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ECG Results

6,547 Shared Subjects

Clinical Trials: ECG Results
Clinical Assessments
Phys Exam
05/07/2014
ecg01
02/22/2024
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* 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::1440 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

Please email the The NDA Help Desk with any questions.