|
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 :: 1260
|
Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
|
hrbpage, htwtage, intvage |
|
sex |
String |
20
|
Required |
Sex of subject at birth |
|
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 = 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 = 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=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=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=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=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=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=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=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 |
|
|
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=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 = 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
|
|