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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Physical Examination

6,080 Shared Subjects

N/A
Clinical Assessments
Phys Exam
01/02/2015
pe01
03/07/2023
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 id, patid, randid, record_id, subject_id, subjectid, subjid
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY datacollecteddate, exmdt, intvdate, physdt
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. hrbpage, htwtage, intvage
sex String 20 Required Sex of subject at birth
M;F; O; NR
M = Male; F = Female; O=Other; NR = Not reported gender
Query asstyp Integer Recommended Assessment type 1::20 1=TADS GATE A; 2=TADS GATE B; 3 = TADS Gate C; 4 = TADS Week 6; 5 = TADS Week 12; 6 = TADS Week 18; 7 = TADS Week 24; 8 = TADS Week 30; 9 = TADS Week 36; 10 = TADS F/U Mo 3; 11 = TADS F/U Mo 6; 12 = TADS F/U Mo 9; 13 = TADS F/U Mo 12; 14 = SOFTAD month 6; 15 = SOFTAD month 12; 16 = SOFTAD month 18; 17 = SOFTAD month 24; 18 = SOFTAD month 30; 19 = SOFTAD month 36; 20 = SOFTAD month 42
Query stage Integer Recommended Study stage
0::5; 51::53; 67; -888; -999
0 = Pre-Randomization (TADS) 1 = Stage 1 (TADS) 2 = Stage 2 (TADS) 3 = Stage 3 (TADS) 4 = Stage 4 (TADS) 5 = Stage 5 (SOFTAD); 51=Treatmentas Usual; 52=Screening Alone; 53=Intervention; 67=Unknown; -888=Not Applicable; -999=Missing;
Query bsit0 Float Recommended Weeks from Time 0/baseline to assessment pet0
Query vital_sysbp Float Recommended Blood Pressure (sitting for 3 minutes)mmHg (systolic) 0::500; 999 999=NK/missing bio_clinical_21, bpsys, pesys, phex_q03
Query vital_diabp Integer Recommended Blood Pressure (sitting for 3 minutes)mmHg (diastolic) 0::500 bio_clinical_22, bpdia, pedias, phex_q04
Query heart_rate Integer Recommended heart rate hrtrat, pehr
Query weight_met Float Recommended Weight - Metric Unit 999 = Missing; -999 = No Data bio_clinical_02, pewt, wtkg
Query height_st Float Recommended Body height (inches)[Caution: Beware of extreme outliers] height, peht, phex_q01
Query pehxmen Integer Recommended History of menstruation 0;1 0 = No; 1 = Yes
Query mpt0 Float Recommended Weeks from Time 0 (randomization) to date of last menstrual period pement0
Query pregnan Integer Recommended pregnancy test 0::6;-7;9 0=Negative; 1=Positive; 2=Test not conducted; -7=Refused; 9=NA;3=Not pregnant (per pregnancy test); 4=Not pregnant (has not reached menarche); 5=Pregnancy suspected, but not confirmed; 6 = Equivocal pepregr
Query pepregt Integer Recommended Pregnancy test type 1::3; -9 1 = Urine 2 = Serum 3 = Test not conducted; -9=unknown pre002
Query assbdic String 5 Recommended Assessment Point D;14;E;24;LB;36;72;96;120; 9; B; 3; 7; 144; 168;192; C D=MTA baseline assessment; 14=MTA 14 month assessment; E=MTA early termination assessment; B = MTA Pre-Baseline Screening Assessment (579/579); 09 = MTA 9 Month Assessment (530/530); 24=MTA 24 month assessment; LB=LNCG baseline assessment; 36=MTA and LNCG 3 year assessment; 72=MTA and LNCG 6 year assessment; 96=MTA and LNCG 8 year assessment; 03 = MTA 3 Month Assessment (438/687);120=MTA and LNCG 10 year assessment; 7= 7th Grade Assessment (221/276); 144 = MTA & LNCG 12 Month Assessment (578/578); 168 = MTA & LNCG 14 Month Assessment (585/585); 192 = MTA & LNCG 16 Month Assessment (505/505); C = MTA Pre-Baseline Screening Assessment (78/78) asshwhb
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 relhwhb
Query actbdic Integer Recommended Active status 0::5 0=Inactive-Data collected after the 14 month treatment phase/after early termination from treatment phase/prior to treatment phase; 1=Active-Data collected during the 14 month treatment phase while subject received originally assigned treatment regardless of degree of compliance; 2=Active-This is the last active assessment for subjects who were about to violate treatment arm by receiving alternate treatment; 3=Active-This is the last active assessment for subjects who were about to leave the study by moving away;4=Yes, Active; 5=No, Not Active acthwhb
site String 101 Recommended Site Study Site phex_site_x, site_uid, siteid, sitenum
Query sjtyp Integer Recommended Subject type 1;2 1=MTA randomized trial subject; 2=Local normative comparison group (LNCG) subject
Query days_baseline Integer Recommended Days since baseline hrbpday, htwtday
Query femenst Float Recommended Age (in years) at First Menstrual Period 1::100; 888; 999 888=N/A; 999=missing data
Query height_met Float Recommended Height - Metric Unit 999 = Missing; -999 = No Data bio_clinical_01, htcm
Query pex001a Integer Recommended Evaluation: Oral (mouth) 1::6; -9 1=Normal;2=Abnormal, NOT clinically significant;3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal Excludes; 6=Abnormal Does Not Exclude; -9=Not Evaluated q24
pex001b String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: Oral (mouth)
Query pex002a Integer Recommended Evaluation: HEENT (including thyroid/neck) 1::6; -9 1=Normal;2=Abnormal, NOT clinically significant;3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal Excludes; 6= Abnormal Does Not exlude; -9=Not Evaluated phex_q27
pex002b String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: HEENT (including thyroid/neck) phex_q28
Query pex003a Integer Recommended Evaluation: Cardiovascular
1::7; -9
1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal Excludes; 6=Abnormal Does Not Exclude; 7=Other; -9=Not Evaluated cardio, cdvspe, heart_and_arteries
pex003b String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: Cardiovascular cardiosp, cdvscmt, heart_and_arteries_comments
Query pex004a Integer Recommended Evaluation: Lungs
1::6; -9
1=Normal;2=Abnormal, NOT clinically significant;3=Abnormal, clinically significant; 4=Abnormal;5=Abnormal Excludes; 6=Abnormal Does Not Exclude; -9=Not Evaluated lungpe, phex_q33, respirat
pex004b String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: Lungs lungcmt, phex_q34, respirsp
Query pex005a Integer Recommended Evaluation: Abdomen (including liver, spleen)
1::7; -9
1=Normal;2=Abnormal, NOT clinically significant;3=Abnormal, clinically significant; 4=Abnormal;5=Abnormal Excludes; 6=Abnormal Does Not Exclude;7=Other;-9=Not Evaluated abdmpe, abdomen, abdomin, pe_7, phex_q39, q45
pex005b String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: Abdomen (including liver, spleen) abdmcmt, abdomen_comments, abdomsp, pe_7a, phex_q40
Query pex006a Integer Recommended Evaluation: Extremities 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal Exludes; 6= Abnormal Does Not Exclude; 7=Other; -9=Not Evaluated extremities, extrpe
pex006b String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: Extremities extrcmt, extremities_comments
Query pex007a Integer Recommended Evaluation: Skin 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal Exludes; 6= Abnormal Does Not Exclude; 7=Other; -9=Not Evaluated pe_2, phex_q06, skinpe
pex007b String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: Skin pe_2a, phex_q07, skincmt
Query pex008aa Integer Recommended Evaluation: Neuropsychiatric, Mental Status 1::4; -9 1=Normal;2=Abnormal, NOT clinically significant;3=Abnormal, clinically significant; 4=Abnormal;-9=Not Evaluated
pex008ab String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: Neuropsychiatric, Mental Status
Query pex008ba Integer Recommended Evaluation: Sensory/Motor 1::6; -9 1=Normal;2=Abnormal, NOT clinically significant;3=Abnormal, clinically significant; 4=Abnormal;5=Abnormal Excludes; 6=Abnormal Does Not Exclude;-9=Not Evaluated
pex008bb String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: Sensory/Motor
Query pex009a Integer Recommended Evaluation: Lymph nodes 1::7; -9 1=Normal;2=Abnormal, NOT clinically significant;3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal Excludes; 6= Abnormal Does Not exlude; 7=other; -9=Not Evaluated phex_q30, q57
pex009b String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: Lymph nodes phex_q31
Query pex010a Integer Recommended Evaluation: Musculoskeletal
1::7; -9
1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal Excludes; 6=Abnormal Does Not Exclude; 7=Other; -9=Not Evaluated muscpe, musculoskeletal, musculsk, pe_8, phex_q45, q48
pex010b String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: Musculoskeletal musccmt, musculo_comments, musculsp, pe_8a, phex_q46
Query pex011a Integer Recommended Evaluation: General appearance
1::7; -9
1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal Excludes; 6=Abnormal Does not Exclude; 7=Other; -9=Not Evaluated appear, general_appearance, pe_1, q06
pex011b String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: General appearance appearsp, comments_gneral_appear, pe_1a
Query pex012a Integer Recommended Evaluation: Other 1
1::6; -9
1=Normal;2=Abnormal, NOT clinically significant;3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal Excludes; 6=Abnormal Does Not Exclude;-9=Not Evaluated oth1pe, pe_13, phyother, phys10
pex012 String 250 Recommended Other 1 (specify:) oth1, other_comments, pe_13a, pex014, phyothsp, phys9a
pex012b String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: Other 1 oth1cmt
Query pex013a Integer Recommended Evaluation: Other 2 1::6; -9 1=Normal;2=Abnormal, NOT clinically significant;3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal Excludes; 6=Abnormal Does Not Exclude;-9=Not Evaluated oth2pe, pe_14
pex013 String 250 Recommended Other 2 (specify:) oth2, pe_14a
pex013b String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: Other 2 oth2cmt, pex014b
Query visit String 60 Recommended Visit name int1, interval, phex_interval, visit_name, visitlabel, vtyppmc
Query daysrz Integer Recommended days since randomization studyday, visitdt
study String 100 Recommended Study; The code for each individual study phex_studyid, studyid
Query completed Integer Recommended Checks if completed 0::3 0=No; 1=Yes; 2=Yes, lost; 3=Unverified exmst, formcomp, phex_frmcomp
Query subtrial_name Integer Recommended Name of subtrial 1::3 1=Crossover; 2=Guanfacine; 3= Open Label MPH
Query np_ms Integer Recommended Evaluation of Neuro-Mental Status 1::3; -9 1=Normal 2=Abn. Excludes; 3=Abn. Does Not Exclude; -9=not evaluated
Query rec Integer Recommended Evaluation of Rectal 1::6; -9 1=Normal 2=Abn. Excludes; 3=Abn. Does Not Exclude; 4=Abnormal; 5=Abnormal, NOT clinically significant; 6=Abnormal, clinically significant;-9=not evaluated q69
Query genit Integer Recommended Evaluation of Genital/Pelvic 1::6; -9 1=Normal 2=Abn. Excludes; 3=Abn. Does Not Exclude; 4=Abnormal; 5=Abnormal, NOT clinically significant; 6=Abnormal, clinically significant;-9=not evaluated
session_id String 20 Recommended session ID/screening ID screeningid
version_form String 121 Recommended Form used/assessment name form_name
Query hdnkpe Integer Recommended Head/Neck PE Results 1::7; -9 1=Normal; 2=Abnormal and Not Clinically Significant; 3=Abnormal and Clinically Significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does not Exclude from Study; 7=Other; -9=Not done head_and_neck, pe_3, phys2
hdnkcmt String 250 Recommended Head/Neck comments head_and_neck_comments, pe_3a
Query eyespe Integer Recommended Eyes PE Results 1::7; -9 1=Normal; 2=Abnormal and Not Clinically Significant; 3=Abnormal and Clinically Significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does not Exclude from Study; 7=Other; -9=Not Evaluated phex_q12, q15
pda_s3q9_phto_com_eyes String 255 Recommended Eyes; comments eyescmt, phex_q13
Query earspe Integer Recommended Ears PE Results 1::3 1=Normal; 2=Abnormal and Not Clinically Significant; 3=Abnormal and Clinically Significant phex_q15, q12
pda_s3q16_com_ears String 255 Recommended Ears comments earscmt, phex_q16
Query nosepe Integer Recommended Nose/Throat PE Exam 1::3 1=Normal; 2=Abnormal and Not Clinically Significant; 3=Abnormal and Clinically Significant phex_q18, q21
nosecmt String 250 Recommended Nose/Throat comments phex_q19
Query endope Integer Recommended Endocrine/Diabetes Results 1::7; -9 1=Normal; 2=Abnormal and Not Clinically Significant; 3=Abnormal and Clinically Significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
endocmt String 250 Recommended Endocrine/Diabetes comments
Query neurope Integer Recommended Neurological Results
1::7; -9
1=Normal; 2=Abnormal and Not Clinically Significant; 3=Abnormal and Clinically Significant; 4=Abnormal; 5=Abnormal Excludes; 6=Abnormal Does Not Exclude; 7=Other; -9=Not done neurolog, pex008a_1, phex_q48, phys6, q63
neurocmt String 250 Recommended Neurological comments neurolsp, pex008b_1, phex_q49
oth3 String 250 Recommended Other 3 Description
Query oth3pe Integer Recommended Other 3 Normal 1::3 1=Normal; 2=Abnormal and Not Clinically Significant; 3=Abnormal and Clinically Significant
Query mcg_po_other String 100 Recommended Other 3 comments oth3cmt
Query pre004 Integer Recommended Pregnancy Test Result 1;2;9;-9 1=Positive; 2=Negative; 9=Equivocal; -9=Unknown
Query pre001 Integer Recommended Was a pregnancy test done? 0;1; 3; -9 0=No; 1=Yes; -9 =unknown; 3=N/A
strf_15 Date Recommended Initial pregnancy test date pre003
lab020 Date Recommended Date of PI/clinician signature pex015, pre005
pex012b_1 String 250 Recommended Rectal Abnormality description
pex013b_1 String 250 Recommended Genital Pelvic Abnormality Description
Query bsln_bmi Float Recommended Baseline BMI
Query labsample20 Integer Recommended Past week: Have you taken any Nonsteroidal Anti-Inflammatory (NSAIDs) 0;1 0=No; 1=Yes bio_clinical_03
Query labsample21 Integer Recommended Past week: Have you taken any oral steroids 0;1 0=No; 1=Yes bio_clinical_04
Query labsample22 Integer Recommended Past week: Have you taken any allergy or cold medications 0;1 0=No; 1=Yes bio_clinical_05
Query labsample23 Integer Recommended Past week: Have you taken any antibiotics 0;1 0=No; 1=Yes bio_clinical_06
Query labsample24 Integer Recommended Past week: Have you taken any diet pills 0;1 0=No; 1=Yes bio_clinical_07
Query labsample25 Integer Recommended Past week: Have you taken any vitamins or other supplements 0;1 0=No; 1=Yes bio_clinical_08
labsample26 String 10 Recommended Time that subject last ate or drank fluid with calories NA=Non-user bio_clinical_09
labsample27 String 100 Recommended Time since subject last smoked tobacco NA=Non-user bio_clinical_10
labsample28 String 10 Recommended Time since subject last smoked marijuana NA=Non-user bio_clinical_11
labsample29 String 10 Recommended Date of last menstrual period NA=if male or pre-puberty bio_clinical_12
Query labsample30 Integer Recommended Have you been sick in the past month? 0;1 0=No; 1=Yes bio_clinical_13
labsample31 String 10 Recommended Last time you had any symptoms: sick NA=Not Applicable bio_clinical_14
Query labsample32 Integer Recommended Past month: symptom severity 1::4 1=Not ill in past month; 2=Mild symptoms; 3=Moderate symptoms; 4=Severe bio_clinical_15
Query labsample33 Integer Recommended Past month: fever 0::3 0=No; 1=Yes; 2=Not sure; 3=NA bio_clinical_16
Query labsample34 Integer Recommended Current acne severity 1::3 1=Clear/Absent; 2=Mild; 3=Moderate/Severe bio_clinical_17
Query labsample35 Integer Recommended Have you been sunburned in the past week? 0;1 0=No; 1=Yes bio_clinical_18
Query labsample36 Integer Recommended If sunburned, how much of your body was involved? Rate % body involvment; -9= NA=Not Applicable bio_clinical_18a
Query labsample37 Integer Recommended Minutes in the past week spent doing physical activity that was intense enough to make subject breathe a little bit hard or work up a sweat 0::3000 bio_clinical_19
Query labsample38 Integer Recommended Minutes today spent doing physical activity that was intense enough to make subject breathe a little bit hard or work up a sweat 0::360 bio_clinical_20
Query elig_inclusion_check Integer Recommended Checks for a pass/fail on Elig for Inclusion 0::3 0=Failed (Ineligible); 1=Passed (Eligible); 2=In screening; 3=NA
Query dataquality Integer Recommended Data quality 0::5 0=No data (cancelled); 1=Data entered but only once, has missing data; 2=Data entered but only once, no missing data; 3=Double entered; 4=Data frozen for cleaning; 5=Data clean/locked
Query ibw Float Recommended % IBW (Height age)
Query ideal_bmi Float Recommended % Ideal BMI (50th % for age)
date_updated Date Recommended Date record updated edit_date
Query hdnknc Integer Recommended Head/Neck Not Completed 1=Checked
Query eyesnc Integer Recommended Eyes Not Evaluated 1=Checked
Query earsnc Integer Recommended Ears Not Completed 1=Checked
Query nosenc Integer Recommended Nose/Throat Not Completed 1=Checked
Query cdvsnc Integer Recommended Cardiovascular Not Completed 1=Checked
Query lungnc Integer Recommended Lungs Not Completed 1=Checked
Query abdmnc Integer Recommended Abdomen Not Completed 1=Checked
Query muscnc Integer Recommended Musculoskeletal Not Completed 1=Checked
Query extrnc Integer Recommended Extremities Not Completed 1=Checked
Query skinnc Integer Recommended Skin Not Completed 1=Checked
Query endonc Integer Recommended Endocrine/Diabetes Not Completed 1=Checked
Query neuronc Integer Recommended Neurological Not Completed 1=Checked
Query oth1nc Integer Recommended Other 1 Not Completed 1=Checked
Query oth2nc Integer Recommended Other 2 Not Completed 1=Checked
Query oth3nc Integer Recommended Other 3 Not Completed 1=Checked
Query phex_q09 Integer Recommended Head Result 1::3;-9 1=Normal;2=Abnormal, NOT clinically significant;3=Abnormal, clinically significant;-9=Not Evaluated q09
phex_q10 String 45 Recommended Head Abnormality
Query phex_q21 Integer Recommended Teeth Result 1::3;-9 1=Normal;2=Abnormal, NOT clinically significant;3=Abnormal, clinically significant;-9=Not Evaluated
phex_q22 String 45 Recommended Teeth Abnormality
Query phex_q24 Integer Recommended Neck Result 1::3;-9 1=Normal;2=Abnormal, NOT clinically significant;3=Abnormal, clinically significant;-9=Not Evaluated q30
phex_q25 String 45 Recommended Neck Abnormality
Query phex_q42 Integer Recommended Genitourinary Result 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal; Excludes from Study; 6=Abnormal, Dos Not Exclude from Study; 7=Other; -9=Not Evaluated q66
phex_q43 String 45 Recommended Genitourinary Abnormality
Query visitday Integer Recommended day of visit phex_visitdat_x
weight String 50 Recommended weight -5=item seen but not answered; -999=data not submitted (incomplete) phex_q02
Query q20_3 Integer Recommended Pulse Rate Safety range is 45 to 130. Levels outside of this range will be flagged as an adverse event. Field should not be left blank. If missing, please use -7,-8, -9. phex_q05
Query q19_a3 Integer Recommended Tanner Stage 1 :: 5 1=pre puberty, 2=early puberty, 3=mid puberty, 4=late puberty, 5=post puberty phex_q51, q72
Query pe_4 Integer Recommended Eyes-Ears-Nose-Throat 0::2;-99 1=Normal;2=Abnormal; 0=Not done; -99= Missing Value phys3
pe_4a String 250 Recommended Abnormal Eyes-Ears-Nose-Throat pertinent details text
Query chest_lung String 10 Recommended Chest/lung exam
normal; abnormal; other; not done
pe_5, thorax
pe_5a String 250 Recommended Abnormal Lungs-Chest pertinent details text thorax_comments
Query pe_9 Integer Recommended Cranial Nerves 0::2;-99 1=Normal;2=Abnormal; 0=Not done; -99= Missing Value
pe_9a String 250 Recommended Abnormal Cranial Nerves pertinent details text
Query pe_11 Integer Recommended Sensory System 0::2;-99 1=Normal;2=Abnormal; 0=Not done; -99= Missing Value
pe_11a String 250 Recommended Abnormal Sensory System pertinent details text
Query pe_12 Integer Recommended Reflexes 0::2;-99 1=Normal;2=Abnormal; 0=Not done; -99= Missing Value
pe_12a String 250 Recommended Abnormal Reflexes pertinent details text
Query intrt Integer Recommended Treatment Status Code 0::2 0=Baseline; 1=In Treatment; 2=In Follow-up
Query trtgrp_p Integer Recommended Treatment Group 1;2 1=Long-Acting Injectable Risperidone Microspheres; 2=Second Generation Oral Antipsychotic Medication
Query days_visit1 Integer Recommended Days from Visit 1 dav1pmc
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 visit_number_px, visitnumber
Query phys9 Integer Recommended Allergies 0;1 0 = abnormal 1 = normal
Query study_id Integer Recommended Study ID number 46=Acute Phase; 47=Stabilization Phase
Query week Float Recommended Week in level/study 99=week 10-week 14 intid
Query hair_eval Integer Recommended Evaluation: Hair and Skin
1::3;-9
1=Normal;2=Abnormal, NOT clinically significant;3=Abnormal, clinically significant;-9=Not Evaluated hair
hair_evalsp String 250 Recommended Comments: If Abnormal or Not Evaluated, please provide details below: Hair and Skin hairsp
Query medhxdis String 2 Recommended Has the participant experienced any past and/or concomitant diseases or past surgeries? Y;N Y=Yes; N=No
Query medhxsel String 50 Recommended Concomitant diseases or past surgery: Immunologic; HEENT; Respiratory; Cardiovascular; Gastrointestinal; Neurological; Endocrine/Metabolic; Hepatic; Renal; Oncologic; Musculoskeletal; Surgical History; OB/GYN; Other
medhxdsc String 250 Recommended Medical history event Description meddescr
cmstrtdt Date Recommended Start Date medhxst
strmedend1 Date Recommended What was the end date? medhxent
Query aeongo Integer Recommended Ongoing
0;1
0 = No; 1 = Yes medhxend
comments String 4,000 Recommended Comments about assessment medhxcom
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 ci_enrolled Integer Recommended Participant enrolled 0;1 0=No; 1=Yes enrolled
Query pe_appearclinic Integer Recommended General Appearance Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q08
Query phex_q09_rel Integer Recommended Head Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q11
Query earspe_cr Integer Recommended Ears Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q14
Query eyespe_cr Integer Recommended Eyes Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q17
Query ocular_res Integer Recommended Ocular Fundi Result 1::3 1=Normal, 2=Abnormal, 3=Not Done;Between 1 And 3 Or Is Null;Enter a selection from 1 to 3 q18
Query ocular_cr Integer Recommended Ocular Fundi Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q20
Query nosepe_cr Integer Recommended Nose Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q23
Query pex001a_cr Integer Recommended Mouth Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q26
Query throat_res Integer Recommended Throat Result 1::3 1=Normal, 2=Abnormal, 3=Not Done;Between 1 And 3 Or Is Null;Enter a selection from 1 to 3 q27
Query throat_cr Integer Recommended Throat Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q29
Query phex_q24_cr Integer Recommended Neck Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q32
Query thyroid_res Integer Recommended Thyroid Result 1::3 1=Normal, 2=Abnormal, 3=Not Done;Between 1 And 3 Or Is Null;Enter a selection from 1 to 3 q33
Query thyroid_cr Integer Recommended Thyroid Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q35
Query lung_cr Integer Recommended Lungs Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q38
Query phex_q36_cr Integer Recommended Heart Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q41
Query breasts_res Integer Recommended Breasts Result 1::3 1=Normal, 2=Abnormal, 3=Not Done;Between 1 And 3 Or Is Null;Enter a selection from 1 to 3 q42
Query breasts_cr Integer Recommended Breasts Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q44
Query pex005a_cr Integer Recommended Abdomen Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q47
Query pex010a_cr Integer Recommended Musculoskeletal Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q50
Query extrem_cr Integer Recommended Extremities Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q53
Query skinn_cr Integer Recommended Skin Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q56
Query pex009a_cr Integer Recommended Lymph Nodes Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q59
Query pulse_res Integer Recommended Pulses Result 1::3 1=Normal, 2=Abnormal, 3=Not Done;Between 1 And 3 Or Is Null;Enter a selection from 1 to 3 q60
Query pulse_cr Integer Recommended Pulses Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q62
Query neurope_cr Integer Recommended Neurological Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q65
Query phex_q42_cr Integer Recommended Genitourinary Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q68
Query rec_cr Integer Recommended Rectal Clinically Relevant 1::4;9 1=Yes, Excludes; 2=Yes, does not exclude; 3=No, not relevant; 4=Unknown;Between 1 And 3 Or 9 Or Is Null;Enter 1, 2, 3 or 9 q71
Query waist Float Recommended 5. Waist inches waist_circumference
Query bmi Float Recommended body mass index of subject -9 = Missing
arith_temperature_ct String 50 Recommended Temperature temperature
bp String 25 Recommended Blood Pressure bloodpressure
Query pulse Float Recommended Pulse
Query med_change String 5 Recommended Any change in medication? Yes; No Since week (-2)
med_change_notes String 250 Recommended What medication changes?
Query subjecttype String 20 Recommended Subject Type Control;Prodromal; Enhanced; Non-Enhanced
Query rand_num Integer Recommended Randomization Number 0::2
Query pe_ncat String 2 Recommended Physical Exam: Normocephalic Atraumatic (NCAT) N; Y; NE N = Not Within Normal Limits; Y = Yes Within Normal Limits; NE = Not Examined
pe_ncatabn String 255 Recommended Physical Exam: Normocephalic Atraumatic (NCAT): Description of Abnormality
pe_fundiabn String 255 Recommended Physical Exam: Ocular Funduscopic (FUNDI): Description of Abnormality
Query pe_tms String 2 Recommended Physical Exam: Tympanic Membrane (TM) N; Y; NE N = Not Within Normal Limits; Y = Yes Within Normal Limits; NE = Not Examined
pe_tmsabn String 255 Recommended Physical Exam: Tympanic Membrane (TM): Description of Abnormality
pe_thyroidabn String 255 Recommended Physical Exam: Thyroid: Description of Abnormality
Query suq12c1 Integer Recommended Has subject ever smoked on a pretty regular basis? 1;2; -99; 77; 88 1=No; 2=Yes; -99=NA; 77=refused; 88=missing
Query sm_2j Integer Recommended Are you currently a daily cigarette smoker? 1;2; 999; 77 1=No; 2=Yes; 999=DK; 77=Refused
Query smq4 Integer Recommended Have many cigarettes do you typically smoke each day? 1::6 1 = Zero; 2 = 1 to 5; 3 = 6 to 10; 4 = 11 to 15 ;5 = 16 to 20; 6 = Over 20
Query caf_month Integer Recommended how many days per month do you consume caffeinated beverages 0::31; 999; 77 999=DK; 77=Refused
Query aescode Integer Recommended Staff code number of person completing this form 999= Missing Data
Query cdcaf Float Recommended caffeine cups per day 999=DK; 77=Refused
Query pex002a_css Integer Recommended Evaluation: HEENT (including thyroid/neck) - Change Since Screening? 0;1 0=No;1=Yes
Query hdnkpe_css Integer Recommended Evaluation: Head/Neck PE Results - Change Since Screening? 0;1 0=No;1=Yes
Query pex003a_css Integer Recommended Evaluation: Cardiovascular - Change Since Screening? 0;1 0=No;1=Yes
Query pex004a_css Integer Recommended Evaluation: Lungs - Change Since Screening? 0;1 0=No;1=Yes
Query pex005a_css Integer Recommended Evaluation: Abdomen (including liver, spleen) - Change Since Screening? 0;1 0=No;1=Yes
Query pex007a_css Integer Recommended Evaluation: Skin - Change Since Screening? 0;1 0=No;1=Yes
Query pex006a_css Integer Recommended Evaluation: Extremities - Change Since Screening? 0;1 0=No;1=Yes
Query neurope_css Integer Recommended Evaluation: Neurological Results - Change Since Screening? 0;1 0=No;1=Yes
Query breasts_res_css Integer Recommended Breasts Result - Change Since Screening? 0;1 0=No;1=Yes
Query chest_lung_css Integer Recommended Chest/lung exam - Change Since Screening? 0;1 0=No;1=Yes
Query pex010a_css Integer Recommended Evaluation: Musculoskeletal - Change Since Screening? 0;1 0=No;1=Yes
Query rec_css Integer Recommended Evaluation: Rectal - Change Since Screening? 0;1 0=No;1=Yes
Query genit_css Integer Recommended Evaluation: Genital/Pelvic - Change Since Screening? 0;1 0=No;1=Yes
wk_mammogram_com String 250 Recommended Mammogram. Comments
Query physex23 Integer Recommended 11. Neurological: Balance 1; 2; -9 1=Normal; 2=Abnormal; -9=not evaluated
physex24 String 100 Recommended 11. Neurological: Balance. Describe any abnormalities
Query me2 Integer Recommended Status 0;1 0 = Past [Inactive]; 1 = Active
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 nervous_system Integer Recommended Nervous System 1;2 1= Normal; 2= Abnormal
nervous_sys_comments String 50 Recommended Nervous System Comments
examdate Date Recommended Date of last medical exam? mhpe_date
pe55 Integer Recommended Do you want to follow genetial/pelvic conditionas a pre-existing AE? 1;2 1= Yes; 2= No
pe6 Integer Recommended Do you want to follow HEENT condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe12 Integer Recommended Do you want to follow lung condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe43 Integer Recommended Do you want to follow lymph node condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe27 Integer Recommended Do you want to follow motor strength as a pre-existing AE? 1;2 1= Yes; 2= No
pe46 Integer Recommended Do you want to follow musculoskeletal condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe3 Integer Recommended Do you want to follow oral condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe59 Integer Recommended Do you want to follow other condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe40 Integer Recommended Do you want to follow other neurological condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe52 Integer Recommended Do you want to follow rectal condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe30 Integer Recommended Do you want to follow reflex condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe36 Integer Recommended Do you want to follow sensory exam as a pre-existing AE? 1;2 1= Yes; 2= No
pe21 Integer Recommended Do you want to follow skin condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe31 Integer Recommended Coordination and gait 1::6;-9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal Excludes; 6=Abnormal Does not Exclude; -9=Not Evaluated
pe15 Integer Recommended Do you want to follow abdomen condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe9 Integer Recommended Do you want to follow cardiovascular condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe33 Integer Recommended Do you want to follow coordination condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe24 Integer Recommended Do you want to follow cranial nerves as a pre-existing AE? 1;2 1= Yes; 2= No
pe18 Integer Recommended Do you want to follow extremity condition as a pre-existing AE? 1;2 1= Yes; 2= No
pe49 Integer Recommended Do you want to follow general appearance as a pre-existing AE? 1;2 1= Yes; 2= No
ent Integer Recommended Ears, nose, throat physical exam results 1::2 1=normal; 2=abnormal
eyes1 Integer Recommended Eyes: Physical Exam Results 1;2 1 = Normal ; 2 = Abnormal
q19_a1a Integer Recommended Height: Feet 2 :: 9; -5::-2;-9::-7;-999 Number of feet; -2= Not collected at this time point; -3= Historical missing; -4= Not collected; -5=item seen but not answered; if missing, please use -7, -8, -9; -999=data not submitted (incomplete)
q19_a1b Integer Recommended Height: Inches 0 :: 85; -7; -8; -9 Round to the nearest ¼ in. Field should not be left blank. If missing, please use -7,-8, -9.
cardio_respratecount String 50 Recommended Respiratory Rate - Count
pne_eligcmts String 4,000 Recommended Comments regarding eligibility based on physical and neurological exam
pne_refer Integer Recommended Any medical history, physical, and/or neurological exam abnormalities referred for further eval or treatment? 0;1 0 = No; 1 = Yes
pne_refercmts String 4,000 Recommended Comments on referral for abnormalities in medical history, physical or neuro exam
nedis Integer Recommended Discharge Neurological Exaxm 0::2 0 = Within Normal Limits; 1 = Abnormal Not Clinically Significant; 2 = Abnormal Clinically Significant
nedis_change Integer Recommended Are discharge neurological exam abnormalities a change from screening neurological exam? 0;1 0 = No; 1 = Yes
nedis_ncsabnorm String 280 Recommended Comments on changes in clinically INSIGNIFICANT neurological exam abnormalities
nedis_csabnorm String 280 Recommended Comments on changes in clinically SIGNIFICANT neurological exam abnormalities
pe_abnorm Integer Recommended Any other focused physical exam abnormalities? 0;1 0 = No; 1 = Yes
pe_abnormcmts String 280 Recommended Comments on other focused physical exam abnormalities
ne_discharge Integer Recommended Safe for discharge? 0;1 0 = No; 1 = Yes
ne_dischargecmts String 280 Recommended Comments and actions taken if not safe for discharge
nedis_refer Integer Recommended Any neurological or focused physical exam abnormalities referred for further evaluation or treatment? 0;1 0 = No; 1 = Yes
nedis_refercmts String 280 Recommended Comments on neurological or focused physical exam abnormalities referred
medhx_elig Integer Recommended Eligibility based on medical history 0::2 0 = Pending; 1 = Eligible; 2 = Disqualifying
medhx_disqual Integer Recommended Reasons for disqualification based on medical history 1::12 1 = Disqualifying Medical Condition; 2 = On Medications That Could Affect Study Outcomes; 3 = Moderate or Severe TBI; 4 = Diagnosis of Sleep Apnea; 5 = Not Willing to Stop Using Alcohol for 2 weeks; 6 = Not willing to Stop Using Nicotine = Marijuana or Illicit Drugs for 4 weeks; 7 = Unable to Tolerate IV Placement or Blood Drawing by Needle Stick; 8 = Allergy to Ingredients in IV Allopregnanolone or Placebo drug formulation including excipient;9 = Oral Contraceptives or Use of Systemic Hormone Therapy (except hormonal IUD; will need to determine ovulation); 10 = If Biologically Female: Unnatural and/or irregular menstrual cycle; 11 = If Biologically Female: Not Willing to Use 2 Types of Allowable Effective Forms of Birth Control; 12 = If Biologically Female: Breastfeeding
medhx_eligcmts String 4,000 Recommended Comments regarding eligibility based on medical history
pne Integer Recommended Physical and neurological exam 0::2 0 = Within normal limits; 1 = Abnormal not clinically significant; 2 = Abnormal clinically significant
pne_ncsabnorm String 4,000 Recommended Comments on clinically INSIGNIFICANT physical and neurological exam abnormalities
pne_csabnorm String 280 Recommended Comments on clinically SIGNIFICANT physical and neurological exam abnormalities
pne_elig Integer Recommended Eligibility based on physical and neurological exam 0::2 0 = Pending; 1 = Eligible; 2 = Disqualifying
pe_palm Integer Recommended Palmar erythema 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_contract Integer Recommended Contractures 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_spider Integer Recommended Spider angiomata 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_aster Integer Recommended Asterixiz 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_hepat Integer Recommended Hepatic Encephalopathy 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_wast Integer Recommended Wasting 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_fetor Integer Recommended Fetor 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_prurit Integer Recommended Pruritus 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_ascit Integer Recommended Ascites 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_obese Integer Recommended Obese 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_splen Integer Recommended Splenomegaly 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_hepmeg Integer Recommended Hepatomegaly 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_const Integer Recommended Constitutional symptoms 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_ears Integer Recommended Ear, Nose, Mouth, Throat 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_resp Integer Recommended Respiratory (Lungs/Chest) 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_gastro Integer Recommended Gastrointestinal 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_hemato Integer Recommended Hematologic/Lymphatic 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_allergic Integer Recommended Allergic/Immunologic 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
pe_jaun Integer Recommended Jaundice 1::7; -9 1=Normal; 2=Abnormal, NOT clinically significant; 3=Abnormal, clinically significant; 4=Abnormal; 5=Abnormal, Excludes from Study; 6=Abnormal, Does Not Exclude from Study; 7=Other; -9=Not Evaluated
ent_abnormal String 100 Recommended Describe Abnormality (ENT)
ent_signif Integer Recommended Is abnormality clinically significant (ENT) 0;1 0=Not clinically significant; 1=Clinically significant
hnt_result Integer Recommended Result (HNT) 0::2 0=Normal;1=Abnormal;2=Not examined
hnt_abnormal String 100 Recommended Describe Abnormality (HNT)
hnt_signif Integer Recommended Is abnormality clinically significant (HNT) 0;1 0=Not clinically significant; 1=Clinically significant
car_result Integer Recommended Result (cardiovascular) 0::2 0=Normal;1=Abnormal;2=Not examined
car_abnormal String 100 Recommended Describe Abnormality (cardiovascular)
car_signif Integer Recommended Is abnormality clinically significant (cardiovascular) 0;1 0=Not clinically significant; 1=Clinically significant
lc_result Integer Recommended Result (lungs and chest) 0::2 0=Normal;1=Abnormal;2=Not examined
lc_abnormal String 100 Recommended Describe Abnormality (lungs and chest)
lc_signif Integer Recommended Is abnormality clinically significant (lungs and chest) 0;1 0=Not clinically significant; 1=Clinically significant
abd_result Integer Recommended Result (abdomen) 0::2 0=Normal;1=Abnormal;2=Not examined
abd_abnormal String 100 Recommended Describe Abnormality (abdomen)
abd_signif Integer Recommended Is abnormality clinically significant (abdomen) 0;1 0=Not clinically significant; 1=Clinically significant
gu_result Integer Recommended Result (genitourinary) 0::2 0=Normal;1=Abnormal;2=Not examined
gu_abnormal String 100 Recommended Describe Abnormality (genitourinary)
gu_signif Integer Recommended Is abnormality clinically significant (genitourinary) 0;1 0=Not clinically significant; 1=Clinically significant
ext_result Integer Recommended Result (extremities) 0::2 0=Normal;1=Abnormal;2=Not examined
ext_abnormal String 100 Recommended Describe Abnormality (extremities)
ext_signif Integer Recommended Is abnormality clinically significant (extremities) 0;1 0=Not clinically significant; 1=Clinically significant
app_result Integer Recommended Result (appearance) 0::2 0=Normal;1=Abnormal;2=Not examined
mus_result Integer Recommended Result (musculoskeletal) 0::2 0=Normal;1=Abnormal;2=Not examined
mus_abnormal String 100 Recommended Describe Abnormality (musculoskeletal)
mus_signif Integer Recommended Is abnormality clinically significant (musculoskeletal) 0;1 0=Not clinically significant; 1=Clinically significant
other Integer Recommended Other prevent dose increase 0;1;999 0 = No; 1 = Yes
otherresult Integer Recommended Result (other body system) 0::2 0=Normal;1=Abnormal;2=Not examined
otherdesc String 100 Recommended Describe Abnormality (other body system)
othersig Integer Recommended Is Abnormality Clinically Significant? (other body system) 0;1 0=Not clinically significant; 1=Clinically significant
app_abnormal String 100 Recommended Describe Abnormality (appearance)
app_signif Integer Recommended Is abnormality clinically significant (appearance) 0;1 0=Not clinically significant; 1=Clinically significant
sk_result Integer Recommended Result (skin) 0::2 0=Normal;1=Abnormal;2=Not examined
sk_abnormal String 100 Recommended Describe Abnormality (skin)
sk_signif Integer Recommended Is abnormality clinically significant (skin) 0;1 0=Not clinically significant; 1=Clinically significant
ent_result Integer Recommended Result (ENT) 0::2 0=Normal;1=Abnormal;2=Not examined
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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