|
subjectkey |
GUID |
|
Required |
The NDAR Global Unique Identifier (GUID) for research subject |
NDAR*
|
|
|
|
src_subject_id |
String |
20
|
Required |
Subject ID how it's defined in lab/project |
|
|
subject |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
|
|
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.
|
|
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
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 |
Query
|
aescode |
Integer |
|
Recommended |
Staff code number of person completing this form |
|
999= Missing Data
|
clinician |
|
thrpy_start1 |
Date |
|
Recommended |
Therapy 1 start date |
|
|
sedate |
Query
|
bafinfo |
Integer |
|
Recommended |
Check if the Assessment was not done. |
|
0=No; 1=Yes; 2=Unverified
|
seinfo |
|
meau_01b |
Date |
|
Recommended |
When was the first day of your last menstrual period? |
|
|
lstper |
|
vis4b1 |
String |
55
|
Recommended |
Medical Procedure 1 |
|
|
medpro |
|
enroll_notes |
String |
200
|
Recommended |
Notes about enrollment status |
|
|
enrvisnote |
|
p_meds_4 |
String |
1,500
|
Recommended |
List any medications |
|
Name of medication (space) Dosage (space) Frequency (space) Total Daily Dosage ex: Xanax 25mg 2xday (or as needed)
|
nwmedl |
Query
|
ghq_2 |
Integer |
|
Recommended |
Current smoker. How many cigarettes per day? |
1 :: 200
|
|
cign |
Query
|
scq_07 |
Integer |
|
Recommended |
Liver Disease |
|
0=No; 1=Yes
|
livd |
Query
|
htchs |
Integer |
|
Recommended |
Heart: Chest pain |
|
0=No; 1=Yes
|
chstp |
Query
|
medprob_pulmbreath |
String |
50
|
Recommended |
If Yes, Was the abnormality Shortness of breath |
Yes;No
|
|
sbrth |
Query
|
wk_seizure |
Integer |
|
Recommended |
40. Seizure |
|
No = 0; Yes = 1;
|
sez |
Query
|
baseline_k_005 |
Integer |
|
Recommended |
Has she/he ever been to a doctor for any of these things…Diabetes /Diabetes |
|
0=No; 1=Yes; -888=Not Applicable; -999=Missing/NK; -7=Refused //Now I'd like to ask you about your child's use of health services during the past year and throughout his/her whole life.
|
diab |
Query
|
fi89 |
Integer |
|
Recommended |
89. Are you troubled by headaches? |
|
0 = No; 1 = Yes; 97 = Refused; 98 = Don't know; 99 = NA
|
uhdach |
Query
|
child_migraine |
String |
50
|
Recommended |
Does the Child have Migraine Headaches? |
Yes;No;999
|
999=NA/missing
|
migrhd |
Query
|
midihist_019 |
Integer |
|
Recommended |
Hyperlipidemia/hypertriglyceridemia |
|
1=No History; 2=Yes; 9=Not evaluated; -999= Don't know/Missing Data
|
trigly |
Query
|
bas_10 |
Integer |
|
Recommended |
Do you have high blood pressure? |
|
1= Yes; 2= No; 999= No Answer; 888= Skipped; 777= Condition Skipped; 555= Missing
|
hyprt |
Query
|
brestend |
Integer |
|
Recommended |
breast tenderness |
|
0=No; 1=Yes; -7=Refused
|
brtnd |
Query
|
lifeline_023_10 |
Integer |
|
Recommended |
Mental/Emotional State (choice=Mood Changes) |
|
0=Unchecked; 1=Checked; -888=Not Applicable; -999=Missing
|
mood |
Query
|
dawba_m1_l |
Integer |
|
Recommended |
Areas of Difficulty - Other Concerns |
|
0 = No; 1 = Yes
|
othr |
|
dawba_m2_l4 |
String |
255
|
Recommended |
Description - Other Concerns - Other things you are concerned about |
|
|
othrsp |
Query
|
height |
Float |
|
Recommended |
Medical history and physical development - Height (inches) |
|
inches
|
|
Query
|
q53_a3a |
Integer |
|
Recommended |
Weight lbs |
-7;-8;-9; 20 :: 400
|
Field should not be left blank. If missing, please use -7,8, -9.
|
weight |
Query
|
v1_avs_1st_systolic |
Integer |
|
Recommended |
First Reading Systolic BP (mmHg) |
|
|
sbp1 |
Query
|
v1_avs_1st_diastolic |
Integer |
|
Recommended |
First Reading Diastolic BP (mmHg) |
|
|
dbp1 |
Query
|
v1_avs_2ndt_systolic |
Integer |
|
Recommended |
Second Reading Systolic BP (mmHg) |
|
|
sbp2 |
Query
|
v1_avs_2nd_diastolic |
Integer |
|
Recommended |
Second Reading Diastolic BP (mmHg) |
|
|
dbp2 |
Query
|
v1_avs_3rd_systolic |
Integer |
|
Recommended |
Third Reading Systolic BP (mmHg) |
|
|
sbp3 |
Query
|
v1_avs_3rd_diastolic |
Integer |
|
Recommended |
Third Reading Diastolic BP (mmHg) |
|
|
dbp3 |
Query
|
v1_avs_average_sysbp |
Integer |
|
Recommended |
Average Systolic Blood Pressure (mmHg) |
|
|
sbpavg |
Query
|
v1_avs_average_diasbp |
Integer |
|
Recommended |
Average Diastolic Blood Pressure (mmHg) |
|
|
dbpavg |
|
adis_other |
String |
200
|
Recommended |
Do you have any other concerns or Questionss about today's interview or about your upcoming appointments? |
|
|
addlq |
Query
|
bmibycalc |
Float |
|
Recommended |
BMI by calculation |
|
|
bmi |
Query
|
bld |
Integer |
|
Recommended |
Bleeding side effect: None/No flow |
|
0 = No; 1 = Yes
|
|
Query
|
febld |
Integer |
|
Recommended |
First or only episode of bleeding |
|
0 = No; 1 = Yes
|
|
Query
|
proyr |
Integer |
|
Recommended |
Year of Procedure(Screening visit only) |
|
|
|
Query
|
bldsp |
Integer |
|
Recommended |
Bleeding side effect: Spotting |
|
0 = No; 1 = Yes
|
|
Query
|
bldspd |
Integer |
|
Recommended |
Bleeding symptom frequency |
1::3
|
1=Only for a few days, 2=On and off throughout, but not for more than 14 days, 3=[ ] days in a row
|
bldmdd, bldmld |
Query
|
bldspdr |
Integer |
|
Recommended |
Spotting: number of days in a row |
|
|
|
|
bldspsd |
Date |
|
Recommended |
Bleeding start date |
|
|
bldmdsd, bldmlsd, bldpbbsd, bldpbsd |
|
bldsped |
Date |
|
Recommended |
Bleeding end date |
|
|
bldmded, bldmled, bldpbbed, bldpbed |
Query
|
bldml |
Integer |
|
Recommended |
Bleeding side effect;Mild bleeding |
|
0 = No; 1 = Yes
|
|
Query
|
bldmd |
Integer |
|
Recommended |
Bleeding side effect;moderate bleeding |
|
0 = No; 1 = Yes
|
|
Query
|
bldpb |
Integer |
|
Recommended |
Bleeding side effect;Prolonged Bleeding |
|
0 = No; 1 = Yes
|
|
|
bldpbd |
Date |
|
Recommended |
Date prolonged bleeding reviewed with PI |
|
|
|
Query
|
bldpbb |
Integer |
|
Recommended |
Bleeding side effect;Profuse Breakthrough Bleeding |
|
0 = No; 1 = Yes
|
|
Query
|
bldpbbfr |
Integer |
|
Recommended |
If profuse breakthrough bleeding, select option: |
1;2
|
1=More than 1 tampon or pad per hour on any one day, 2=more than 3 tampons or pads per day for more than 3 days
|
|
|
bldpbbd |
Date |
|
Recommended |
Date profuse bleeding reviewed with PI |
|
|
|
Query
|
bldo |
Integer |
|
Recommended |
Bleeding Other |
|
0 = No; 1 = Yes
|
|
|
bldoth |
String |
500
|
Recommended |
Specify other bleeding situation |
|
|
|
Query
|
bldadeps |
Integer |
|
Recommended |
Check here if additional episodes of bleeding |
|
0 = No; 1 = Yes
|
|
|
othrsymp |
String |
1,000
|
Recommended |
Have you been expereiceing any other symptoms of menopause, such as hot flashes, sleep disturbances or mood changes? |
|
|
|
Query
|
nwmed |
Integer |
|
Recommended |
Check here if Started new medications or supplements that you were not on before the study started. |
|
0 = No; 1 = Yes
|
|
Query
|
cig |
Integer |
|
Recommended |
Started to smoke cigarettes or have you changed the number cigarettes you typically smoke in a
day? |
|
0 = No; 1 = Yes
|
|
Query
|
gainwt |
Integer |
|
Recommended |
Gained more than 2 pounds of weight |
|
0 = No; 1 = Yes
|
|
Query
|
pnleg |
Integer |
|
Recommended |
Had pain in your legs or tenderness behind one or both of your knees or calves |
|
0 = No; 1 = Yes
|
|
Query
|
swl |
Integer |
|
Recommended |
Developed swelling in one or both of your legs or feet |
|
0 = No; 1 = Yes
|
|
Query
|
prg |
Integer |
|
Recommended |
Become pregnant or concerned that you may be pregnant |
|
0 = No; 1 = Yes
|
|
Query
|
naus |
Integer |
|
Recommended |
Had much more nausea than you had before the study started. |
|
0 = No; 1 = Yes
|
|
Query
|
hdach |
Integer |
|
Recommended |
Started to have migraine headaches or have your usual headaches become worse (if yes, check which all that apply) |
|
0 = No; 1 = Yes
|
|
|
migrhdd |
Date |
|
Recommended |
Migraine reviewed with PI date |
|
|
|
Query
|
migrahd |
Integer |
|
Recommended |
Migraine with aura |
|
0 = No; 1 = Yes
|
|
|
migrahdd |
Date |
|
Recommended |
Migraine with aura reviewed with PI date |
|
|
|
Query
|
vsplb |
Integer |
|
Recommended |
Had changes in your vision or problems with your corrective lenses? |
|
0 = No; 1 = Yes
|
|
Query
|
throm |
Integer |
|
Recommended |
Developed a clotting problem where the blood in your veins clots too easily. (The medical term for this is "Thrombophilia"). |
|
0 = No; 1 = Yes
|
|
Query
|
mammg |
Integer |
|
Recommended |
Had a mammogram (the X-ray test that looks for breast cancer) that is concerning or abnormal. |
|
0 = No; 1 = Yes
|
|
Query
|
hvbleed |
Integer |
|
Recommended |
Had very heavy vaginal beeding (i.e., more than that which you typically experieced during menses prior to the start of this study) |
|
0 = No; 1 = Yes
|
|
Query
|
brlmp |
Integer |
|
Recommended |
Noticed any concerning breast lumps? |
|
0 = No; 1 = Yes
|
|
Query
|
sbp4 |
Integer |
|
Recommended |
Reading 4: Systolic Blood Pressure (SBP) |
|
|
|
Query
|
dbp4 |
Integer |
|
Recommended |
Reading 4: Diastolic Blood Pressure (DBP) |
|
|
|
Query
|
hyperi |
Integer |
|
Recommended |
Subject is hypertensive, stage I? (Flags as AE) |
|
0 = No; 1 = Yes
|
|
Query
|
hyperii |
Integer |
|
Recommended |
Subject is hypertensive, stage II? (Triggers drop-out) |
|
0 = No; 1 = Yes
|
|
Query
|
maintdose |
Integer |
|
Recommended |
Maintenance dose changed to : 0=Unchanged, 1=0.025 mg, 2=0.05 mg, 3=.1 mg |
0::3
|
0=Unchanged, 1=0.025 mg, 2=0.05 mg, 3=.1 mg
|
|
Query
|
earlypatch |
Integer |
|
Recommended |
How many patches came off early? |
|
|
|
Query
|
dashdiet |
Integer |
|
Recommended |
Have you considered/adhered to the DASH diet? |
|
0 = No; 1 = Yes
|
|
Query
|
physguid |
Integer |
|
Recommended |
Have you considered/adhered to the physical activity guidelines? |
|
0 = No; 1 = Yes
|
|
Query
|
brstexm |
Integer |
|
Recommended |
Have you considered doing/done breast exams? |
|
0 = No; 1 = Yes
|
|
Query
|
wearpatch |
Integer |
|
Recommended |
Are you wearing your patch? |
|
0 = No; 1 = Yes
|
|