort’, or ‘Find All Subject Data’. Selecting ‘Find All Subject Data’ identifies and pulls all data for the subjects into the Filter Cart. Choosing ‘Create a Package’ allows users to package and name their query information for download. Choosing ‘Associate to Study Cohort’ gives users the opportunity to choose the Study Cohort they wish to associate this data.
  • Are there limitations on the amount of data a user can download?

    NDA limits the rate at which individual users can transfer data out of Amazon Web Services (AWS) S3 Object storage to non-AWS internet addresses. All users have a download limit of 20 Terabytes. This limit applies to the volume of data an individual user can transfer within a 30-day window. Only downloads to non-AWS internet addresses will be counted against the limit.

  • How does Filter Cart Boolean logic work?

    The Filter Cart currently employs basic AND/OR Boolean logic. A single filter may contain multiple selections for that filter type, e.g., a single NDA Study filter might contain NDA Study 1 and NDA Study 2. A subject that is in EITHER 1 OR 2 will be returned. Adding multiple filters to the cart, regardless of type, will AND the result of each filter. If NDA Study 1 and NDA Study 2 are added as individual filters, data for a subject will only be selected if the subject is included in BOTH 1 AND 2.

    When combining other filters with the GUID filter, please note the GUID filter should be added last. Otherwise, preselected data may be lost. For example, a predefined filter from Featured Datasets may select a subset of data available for a subject. When combined with a GUID filter for the same subject, the filter cart will contain all data available from that subject, data structure, and dataset; this may be more data than was selected in the predefined filter for that subject. Again, you should add the GUID Filter as the last filter to your cart. This ensures 'AND' logic between filters and will limit results to the subjects, data structures, and datasets already included in your filter cart.

Glossary

  • Workspace
    The Workspace within the General Query Tool is a holding area where you can review your pending filters prior to adding them to Filter Cart. Therefore, the first step in accessing data is to select one or more items and move it into the Workspace.
  • Filter Cart
    Viewable at the top right of NDA pages, the Filter Cart is a temporary holder of data identified by the user through querying or browsing as being of some potential interest. The Filter Cart adds data using an AND condition. The opportunity to further refine data to determine what will be downloaded or sent to a miNDAR is available on the Data Packaging Page, the next step after the Filter Cart. Subsequent access to data is restricted by User Permission or Privilege; however Filter Cart use is not.
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ECG Results

6,450 Shared Subjects

Clinical Trials: ECG Results
Clinical Assessments
Phys Exam
05/07/2014
ecg01
08/24/2023
View Change History
01
Definition
Submission Template
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* guid
src_subject_id String 20 Required Subject ID how it's defined in lab/project CATIEID, case_id, patid, randid, stepid, subject_id, subjectid, subjid
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, intvage
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY ecg_visit_date, ecgdt, ekg002, intvdate, visit_date
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
Query visitid Integer Recommended MetaTrial Visit ID System variable: unique code for each type of visit -use to merge files
Query visit String 60 Recommended Visit name ekg_interval, int1, interval, visit_name
Query truncvis Integer Recommended Truncated Visit Number Created variable: provides a numeric visit number for all visits, including unscheduled and end of phase
Query phase_ct String 20 Recommended Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1 phase
Query visday Integer Recommended Number of days from study baseline to date of visit ekg_visitdat_x
ecgtm String 15 Recommended ECG Time ecg002
Query ecgint Integer Recommended Physician Interpretation 1::4;7 1=Normal; 2=Abnormal (not clinically significant); 3=Abnormal (clinically significant); 4=Uninterpretable; 7=Incomplete Analysis ecg007, ecgnorm, fuekgq1_no
Query diag1 String 50 Recommended Diagnosis 1 Interpretation from the central ECG center other_specify1
diag2 String 50 Recommended Diagnosis 2 Diagnosis from the central ECG center other_specify2
diag3 String 50 Recommended Diagnosis 3 Diagnosis from the central ECG center
Query diag4 String 250 Recommended Diagnosis
Query diag5 String 50 Recommended Diagnosis 5 Diagnosis from the central ECG center
Query diag6 String 50 Recommended Diagnosis 6 Diagnosis from the central ECG center
Query diag7 String 50 Recommended Diagnosis 7 Diagnosis from the central ECG center
diag8 String 50 Recommended Diagnosis 8 Diagnosis from the central ECG center
diag9 String 50 Recommended Diagnosis 9 Diagnosis from the central ECG center
diag10 String 50 Recommended Diagnosis 10 Diagnosis from the central ECG center
Query ecghr Float Recommended ECG HR bslhr_no, ekg1, hrtrtvl, ventrate
Query ecgpr Float Recommended ECG PR / PR Interval bslpr_no, ekg2, pr, prdurat, printvl, same_ecg2
Query ecgqrs Float Recommended ECG QRS / QRS Duration bslqrs_no, ecg005, ekg3, qrs, qrsdurat, qrsdurvl, same_ecg3
Query ecgqt Float Recommended ECG QT / QT Interval bslqt_no, ekg4, qt, qtc, qtdurat, qtintvl, same_ecg4
Query ecgqtc Float Recommended ECG QTC / QTc Interval ecg006, ekg5, qtc, qtcfint, qtcform, same_ecg5
Query ecgaxis Integer Recommended ECG AXIS
Query crfint Integer Recommended ECG Results / Findings
0::3
0=Normal;1=Abnormal, Not Clinically Significant;2= Abnormal, Clinically Significant; 3=not assessed ecg003, ecgnorm, ecgread, ekg003, ekg9, ekg_q02, same_ecg6
Query base11a_ecg Integer Recommended Ph1/1A Baseline ECG Interpretaion 1::3 1= Normal; 2= Abnormal (not clinically significant); 3= Abnormal (clinically significant) BASE11A, base1
Query base1b_ecg Integer Recommended Ph1B Baseline ECG Interpretaion 1::3 1= Normal; 2= Abnormal (not clinically significant); 3= Abnormal (clinically significant) BASE1B
Query base2_ecg Integer Recommended Ph2 Baseline ECG Interpretaion 1::3 1= Normal; 2= Abnormal (not clinically significant); 3= Abnormal (clinically significant) BASE2
Query base3_ecg Integer Recommended Ph3 Baseline ECG Interpretaion 1::3 1= Normal; 2= Abnormal (not clinically significant); 3= Abnormal (clinically significant) BASE3
Query b1_qt Integer Recommended Ph1/1A Baseline ECG QT Length
Query b1b_qt Integer Recommended Ph1B Baseline ECG QT Length
Query b2_qt Integer Recommended Ph2 Baseline ECG QT Length
Query b3_qt Integer Recommended Ph3 Baseline ECG QT Length
Query ilast11a Integer Recommended Indicator Last Interpretation Ph1/1A 1 1=Yes for all records meeting this criteria ilast1
Query ilast1b Integer Recommended Indicator Last Interpretation Ph1b 1 1=Yes for all records meeting this criteria
Query ilast2 Integer Recommended Indicator Last Interpretation Ph2 1 1=Yes for all records meeting this criteria
Query ilast3 Integer Recommended Indicator Last Interpretation Ph3 1 1=Yes for all records meeting this criteria
Query qtlst11a Integer Recommended Indicator Last QT Length Ph1/1A 1 1=Yes for all records meeting this criteria
Query qtlst1b Integer Recommended Indicator Last QT Length Ph1b 1 1=Yes for all records meeting this criteria
Query qtlst2 Integer Recommended Indicator Last QT Length Ph2 1 1=Yes for all records meeting this criteria
Query qtlst3 Integer Recommended Indicator Last QT Length Ph3 1 1=Yes for all records meeting this criteria
Query csphase Integer Recommended Indicator for CS ECG where Base# not CS 1 1=Yes for all records meeting this criteria
Query c_qt Integer Recommended Phase Specific CFB for QT Length Phase-specific change (within each phase, change is calculated from that phase's baseline measurement)
Query csprev Integer Recommended Indicator for CS ECG when last ECG not C 1 1= if patient has a clinically significant post-baseline ECG, and their previous ECG within that phase was not clinically significant; missing otherwise
Query prolqtc1 Integer Recommended Prolonged QTC in Phase 1/1A 1 1= if patient is (male and has a QTC value > 450 and has a non-missing baseline QTC value <= 450) or (female and has a QTC value > 470 and has a non-missing baseline QTC value <= 470); missing otherwise
Query certcode Integer Recommended stepbd certification code
Query daysrz Integer Recommended days since randomization studyday, testrz
Query lahyper Integer Recommended left arterial hypertrophy 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_1, ekg_q04, fuekgq1_1
Query rahyper Integer Recommended right arterial hypertrophy 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_2, ekg_q05, fuekgq1_2
Query lvhyper Integer Recommended left ventricular hypertrophy 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_3, ekg_q06, fuekgq1_3, lvh
Query rvhyper Integer Recommended right ventricular hypertrophy 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_4, ekg_q07, fuekgq1_4, rvh
Query acinf Integer Recommended acute infarction 0;1;-7 0=No; 1=Yes; -7=Refused ai, ec_q1_5, ekg_q08, fuekgq1_5
Query subacinf Integer Recommended subacute infarction 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_6, ekg_q09, fuekgq1_6, si
Query oldinf Integer Recommended old infarction 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_7, ekg_q10, fuekgq1_7, oi
Query myocinf Integer Recommended myocardial ischemia 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_8, ekg_q11, fuekgq1_8, mi
Query digital Integer Recommended digitalis effect 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_9, ekg_q12, fuekgq1_9
Query twave Integer Recommended symmetrical t wave inversions 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_10, ekg_q13, fuekgq1_10, stwi
Query rwave Integer Recommended poor r wave progression 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_11, ekg_q14, fuekgq1_11, prp
Query stt Integer Recommended other non specific st/t 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_12, ekg_q15, fuekgq1_12, onst
Query sinust Integer Recommended sinus tachycardia 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_13, ekg_q16, fuekgq1_13, sinustach
Query sinusb Integer Recommended sinus bradycardia 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_14, ekg_q17, fuekgq1_14, sb
Query spbeat Integer Recommended supraventric premature beat 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_15, ekg_q18, fuekgq1_15, spb
Query vpbeat Integer Recommended ventricular premature beat 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_16, ekg_q19, fuekgq1_16, vpb
Query stachy Integer Recommended supraventricular tachycardia 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_17, ekg_q20, fuekgq1_17, supratach
Query vtachy Integer Recommended ventricular tachycardia 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_18, ekg_q21, fuekgq1_18, vt
Query afib Integer Recommended atrial fibrillation 0;1;-7;-9 0=No; 1=Yes; -7=Refused; -9 = Not applicable or Missing ec_q1_19, ekg_q22, fuekgq1_19
Query aflutter Integer Recommended atrial flutter 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_20, ekg_q23, fuekgq1_20
Query rhythm Integer Recommended other rhythm abnormalities 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_21, ekg_q24, fuekgq1_21
Query pacemake Integer Recommended implanted pacemaker 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_22, ekg_q25, fuekgq1_22
Query av1st Integer Recommended 1st degree av block 0;1;-7 0=No; 1=Yes; -7=Refused davb1, ec_q1_23, ekg_q26, fuekgq1_23
Query av2nd Integer Recommended 2nd degree av block 0;1;-7 0=No; 1=Yes; -7=Refused davb2, ec_q1_24, ekg_q27, fuekgq1_24
Query av3rd Integer Recommended 3rd degree av block 0;1;-7 0=No; 1=Yes; -7=Refused davb3, ec_q1_25, ekg_q28, fuekgq1_25
Query lbb Integer Recommended lbb block 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_26, ekg_q29, fuekgq1_26, lbbb
Query rbb Integer Recommended rbb block 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_27, ekg_q30, fuekgq1_27, rbbb
Query pesynd Integer Recommended pre excitation syndrome 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_28, ekg_q31, fuekgq1_28
Query oicond Integer Recommended other intraventric cond block 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_29, ekg_q32, fuekgq1_29
Query oabn Integer Recommended other abnormality 0;1;-7 0=No; 1=Yes; -7=Refused ec_q1_30, ekg_q33, fuekgq1_30
Query site String 101 Recommended Site Study Site site_id, site_no, site_uid, siteid
Query bslhr_rpt Integer Recommended EKG lab value repeated - HR 1;2 1=no;2=yes
Query bslpr_rpt Integer Recommended EKG lab value repeated - PR 1;2 1=no;2=yes
Query bslqrs_rpt Integer Recommended EKG lab value repeated - QRS 1;2 1=no;2=yes
Query bslqt_rpt Integer Recommended EKG lab value repeated - QTc 1;2 1=no;2=yes
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; EG 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; EG= Experimental 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
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 study_drug_team String 30 Recommended Study drug Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA
Query ekg001 Integer Recommended Was an EKG performed on this subject? 0;1 0=No; 1=Yes ecg001, ekg_q01, q01, status
ekg004 String 500 Recommended Describe abnormalities: (At screening, justify enrollment of subject. At weeks 4 or 6, enter AE.) ecg003a, ecg007a
Query study String 100 Recommended Study; The code for each individual study ekg_studyid, studyid
Query completed Integer Recommended Checks if completed 0::3 0=No; 1=Yes; 2=Yes, lost; 3=Unverified ekg_frmcomp, formcomp, frmcomp
Query subtrial_name Integer Recommended Name of subtrial 1::3 1=Crossover; 2=Guanfacine; 3= Open Label MPH
Query ec_q1_no Integer Recommended No Abnormalities 1 1=No Abnormalities noabn
Query ec_q2 Integer Recommended Do items exclude individual from study 0;1 0=No; 1=Yes ekg_q34, exclude, fuekgq1_34
Query dateread Integer Recommended Date the ECG was read in days from the randomization date
Query session_id String 20 Recommended session ID/screening ID screeningid
Query version_form String 121 Recommended Form used/assessment name form_name
Query ecgstrth Integer Recommended ECG Start Time Hours
Query ecgstrtm Integer Recommended ECG Start Time Minutes
Query ecgendth Integer Recommended ECG End Time Hours
Query ecgendtm Integer Recommended ECG End Time Minutes
Query ecgtyp Integer Recommended ECG Type 1::3 1=3 Lead; 2=5 Lead; 3=12 Lead (required at screening)
Query rrintvl Float Recommended RR Interval Value
comments_misc String 4,000 Recommended Miscellaneous comments on study, interview, methodology relevant to this form data ecgcmnt, ecgcom, notes
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
lab020 Date Recommended Date of PI/clinician signature ecg004, ecg008
Query comp_assess Integer Recommended Please indicated when assessment completed
1;2;-9
1=Pre-infusion; 2=Post-infusion; -9=Unknown ecg00a
date_updated Date Recommended Date record updated edit_date
Query trtgroup String 2 Recommended Treatment Group N1;N2;R1;R2;R3 N1=Non-Responder Entering Fluvoxamine; N2=Non-Responder Entering Fluoxetine; R1=Maintenance; R2=Responder Entering Fluvoxamine; R3=Responder Entering Fluoxetine
Query week Float Recommended Week in level/study 99=week 10-week 14 intid
Query study_id Integer Recommended Study ID number 46=Acute Phase; 47=Stabilization Phase
Query ecgdone String 2 Recommended Was ECG performed at this assessment? Y;N
subj_pos String 20 Recommended Position of subject Sitting; Supine; Prone; Standing ecgpos
ncsspec String 100 Recommended Specify Abnormal, not clinically significant result
csspec String 100 Recommended Specify Abnormal, clinically significant result
Query ci_enrolled Integer Recommended Participant enrolled 0;1 0=No; 1=Yes enrolled
Query sitedatasource_1 Integer Recommended Source of Data: Site 0;1; -888; -999 0=False; 1=True; -888=Not Applicable; -999=Missing; infosrcr
Query sitedatasource_phone Integer Recommended Source of Data: Telephone 0;1; -888; -999 0=False; 1=True; -888=Not Applicable; -999=Missing; infosrct
Query sitedatasource_physician Integer Recommended Source of Data: Physician 0;1; -888; -999 0=False; 1=True; -888=Not Applicable; -999=Missing; infosrcp
Query ecg_p Integer Recommended P axis
Query ecg_r Integer Recommended R axis
Query ecg_t Integer Recommended T axis
Query heart_rate Integer Recommended heart rate rate, ventrate
Query ecg_hrld Float Recommended ECG: Hours since last dose
Query ecg_nrml Integer Recommended ECG: Normal - yes (1) or no (0)? 0; 1; -888 0 = No; 1 = Yes; -888= NA
Query ecg_sgch Integer Recommended ECG: Significant change - yes (1) or no? 0; 1; -888 0 = No; 1 = Yes; -888= NA
Query ecg_sfpr Integer Recommended ECG: Do any values exceed safety parameters? 0; 1 0 = No; 1 = Yes
Query ecg_cardiac Integer Recommended ECG: Cardiac Consult Action Taken 0; 1 0 = No; 1 = Yes
Query ecg_wthdrawn Integer Recommended ECG: Withdrawn Action Taken 0; 1 0 = No; 1 = Yes
Query ecg_wdrawdte Integer Recommended ECG: Withdrawn Date if Applicable (days offset from randomization date) Offset from randomization date (days)
Query me2 Integer Recommended Status 0;1 0 = Past [Inactive]; 1 = Active
Query ekg Integer Recommended ekg normal abnormal 1;2 1=Within normal range; 2=Out of range
midihist_008a String 250 Recommended Other cardiac describe
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 ecgrdby Integer Recommended ECG Read By: 1::4 1 = Computer; 2 = Hand; 3 = ECG not readable; 4 = Computer & Hand (double check)
Query qtchnd Integer Recommended QTC value: rechecked by hand
Query qthnd Integer Recommended QT value: rechecked by hand
Query q71ck Integer Recommended Left Atrial Hypertrophy 0;1 0 = No; 1 = Yes
Query q73ck Integer Recommended Right Atrial Hypertrophy 0;1 0 = No; 1 = Yes
Query quest71 Integer Recommended Abnormality Clinically Significant? Left Atrial Hypertrophy 0;1 0 = No; 1 = Yes
Query quest75 Integer Recommended Abnormality Clinically Significant? Left Ventricular Hypertrophy 0;1 0 = No; 1 = Yes
Query quest77 Integer Recommended Abnormality Clinically Significant? Right Ventricular Hypertrophy 0;1 0 = No; 1 = Yes
Query quest712 Integer Recommended Abnormality Clinically Significant? Other rhythm abnormalities? 0;1 0 = No; 1 = Yes
Query quest722 Integer Recommended Abnormality Clinically Significant? LBB Block 0;1 0 = No; 1 = Yes
Query quest723 Integer Recommended Abnormality Clinically Significant? Other Non-specific ST/T 0;1 0 = No; 1 = Yes
Query quest724 Integer Recommended Abnormality Clinically Significant? RBB Block 0;1 0 = No; 1 = Yes
Query quest725 Integer Recommended Abnormality Clinically Significant? Sinus Tachycardia 0;1 0 = No; 1 = Yes
Query quest728 Integer Recommended Abnormality Clinically Significant? Other Intraventricular Cond. Block 0;1 0 = No; 1 = Yes
Query quest729 Integer Recommended Abnormality Clinically Significant? Supraventric premature beat 0;1 0 = No; 1 = Yes
Query quest730 Integer Recommended Abnormality Clinically Significant? Other 0;1 0 = No; 1 = Yes
rsa String 50 Recommended Respiratory Sinus Arrhythmia (RSA) Reactivity rsa_b, rsa_r_anag, rsa_r_frienddeb, rsa_r_gtky, rsa_r_spchpres, rsa_r_spchprp
pep String 50 Recommended Pre-ejection Period (PEP) Reactivity pep_b, pep_r_anag, pep_r_frienddeb, pep_r_gtky, pep_r_spchpres, pep_r_spchprp
data_file1 File 255 Recommended Data file 1
data_file2 File 255 Recommended data file 2
data_file3 File 255 Recommended Data file 3
Query timept Integer Recommended Time Point 888 = not applicable; 999 = missing
Query form_explain Integer Recommended Why was this form not completed? 86::99 99=Participant unable to complete due to cognitive impairment; 98=Participant unable to complete due to physical impairment; 97=Participant refused to begin/finish; 96=Participant completed but with less than best effort; 95=Participant unable to be contacted; 94=Participant deceased; 93=Participant withdrew consent; 92=Time constraints; 91=Rater forgot to administer; 90=Missed appointment; 89=Participant was terminated from study; 88=Other;87 = Not Done (reason unspecified); 86 = Not Applicable formcomplete
other_reason_nc String 100 Recommended Other reason form was not completed fcspecify
Query qrsvolt Integer Recommended Increased QRS voltage: 0;1 0 = No; 1 = Yes
Query ventri_rate Integer Recommended Ventricular Rate (bpm) 0::999 same_ecg1
Query qtcprolong Integer Recommended QTc prolongation 0;1;-7 0=No; 1=Yes; -7=Refused
scrflexc String 500 Recommended Failed these exclusion criteria: excl1
ncstk String 50 Recommended The name of the task being completed during the recording
ekgdate Date Recommended EKG Result Date
ecg_done Integer Recommended Was an ECG obtained? 0;1 0=No; 1=Yes
ecg_no_reason String 4,000 Recommended Was an ECG obtained? No, explain
ecg_signif Integer Recommended Were there any significant findings? 0;1 0=No; 1=Yes
ecg_signif_explain String 4,000 Recommended Explain significant findings
ecttime String 5 Recommended Time of ECG. HH:MM 24 hour clock
comments String 4,000 Recommended Comments about assessment
same_ecg14 Integer Recommended Presence of Ascites? 1::3 1 = Yes; 2 = No; 3 = Not Screened
same_ecg15 Integer Recommended Presence of HCC? 1::3 1 = Yes; 2 = No; 3 = Not Screened
same_ecg16 Integer Recommended Splenomegaly? 1::3 1 = Yes; 2 = No; 3 = Not Screened
same_ecg17 Integer Recommended Has the patient had a Fibroscan within the last 12 weeks? 1;2 1 = Yes; 2 = No
same_ecg18 Date Recommended If yes, indicate the date of Fibroscan (MM/DD/YYYY)
same_ecg19 String 5 Recommended Type of probe (M/XL)
same_ecg20 Integer Recommended Fibroscan stiffness (medican, in kPa) kPa
same_ecg21 Integer Recommended Inter Quartile Range (IQR)
same_ecg22 Integer Recommended IQR/median Percentage
same_ecg23 Integer Recommended Total number of measurements (valid plus invalid)
same_ecg24 Integer Recommended Success Rate (SR) Percentage
same_ecg25 Integer Recommended Child Pugh Scores
same_ecg26 Integer Recommended MELD Scores
same_ecg7 Date Recommended Date of endoscopy exam (MM/DD/YYYY)
same_ecg8 Integer Recommended Presence of esophageal varices? 1::3 1 = Yes; 2 = No; 3 = Not Screened
same_ecg9 Integer Recommended If yes, size of varices 1::3 1 = Mid; 2 = Moderate; 3 = Large
same_ecg10 Integer Recommended Portal or gastric varices? 1::3 1 = Yes; 2 = No; 3 = Not Screened
same_ecg11 Integer Recommended Presence of portal hypertensive gastropathy? 1::3 1 = Yes; 2 = No; 3 = Not Screened
same_ecg12 Date Recommended Date of CT scan (MM/DD/YYYY)
same_ecg13 Integer Recommended CT evidence of cirrhosis? 1::3 1 = Yes; 2 = No; 3 = Not Screened
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:

  • Use the search bar to filter the elements displayed. This will not filter on the Size of Required columns
  • 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

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