|
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=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 = 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 |
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ecgcmnt, ecgcom, notes |
Query
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visnum |
Float |
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Recommended |
Numeric Visit Number |
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-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
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lab020 |
Date |
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Recommended |
Date of PI/clinician signature |
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ecg004, ecg008 |
Query
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comp_assess |
Integer |
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Recommended |
Please indicated when assessment completed |
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1=Pre-infusion; 2=Post-infusion; -9=Unknown
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ecg00a |
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date_updated |
Date |
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Recommended |
Date record updated |
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edit_date |
Query
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trtgroup |
String |
2
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Recommended |
Treatment Group |
N1;N2;R1;R2;R3
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N1=Non-Responder Entering Fluvoxamine; N2=Non-Responder Entering Fluoxetine; R1=Maintenance; R2=Responder Entering Fluvoxamine; R3=Responder Entering Fluoxetine
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Query
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week |
Float |
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Recommended |
Week in level/study |
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99=week 10-week 14
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intid |
Query
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study_id |
Integer |
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Recommended |
Study ID number |
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46=Acute Phase; 47=Stabilization Phase
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Query
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ecgdone |
String |
2
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Recommended |
Was ECG performed at this assessment? |
Y;N
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subj_pos |
String |
20
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Recommended |
Position of subject |
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Sitting; Supine; Prone; Standing
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ecgpos |
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ncsspec |
String |
100
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Recommended |
Specify Abnormal, not clinically significant result |
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csspec |
String |
100
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Recommended |
Specify Abnormal, clinically significant result |
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Query
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ci_enrolled |
Integer |
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Recommended |
Participant enrolled |
0;1
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0=No; 1=Yes
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enrolled |
Query
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sitedatasource_1 |
Integer |
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Recommended |
Source of Data: Site |
0;1; -888; -999
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0=False; 1=True; -888=Not Applicable; -999=Missing;
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infosrcr |
Query
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sitedatasource_phone |
Integer |
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Recommended |
Source of Data: Telephone |
0;1; -888; -999
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0=False; 1=True; -888=Not Applicable; -999=Missing;
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infosrct |
Query
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sitedatasource_physician |
Integer |
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Recommended |
Source of Data: Physician |
0;1; -888; -999
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0=False; 1=True; -888=Not Applicable; -999=Missing;
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infosrcp |
Query
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ecg_p |
Integer |
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Recommended |
P axis |
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Query
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ecg_r |
Integer |
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Recommended |
R axis |
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Query
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ecg_t |
Integer |
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Recommended |
T axis |
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Query
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heart_rate |
Integer |
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Recommended |
heart rate |
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rate, ventrate |
Query
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ecg_hrld |
Float |
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Recommended |
ECG: Hours since last dose |
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Query
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ecg_nrml |
Integer |
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Recommended |
ECG: Normal - yes (1) or no (0)? |
0; 1; -888
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0 = No; 1 = Yes; -888= NA
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Query
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ecg_sgch |
Integer |
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Recommended |
ECG: Significant change - yes (1) or no? |
0; 1; -888
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0 = No; 1 = Yes; -888= NA
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Query
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ecg_sfpr |
Integer |
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Recommended |
ECG: Do any values exceed safety parameters? |
0; 1
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0 = No; 1 = Yes
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Query
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ecg_cardiac |
Integer |
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Recommended |
ECG: Cardiac Consult Action Taken |
0; 1
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0 = No; 1 = Yes
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Query
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ecg_wthdrawn |
Integer |
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Recommended |
ECG: Withdrawn Action Taken |
0; 1
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0 = No; 1 = Yes
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Query
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ecg_wdrawdte |
Integer |
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Recommended |
ECG: Withdrawn Date if Applicable (days offset from randomization date) |
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Offset from randomization date (days)
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Query
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me2 |
Integer |
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Recommended |
Status |
0;1
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0 = Past [Inactive]; 1 = Active
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Query
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ekg |
Integer |
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Recommended |
ekg normal abnormal |
1;2
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1=Within normal range; 2=Out of range
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midihist_008a |
String |
250
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Recommended |
Other cardiac describe |
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Query
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sigp1 |
Integer |
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Recommended |
Physician signature present |
0;1
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0 = No; 1 = Yes
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Query
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sigd1 |
Integer |
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Recommended |
Physician/PI signature date (days since randomization) |
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Query
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ecgrdby |
Integer |
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Recommended |
ECG Read By: |
1::4
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1 = Computer; 2 = Hand; 3 = ECG not readable; 4 = Computer & Hand (double check)
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Query
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qtchnd |
Integer |
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Recommended |
QTC value: rechecked by hand |
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Query
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qthnd |
Integer |
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Recommended |
QT value: rechecked by hand |
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Query
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q71ck |
Integer |
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Recommended |
Left Atrial Hypertrophy |
0;1
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0 = No; 1 = Yes
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Query
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q73ck |
Integer |
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Recommended |
Right Atrial Hypertrophy |
0;1
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0 = No; 1 = Yes
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Query
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quest71 |
Integer |
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Recommended |
Abnormality Clinically Significant? Left Atrial Hypertrophy |
0;1
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0 = No; 1 = Yes
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Query
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quest75 |
Integer |
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Recommended |
Abnormality Clinically Significant? Left Ventricular Hypertrophy |
0;1
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0 = No; 1 = Yes
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Query
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quest77 |
Integer |
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Recommended |
Abnormality Clinically Significant? Right Ventricular Hypertrophy |
0;1
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0 = No; 1 = Yes
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Query
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quest712 |
Integer |
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Recommended |
Abnormality Clinically Significant? Other rhythm abnormalities? |
0;1
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0 = No; 1 = Yes
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Query
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quest722 |
Integer |
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Recommended |
Abnormality Clinically Significant? LBB Block |
0;1
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0 = No; 1 = Yes
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Query
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quest723 |
Integer |
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Recommended |
Abnormality Clinically Significant? Other Non-specific ST/T |
0;1
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0 = No; 1 = Yes
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Query
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quest724 |
Integer |
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Recommended |
Abnormality Clinically Significant? RBB Block |
0;1
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0 = No; 1 = Yes
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Query
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quest725 |
Integer |
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Recommended |
Abnormality Clinically Significant? Sinus Tachycardia |
0;1
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0 = No; 1 = Yes
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Query
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quest728 |
Integer |
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Recommended |
Abnormality Clinically Significant? Other Intraventricular Cond. Block |
0;1
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0 = No; 1 = Yes
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Query
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quest729 |
Integer |
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Recommended |
Abnormality Clinically Significant? Supraventric premature beat |
0;1
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0 = No; 1 = Yes
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Query
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quest730 |
Integer |
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Recommended |
Abnormality Clinically Significant? Other |
0;1
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0 = No; 1 = Yes
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rsa |
String |
50
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Recommended |
Respiratory Sinus Arrhythmia (RSA) Reactivity |
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rsa_b, rsa_r_anag, rsa_r_frienddeb, rsa_r_gtky, rsa_r_spchpres, rsa_r_spchprp |
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pep |
String |
50
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Recommended |
Pre-ejection Period (PEP) Reactivity |
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pep_b, pep_r_anag, pep_r_frienddeb, pep_r_gtky, pep_r_spchpres, pep_r_spchprp |
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data_file1 |
File |
255
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Recommended |
Data file 1 |
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data_file2 |
File |
255
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Recommended |
data file 2 |
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data_file3 |
File |
255
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Recommended |
Data file 3 |
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Query
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timept |
Integer |
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Recommended |
Time Point |
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888 = not applicable; 999 = missing
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Query
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form_explain |
Integer |
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Recommended |
Why was this form not completed? |
86::99
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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
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formcomplete |
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other_reason_nc |
String |
100
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Recommended |
Other reason form was not completed |
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fcspecify |
Query
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qrsvolt |
Integer |
|
Recommended |
Increased QRS voltage: |
0;1
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0 = No; 1 = Yes
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|
Query
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ventri_rate |
Integer |
|
Recommended |
Ventricular Rate (bpm) |
0::999
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same_ecg1 |
Query
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qtcprolong |
Integer |
|
Recommended |
QTc prolongation |
0;1;-7
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0=No; 1=Yes; -7=Refused
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scrflexc |
String |
500
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Recommended |
Failed these exclusion criteria: |
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excl1 |
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ncstk |
String |
50
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Recommended |
The name of the task being completed during the recording |
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ekgdate |
Date |
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Recommended |
EKG Result Date |
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ecg_done |
Integer |
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Recommended |
Was an ECG obtained? |
0;1
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0=No; 1=Yes
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ecg_no_reason |
String |
4,000
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Recommended |
Was an ECG obtained? No, explain |
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ecg_signif |
Integer |
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Recommended |
Were there any significant findings? |
0;1
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0=No; 1=Yes
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ecg_signif_explain |
String |
4,000
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Recommended |
Explain significant findings |
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ecttime |
String |
5
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Recommended |
Time of ECG. HH:MM |
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24 hour clock
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comments |
String |
4,000
|
Recommended |
Comments about assessment |
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same_ecg14 |
Integer |
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Recommended |
Presence of Ascites? |
1::3
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1 = Yes; 2 = No; 3 = Not Screened
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same_ecg15 |
Integer |
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Recommended |
Presence of HCC? |
1::3
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1 = Yes; 2 = No; 3 = Not Screened
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same_ecg16 |
Integer |
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Recommended |
Splenomegaly? |
1::3
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1 = Yes; 2 = No; 3 = Not Screened
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same_ecg17 |
Integer |
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Recommended |
Has the patient had a Fibroscan within the last 12 weeks? |
1;2
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1 = Yes; 2 = No
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same_ecg18 |
Date |
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Recommended |
If yes, indicate the date of Fibroscan |
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(MM/DD/YYYY)
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same_ecg19 |
String |
5
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Recommended |
Type of probe (M/XL) |
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same_ecg20 |
Integer |
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Recommended |
Fibroscan stiffness (medican, in kPa) |
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kPa
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same_ecg21 |
Integer |
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Recommended |
Inter Quartile Range (IQR) |
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same_ecg22 |
Integer |
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Recommended |
IQR/median |
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Percentage
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same_ecg23 |
Integer |
|
Recommended |
Total number of measurements (valid plus invalid) |
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same_ecg24 |
Integer |
|
Recommended |
Success Rate (SR) |
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Percentage
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same_ecg25 |
Integer |
|
Recommended |
Child Pugh Scores |
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same_ecg26 |
Integer |
|
Recommended |
MELD Scores |
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same_ecg7 |
Date |
|
Recommended |
Date of endoscopy exam |
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(MM/DD/YYYY)
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same_ecg8 |
Integer |
|
Recommended |
Presence of esophageal varices? |
1::3
|
1 = Yes; 2 = No; 3 = Not Screened
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same_ecg9 |
Integer |
|
Recommended |
If yes, size of varices |
1::3
|
1 = Mid; 2 = Moderate; 3 = Large
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same_ecg10 |
Integer |
|
Recommended |
Portal or gastric varices? |
1::3
|
1 = Yes; 2 = No; 3 = Not Screened
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same_ecg11 |
Integer |
|
Recommended |
Presence of portal hypertensive gastropathy? |
1::3
|
1 = Yes; 2 = No; 3 = Not Screened
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same_ecg12 |
Date |
|
Recommended |
Date of CT scan |
|
(MM/DD/YYYY)
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same_ecg13 |
Integer |
|
Recommended |
CT evidence of cirrhosis? |
1::3
|
1 = Yes; 2 = No; 3 = Not Screened
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