|
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 |
|
|
case_id, id, randid, subject_id, subjectid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
intvdate, visit_date |
|
interview_age |
Integer |
|
Required |
Age in months at the time of the interview/test/sampling/imaging. |
0::1440
|
Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
|
bslage, intvage |
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
Query
|
se_relationship |
Integer |
|
Recommended |
Relationship to Child: |
1::9
|
1= Mother; 2= Grandmother; 3= Guardian, female; 4= Other female; 5= Father; 6= Grandfather; 7= Guardian, male; 8= Other male; 9= Other
|
aer00a, rel |
Query
|
se_a1 |
Integer |
|
Recommended |
1. Current health complaints |
1;2; -9
|
1 = Yes; 2 = No; -9 =unknown
|
aer001, currhlth, hbr001, seg_q32, sem_q32 |
Query
|
se_a2 |
Integer |
|
Recommended |
2. Recent injuries, illness requiring medical attention |
1;2; -9
|
1 = Yes; 2 = No; -9 =unknown
|
aer002, hbr002, recinjur, seg_q33, sem_q33 |
Query
|
se_a3 |
Integer |
|
Recommended |
3. Recent illness |
1;2
|
1 = Yes; 2 = No
|
recill, seg_q34, sem_q34 |
Query
|
se_a4 |
Integer |
|
Required |
4. Concurrent medication |
1;2;999
|
1 = Yes; 2 = No
|
aer004, conmed, seg_q35, sem_q35 |
Query
|
se_b1 |
Integer |
|
Recommended |
Irritable, easily annoyed, touchy, (emotionally over-reactive) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done; -9=unknown
|
hbr028a, sem_q01 |
Query
|
se_b2 |
Integer |
|
Recommended |
2. Crabby, whiny |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
se8, sem_q02 |
Query
|
se_b3 |
Integer |
|
Recommended |
3. Tearful, prone to crying |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
sem_q03 |
Query
|
se_b4 |
Integer |
|
Recommended |
Sad, unhappy, depressed |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
aer031a, hbr030a, se9, sem_q04 |
Query
|
se_b5 |
Integer |
|
Recommended |
5. Social withdrawal, talks or interacts little |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
se10, sem_q05 |
Query
|
se_b6 |
Integer |
|
Recommended |
6. Staring, daydreaming |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
sem_q06 |
Query
|
se_b7 |
Integer |
|
Recommended |
7. Dull, not alert |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
se5, sem_q07 |
Query
|
se_b8 |
Integer |
|
Recommended |
8. Drowsy, sleepy |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done; -9=unknown
|
aer006a, drowsiness, hbr005a, sem_q08 |
Query
|
se_b9 |
Integer |
|
Recommended |
9. Insomnia (parents only to respond) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
aer027a, hbr026a, insomnia, se13, sem_q09 |
Query
|
se_b10 |
Integer |
|
Recommended |
10. Nightmares (parents only to respond) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
sem_q10 |
Query
|
se_b11 |
Integer |
|
Recommended |
11. Eating less or skipping meals |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
anorexia, se12, sefgass7, sem_q11 |
Query
|
se_b12 |
Integer |
|
Recommended |
12. Diarrhea, loose bowel movements |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done; -9=unknown
|
diarrhea, safte32, se_q11, sefgass12, sem_q12, sft034 |
Query
|
se_b13 |
Integer |
|
Recommended |
13. Encopresis (soiling of self not due to diarrhea) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
sem_q13 |
Query
|
se_b14 |
Integer |
|
Recommended |
14. Bed or pants wetting |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
sem_q14 |
Query
|
se_b15 |
Integer |
|
Recommended |
15. Dizzy, balance unstable |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done; -9=unknown
|
aer018a, hbr017a, safte13, se_q09, sem_q15 |
Query
|
se_b16 |
Integer |
|
Recommended |
16. Headaches |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr012a, headache, se6, se_q08, sem_q16, sft016 |
Query
|
se_b17 |
Integer |
|
Recommended |
17. Stomachaches, nausea, vomiting |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
safte29, se7, sem_q17 |
Query
|
se_b18 |
Integer |
|
Recommended |
18. Anxiety, fear, nervousness |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done; -9=unknown
|
aer012a, hbr011a, safte04, se4, se_q14, sem_q18 |
Query
|
se_b19 |
Integer |
|
Recommended |
19. Restless, high activity level |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
sem_q19 |
Query
|
se_b20 |
Integer |
|
Recommended |
20. Easily excited |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
sem_q20 |
Query
|
se_b21 |
Integer |
|
Recommended |
21. Excessive talking |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
aer033a, hbr032a, sem_q21 |
Query
|
se_b22 |
Integer |
|
Recommended |
22. Excessively happy, silly |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
aer034a, hbr033a, sem_q22 |
Query
|
se_b23 |
Integer |
|
Recommended |
23. Bizarre behavior |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
sem_q23 |
Query
|
se_b24 |
Integer |
|
Recommended |
24. Repetitive tongue movements |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
sem_q24 |
Query
|
se_b25 |
Integer |
|
Recommended |
25. Muscle twitches or sudden sounds |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done; -9=unknown
|
safte21, sem_q25, sft023 |
Query
|
se_b26 |
Integer |
|
Recommended |
26. Gets stuck on repetitive activities |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
sem_q26 |
Query
|
se_b27 |
Integer |
|
Recommended |
27. Stereotypic movements (deliberate, repetitive movements with no apparent function: e.g., rocks body back and forth; shakes hand(s) in front of eyes) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
sem_q27 |
Query
|
se_b28 |
Integer |
|
Recommended |
28. Self injury (deliberately hurts self ? e.g., bites, hits, scratches, or otherwise injures self) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
sem_q28 |
Query
|
se_b29 |
Integer |
|
Recommended |
29. Repetitive picking at hair, skin, fingernails or biting fingernails |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
se3, sem_q29 |
Query
|
se_bother1 |
Integer |
|
Recommended |
Other |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
other, se_q29, sem_q30 |
Query
|
se_bother1s |
String |
250
|
Recommended |
Specify |
|
|
|
Query
|
se_bother2 |
Integer |
|
Recommended |
Other |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
sem_q31 |
|
se_bother2s |
String |
250
|
Recommended |
Specify |
|
|
|
|
comments_misc |
String |
4,000
|
Recommended |
Miscellaneous comments on study, interview, methodology relevant to this form data |
|
|
SE_comments, sft049 |
|
level |
String |
10
|
Recommended |
Treatment level |
|
|
|
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
|
Query
|
hand_date |
Integer |
|
Recommended |
reported date |
|
|
date |
Query
|
vis_type |
Integer |
|
Recommended |
Visit type |
0::2
|
1=Phone/remote; 0=doctor's office/In person; 2=No, not phone interview
|
phone |
Query
|
lang_visit |
Integer |
|
Recommended |
Language during visit |
0;1
|
1=Spanish; 0=English
|
spanish |
Query
|
fisfq |
Integer |
|
Recommended |
Side effect frequency |
0::6
|
0=No side effects; 1=Present 10 percent of the time; 2=Present 25 percent of the time; 3=Present 50 percent of the time; 4=Present 75 percent of the time; 5=Present 90 percent of the time; 6=Present all the time
|
|
Query
|
fisin |
Integer |
|
Recommended |
Side effect intensity |
0::6
|
0=No side effects; 1=Trivial; 2=Mild; 3=Moderate; 4=Marked; 5=Severe; 6=Intolerable
|
|
Query
|
grseb |
Integer |
|
Recommended |
Side effect burden |
0::6
|
0=No burden; 1=Minimal; 2=Mild; 3=Moderate; 4=Marked; 5=Severe; 6=Unable to function due to side effects
|
|
Query
|
days_baseline |
Integer |
|
Recommended |
Days since baseline |
|
|
bsldays, dayse |
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)
|
assse |
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
|
actse |
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
sit_uid, site_no, siteid, sitenum |
Query
|
sjtyp |
Integer |
|
Recommended |
Subject type |
1;2
|
1=MTA randomized trial subject; 2=Local normative comparison group (LNCG) subject
|
|
Query
|
se1 |
Integer |
|
Recommended |
Motor Tics - sudden, involuntary simple jerks or movements such as forceful eye blinking, eye opening, a rapid head jerk to one side,; or more complex facial gestures or shoulder movements/shrugs |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
se2 |
Integer |
|
Recommended |
Buccal-lingual movements - Tongue thrusts, jaw clenching, chewing movements besideslip/cheek biting |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
se11 |
Integer |
|
Recommended |
Hallucinations |
0::4
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; 4=not done
|
safte10, sft013 |
Query
|
sep |
Integer |
|
Recommended |
Number of items rated 2, 3, or 4 |
|
|
|
Query
|
sem |
Integer |
|
Recommended |
Number of items rated 3 or 4 |
|
|
|
Query
|
se14 |
Integer |
|
Recommended |
Does the adolescent take meds for ADHD? And/or for attention, behavior, mood, and emotions |
0;1
|
0=No; 1=Yes
|
|
Query
|
medication1_name |
String |
500
|
Recommended |
Name first medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
se14n1 |
Query
|
se14t1 |
Integer |
|
Recommended |
Times taken per day med 1 |
|
|
|
|
medication1_dosage |
String |
150
|
Recommended |
First medication dosage |
|
0 = No medication; 999 = Missing
|
se14mg11 |
Query
|
se14sl11 |
Integer |
|
Recommended |
Dose 1 Short acting or long acting med 1 |
1;2
|
1=Short acting; 2=Long acting
|
|
Query
|
se14mg12 |
Float |
|
Recommended |
Dose 2 med 1 |
|
|
|
Query
|
se14sl12 |
Integer |
|
Recommended |
Dose 2 Short acting or long acting med 1 |
1;2
|
1=Short acting; 2=Long acting
|
|
Query
|
se14mg13 |
Float |
|
Recommended |
Dose 3 med 1 |
|
|
|
Query
|
se14sl13 |
Integer |
|
Recommended |
Dose 3 Short acting or long acting med 1 |
1;2
|
1=Short acting; 2=Long acting
|
|
Query
|
se14mg14 |
Float |
|
Recommended |
Dose 4 med 1 |
|
|
|
Query
|
se14sl14 |
Integer |
|
Recommended |
Dose 4 Short acting or long acting med 1 |
1;2
|
1=Short acting; 2=Long acting
|
|
Query
|
se14mg15 |
Float |
|
Recommended |
Dose 5 med 1 |
|
|
|
Query
|
se14sl15 |
Integer |
|
Recommended |
Dose 5 Short acting or long acting med 1 |
1;2
|
1=Short acting; 2=Long acting
|
|
Query
|
medication2_name |
String |
500
|
Recommended |
Name second medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
se14n2 |
Query
|
se14t2 |
Integer |
|
Recommended |
Times taken per day med 2 |
|
|
|
|
medication2_dosage |
String |
100
|
Recommended |
Second medication dosage |
|
0 = No medication; 999 = Missing
|
se14mg21 |
Query
|
se14sl21 |
Integer |
|
Recommended |
Dose 1 Short acting or long acting med 2 |
1;2
|
1=Short acting; 2=Long acting
|
|
Query
|
se14mg22 |
Float |
|
Recommended |
Dose 2 med 2 |
|
|
|
Query
|
se14sl22 |
Integer |
|
Recommended |
Dose 2 Short acting or long acting med 2 |
1;2
|
1=Short acting; 2=Long acting
|
|
Query
|
se14mg23 |
Float |
|
Recommended |
Dose 3 med 2 |
|
|
|
Query
|
se14sl23 |
Integer |
|
Recommended |
Dose 3 Short acting or long acting med 2 |
1;2
|
1=Short acting; 2=Long acting
|
|
Query
|
se14mg24 |
Float |
|
Recommended |
Dose 4 med 2 |
|
|
|
Query
|
se14sl24 |
Integer |
|
Recommended |
Dose 4 Short acting or long acting med 2 |
1;2
|
1=Short acting; 2=Long acting
|
|
Query
|
se14mg25 |
Float |
|
Recommended |
Dose 5 med 2 |
|
|
|
Query
|
se14sl25 |
Integer |
|
Recommended |
Dose 5 Short acting or long acting med 2 |
1;2
|
1=Short acting; 2=Long acting
|
|
Query
|
respond_detail_oth_spec |
String |
255
|
Recommended |
Respondent details |
|
|
informnt, relse |
Query
|
trt_grp |
String |
10
|
Recommended |
Treatment Group Assignment |
1;1AO;1CT;2; 3;4;5;6;7;8;9;10;11;12; O; P; CCA; GCT; TCT; TAU; CGC; ESDM; NA; EG
|
1=Group 1 first 8 weeks; 2=Group 2; 3=Group 3; 4 =active; 5=sham; 6=none; 7=ESDM High intensity; 8=ESDM Low intensity; 9=EIBI High intensity; 10=EIBI Low intensity; ESDM = Early Start Denver Model; EIBI = Early and Intensive Behavioral Intervention; 11 = Navigator; 12 = Care manager; 13=Waitlist Control; 14=Treatment; 1AO=Group 1 8 week add on; 1CT=Group 1 8 week cross taper; O=Oxytocin; P=Placebo; CCA=Community Control Arm; GCT=Generalized Cognitive Training; TCT=Targeted Cognitive Training; TAU=Treatment as Usual; CGC = Computer Games Control; NA=not assigned to treatment group; EG= Experimental Group
|
|
Query
|
etype |
String |
10
|
Recommended |
Rating Period |
BSL;WK1;WK2;WK3;WK4;WK5;WK6;WK7;WK8;WK9;WK10;WK11;WK12;WK13;WK14;WK15;WK16
|
BSL=Baseline; WK1-WK16=Weeks 1-16
|
|
Query
|
relationship |
Integer |
|
Recommended |
Relationship of respondent to individual |
|
1 = Biological mom; 2 = Biological dad; 3 = Grandparent; 4 = Special education (sped) teacher; 5 = General education teacher; 6 = Occupational therapist; 7 = Speech and language therapist; 8 = Behavioral therapist; 9 = Paraprofessional; 10 = Aide; 11 = Principal; 12 = Administrator; 14 = Content teacher; 15 = Parent center director; 16 = Self; 17=Adoptive mother; 18=Adoptive father; 19=Foster mother; 20 = Foster father; 21=Grandmother; 22=Grandfather; 23=Step-mother; 24 = Step-father; 25=Aunt; 26=Uncle; 28=Both parents;31= Grandmother from mother side; 32= Grandfather from mother side; 33= Grandmother from father side; 34= Grandfather from father side; 36= Brother; 37= Sister; 38= Cousin; 39= female caregiver; 40=male caregiver; 41=Female child; 42=Male child; 43=Spouse/Mate; 44=Friend; 45=Parent; 46=Significant other; 47=Sibling; 48=Son/Daughter; 49=Son-in-law/Daughter-in law; 50=Other Relative; 51=Paid caregiver; 52=Friends; 53=Roommate; 54=Supervisor; 55=mother's boyfriend; 56=other parental figure; 57=Summary; 58=counselor ; 59 = other female relative; 60 = other male relative; 61 = non-relative ; 62=Maternal Aunt; 63=Maternal Uncle; 64=Maternal Cousin; 65 = Paternal Aunt; 66=Paternal Uncle; 67=Paternal Cousin ; 68=Biological/Adoptive Mother and Grandmother; 69=Biological/Adoptive Mother and Stepmother and Grandmother; 70=Biological/Adoptive Mother and Grandmother and Foster Father; 71=Biological/Adoptive Mother and Stepmother and Foster Mother; 72=Biological/Adoptive Mother and Foster Mother; 73=Biological/Adoptive Mother and Biological/Adoptive Father; 74=Biological/Adoptive Mother and Stepmother and Biological/Adoptive Father; 75=Biological/Adoptive Mother and Other; 76=Biological/Adoptive Mother and Stepmother and Stepfather; 77=Biological/Adoptive Mother and Stepfather; 78=Biological/Adoptive Mother and Grandfather; 79=Biological/Adoptive Mother and Stepmother and Foster Father; 80=Biological/Adoptive Mother and Stepmother; 81=Guardian, female; 82=Other female; 83=Guardian, male; 84=Other male; 85=Other/Grandparent/Nanny; 86 = Mother, Father, Guardian; 87 = Daughter, son, grandchild; 88 = Professional (e.g., social worker, nurse, therapist, psychiatrist, or group home staff); -999=Missing; 89 = Biological parent; 90=Other; 91 = Stepparent; 92 = Adoptive parent; 93 = Foster parent; 94 = Co-worker
|
infrmnt2 |
Query
|
sefcars1 |
Integer |
|
Recommended |
Cardiovascular - Dizziness (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
dizziness |
Query
|
sefcars2 |
Integer |
|
Recommended |
Cardiovascular - Faintness (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
faintness |
Query
|
sefcars3 |
Integer |
|
Recommended |
Cardiovascular - Palpitations (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefcars4 |
Integer |
|
Recommended |
Cardiovascular - Tachycardia (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
se_q25, sft028, tachycardia |
Query
|
sefcars5 |
Integer |
|
Recommended |
Cardiovascular - Other (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefcarf1 |
Integer |
|
Recommended |
Cardiovascular - Dizziness (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcarf2 |
Integer |
|
Recommended |
Cardiovascular - Faintness (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcarf3 |
Integer |
|
Recommended |
Cardiovascular - Palpitations (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcarf4 |
Integer |
|
Recommended |
Cardiovascular - Tachycardia (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcarf5 |
Integer |
|
Recommended |
Cardiovascular - Other (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgass6 |
Integer |
|
Recommended |
Gastrointestinal - Abdominal pain (Severity) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4= not done
|
safte30, sft032 |
Query
|
sefgass8 |
Integer |
|
Recommended |
Gastrointestinal - Weight loss (Severity) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4= not done
|
safte44, sft047 |
Query
|
sefgass9 |
Integer |
|
Recommended |
Gastrointestinal - Appetite increase (Severity) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4= not done
|
safte42, se_q16, seg_q11, sft045 |
Query
|
sefgass10 |
Integer |
|
Recommended |
Gastrointestinal - Weight gain (Severity) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4= not done
|
safte43, sft046 |
Query
|
sefgass11 |
Integer |
|
Recommended |
Gastrointestinal - Constipation (Severity) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4= not done
|
constipation, safte31, se_q10, seg_q13, sft033 |
Query
|
sefgass13 |
Integer |
|
Recommended |
Gastrointestinal - Heartburn (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefgass14 |
Integer |
|
Recommended |
Gastrointestinal - Jaundice (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefgass15 |
Integer |
|
Recommended |
Gastrointestinal - Nausea (Severity) |
0::3; -9; 9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 9 = Not Rated;
|
aer024a, hbr023a, nausea |
Query
|
sefgass16 |
Integer |
|
Recommended |
Gastrointestinal - Vomiting (Severity) |
0::3; -9; 9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 9 = Not Rated;
|
aer025a, hbr024a, vomiting |
Query
|
sefgass17 |
Integer |
|
Recommended |
Gastrointestinal - Other (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefgasf6 |
Integer |
|
Recommended |
Gastrointestinal - Abdominal pain (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgasf8 |
Integer |
|
Recommended |
Gastrointestinal - Weight loss (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgasf9 |
Integer |
|
Recommended |
Gastrointestinal - Appetite increase (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgasf10 |
Integer |
|
Recommended |
Gastrointestinal - Weight gain (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgasf11 |
Integer |
|
Recommended |
Gastrointestinal - Constipation (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgasf13 |
Integer |
|
Recommended |
Gastrointestinal - Heartburn (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgasf14 |
Integer |
|
Recommended |
Gastrointestinal - Jaundice (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgasf15 |
Integer |
|
Recommended |
Gastrointestinal - Nausea (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgasf16 |
Integer |
|
Recommended |
Gastrointestinal - Vomiting (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgasf17 |
Integer |
|
Recommended |
Gastrointestinal - Other (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnss18 |
Integer |
|
Recommended |
Central Nervous System - Drooling (Severity) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done
|
safte19, se_q15 |
Query
|
sefcnss19 |
Integer |
|
Recommended |
Central Nervous System - Dizziness (Severity) |
0::3; -9; 9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 9 = Not Rated
|
|
Query
|
sefcnss20 |
Integer |
|
Recommended |
Central Nervous System - Headaches (Severity) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done
|
aer013a, safte14 |
Query
|
sefcnss21 |
Integer |
|
Recommended |
Central Nervous System - Convulsions (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
se_q01 |
Query
|
sefcnss22 |
Integer |
|
Recommended |
Central Nervous System - Difficulty falling asleep (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnss23 |
Integer |
|
Recommended |
Central Nervous System - Difficulty arousing in AM (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnss24 |
Integer |
|
Recommended |
Central Nervous System - Difficulty staying asleep (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnss25 |
Integer |
|
Recommended |
Central Nervous System - Drowsiness (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
safte03 |
Query
|
sefcnss26 |
Integer |
|
Recommended |
Central Nervous System - Monotonous speech (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnss27 |
Integer |
|
Recommended |
Central Nervous System - Pallor (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnss28 |
Integer |
|
Recommended |
Central Nervous System - Slurred speech (Severity) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done; -9 =missing
|
safte25, sft027 |
Query
|
sefcnss29 |
Integer |
|
Recommended |
Central Nervous System - Sweating (Severity) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done
|
safte39, sft042 |
Query
|
sefcnss30 |
Integer |
|
Recommended |
Central Nervous System - Tremor (Severity) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done
|
safte23, sft024, tremor |
Query
|
sefcnss31 |
Integer |
|
Recommended |
Central Nervous System - Excitement (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnss32 |
Integer |
|
Recommended |
Central Nervous System - Depression (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnss33 |
Integer |
|
Recommended |
Central Nervous System - Lethargy (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnss34 |
Integer |
|
Recommended |
Central Nervous System - Irritability (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
aer029a, safte06, sft007 |
Query
|
sefcnss35 |
Integer |
|
Recommended |
Central Nervous System - Outbursts of anger (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnss36 |
Integer |
|
Recommended |
Central Nervous System - Difficulty concentrating (Severity) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done
|
aer011a, hbr010a, safte08 |
Query
|
sefcnss37 |
Integer |
|
Recommended |
Central Nervous System - Sadness (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnss38 |
Integer |
|
Recommended |
Central Nervous System - Other (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnss39 |
Integer |
|
Recommended |
Central Nervous System - Motor tics (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnss40 |
Integer |
|
Recommended |
Central Nervous System - Vocal tics (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnss41 |
Integer |
|
Recommended |
Central Nervous System - Other tic (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
sefcnsf18 |
Integer |
|
Recommended |
Central Nervous System - Drooling (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf19 |
Integer |
|
Recommended |
Central Nervous System - Dizziness (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf20 |
Integer |
|
Recommended |
Central Nervous System - Headaches (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf21 |
Integer |
|
Recommended |
Central Nervous System - Convulsions (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf22 |
Integer |
|
Recommended |
Central Nervous System - Difficulty falling asleep (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf23 |
Integer |
|
Recommended |
Central Nervous System - Difficulty arousing in AM (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf24 |
Integer |
|
Recommended |
Central Nervous System - Difficulty staying asleep (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf25 |
Integer |
|
Recommended |
Central Nervous System - Drowsiness (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf26 |
Integer |
|
Recommended |
Central Nervous System - Monotonous speech (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf27 |
Integer |
|
Recommended |
Central Nervous System - Pallor (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf28 |
Integer |
|
Recommended |
Central Nervous System - Slurred speech (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf29 |
Integer |
|
Recommended |
Central Nervous System - Sweating (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf30 |
Integer |
|
Recommended |
Central Nervous System - Tremor (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf31 |
Integer |
|
Recommended |
Central Nervous System - Excitement (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf32 |
Integer |
|
Recommended |
Central Nervous System - Depression (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf33 |
Integer |
|
Recommended |
Central Nervous System - Lethargy (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf34 |
Integer |
|
Recommended |
Central Nervous System - Irritability (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf35 |
Integer |
|
Recommended |
Central Nervous System - Outbursts of anger (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf36 |
Integer |
|
Recommended |
Central Nervous System - Difficulty concentrating (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf37 |
Integer |
|
Recommended |
Central Nervous System - Sadness (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf38 |
Integer |
|
Recommended |
Central Nervous System - Other (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf39 |
Integer |
|
Recommended |
Central Nervous System - Motor tics (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf40 |
Integer |
|
Recommended |
Central Nervous System - Vocal tics (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefcnsf41 |
Integer |
|
Recommended |
Central Nervous System - Other tic (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefocus42 |
Integer |
|
Recommended |
Ocular - Blurring (Severity) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefocus43 |
Integer |
|
Recommended |
Ocular - Other (Severity) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefocuf42 |
Integer |
|
Recommended |
Ocular - Blurring (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefocuf43 |
Integer |
|
Recommended |
Ocular - Other (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
seforals44 |
Integer |
|
Recommended |
Mouth and Nose - Dry mouth (Severity) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4= not done
|
drymouth, safte18, se_q17, seg_q12, sft020 |
Query
|
seforals45 |
Integer |
|
Recommended |
Mouth and Nose - Nasal congestion (Severity) |
0::4; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4= not done
|
congestion, safte17, sft019 |
Query
|
seforals46 |
Integer |
|
Recommended |
Mouth and Nose - Other (Severity) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
seforalf44 |
Integer |
|
Recommended |
Mouth and Nose - Dry mouth (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
seforalf45 |
Integer |
|
Recommended |
Mouth and Nose - Nasal congestion (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
seforalf46 |
Integer |
|
Recommended |
Mouth and Nose - Other (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgens47 |
Integer |
|
Recommended |
Genito Urinary - Delayed urination (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefgens48 |
Integer |
|
Recommended |
Genito Urinary - Frequent urination (Severity) |
0::4
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; 4= not done
|
safte34 |
Query
|
sefgens49 |
Integer |
|
Recommended |
Genito Urinary - Enuresis (Severity) |
0::3; 9; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; 9 = Not Rated; -9 = Unknown
|
se_q19a |
Query
|
sefgens50 |
Integer |
|
Recommended |
Genito Urinary - Other (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefgenf47 |
Integer |
|
Recommended |
Genito Urinary - Delayed urination (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgenf48 |
Integer |
|
Recommended |
Genito Urinary - Frequent urination (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgenf49 |
Integer |
|
Recommended |
Genito Urinary - Enuresis (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgenf50 |
Integer |
|
Recommended |
Genito Urinary - Other (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefders51 |
Integer |
|
Recommended |
Dermatology - Photosensitivity (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefders52 |
Integer |
|
Recommended |
Dermatology - Itching (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefders53 |
Integer |
|
Recommended |
Dermatology - Rash (Severity) |
0::4
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; 4=not done
|
aer026a, safte45 |
Query
|
sefders54 |
Integer |
|
Recommended |
Dermatology - Other (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefderf51 |
Integer |
|
Recommended |
Dermatology - Photosensitivity (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefderf52 |
Integer |
|
Recommended |
Dermatology - Itching (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefderf53 |
Integer |
|
Recommended |
Dermatology - Rash (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefderf54 |
Integer |
|
Recommended |
Dermatology - Other (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefmuss55 |
Integer |
|
Recommended |
Musculo-Skeletal - Joint aches (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefmuss56 |
Integer |
|
Recommended |
Musculo-Skeletal - Muscular cramps (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
safte120, sft022 |
Query
|
sefmuss57 |
Integer |
|
Recommended |
Musculo-Skeletal - Muscle weakness (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
weakness |
Query
|
sefmuss58 |
Integer |
|
Recommended |
Musculo-Skeletal - Other (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefmusf55 |
Integer |
|
Recommended |
Musculo-Skeletal - Joint aches (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefmusf56 |
Integer |
|
Recommended |
Musculo-Skeletal - Muscular cramps (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefmusf57 |
Integer |
|
Recommended |
Musculo-Skeletal - Muscle weakness (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefmusf58 |
Integer |
|
Recommended |
Musculo-Skeletal - Other (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefoths59 |
Integer |
|
Recommended |
Other - Excessive thirst (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefoths60 |
Integer |
|
Recommended |
Other - Pallor (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefoths61 |
Integer |
|
Recommended |
Other - Fever (Severity) |
0::3; 9; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; 9 = Not Rated; -9 = Unknown
|
|
Query
|
sefoths62 |
Integer |
|
Recommended |
Other - Other (Severity) |
0::3
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe
|
|
Query
|
sefothf59 |
Integer |
|
Recommended |
Other - Excessive thirst (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefothf60 |
Integer |
|
Recommended |
Other - Pallor (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefothf61 |
Integer |
|
Recommended |
Other - Fever (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefothf62 |
Integer |
|
Recommended |
Other - Other (Frequency) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgasf7 |
Integer |
|
Recommended |
Appetite decrease (Frequency |
0::3
|
0=Not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
sefgasf12 |
Integer |
|
Recommended |
Diarrhea (Frequency) |
0::3
|
0=Not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
aer003 |
Integer |
|
Recommended |
Recently seen a doctor or medical professional for any reason? |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
hbr003 |
|
aer005a |
String |
30
|
Recommended |
Sleep start time: (hh:mm, 24-hour clock; enter 55:55 if unknown) |
|
|
|
|
aer005b |
String |
30
|
Recommended |
Sleep end time:
(hh:mm, 24-hour clock; enter 55:55 if unknown) |
|
|
|
|
aer006b |
String |
250
|
Recommended |
Drowsiness/Sedation: Comment |
|
|
hbr005b |
Query
|
aer007a |
Integer |
|
Recommended |
Decreased Energy/Fatigue |
0::4;-9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done
|
hbr006a, safte05, sft005 |
|
aer007b |
String |
250
|
Recommended |
Decreased Energy/Fatigue: Comment |
|
|
hbr006b |
Query
|
aer008a |
Integer |
|
Recommended |
Feeling drunk |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr007a |
|
aer008b |
String |
250
|
Recommended |
Feeling drunk: Comment |
|
|
hbr007b |
Query
|
aer009a |
Integer |
|
Recommended |
Dreamy state |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr008a |
|
aer009b |
String |
250
|
Recommended |
Dreamy state: Comment |
|
|
hbr008b |
Query
|
aer010a |
Integer |
|
Recommended |
Feeling remote or "out of it" (derealization) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr009a, sft012 |
|
aer010b |
String |
250
|
Recommended |
Feeling remote or "out of it" (derealization): Comment |
|
|
hbr009b |
|
aer011b |
String |
250
|
Recommended |
Trouble concentrating: Comment |
|
|
hbr010b |
|
aer012b |
String |
250
|
Recommended |
Anxious/Nervous/Fearful: Comment |
|
|
hbr011b |
|
aer013b |
String |
250
|
Recommended |
Headache: Comment |
|
|
hbr012b |
Query
|
aer014a |
Integer |
|
Recommended |
Tingling or numbness (paresthesia) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr013a, safte12 |
|
aer014b |
String |
250
|
Recommended |
Tingling or numbness (paresthesia): Comment |
|
|
hbr013b |
Query
|
aer015a |
Integer |
|
Recommended |
Loss of sensation |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr014a |
|
aer015b |
String |
250
|
Recommended |
Loss of sensation: Comment |
|
|
hbr014b |
Query
|
aer016a |
Integer |
|
Recommended |
Blurred vision |
0::4;-9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done
|
hbr015a, safte15, se_q18, sft017, vision |
|
aer016b |
String |
250
|
Recommended |
Blurred vision: Comment |
|
|
hbr015b |
Query
|
aer017a |
Integer |
|
Recommended |
Double vision |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr016a |
|
aer017b |
String |
250
|
Recommended |
Double vision: Comment |
|
|
hbr016b |
|
aer018b |
String |
250
|
Recommended |
Dizziness, loss of balance: Comment |
|
|
hbr017b |
Query
|
aer019a |
Integer |
|
Recommended |
Loss of Balance |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr018a |
|
aer019b |
String |
250
|
Recommended |
Loss of Balance: Comment |
|
|
hbr018b |
Query
|
aer020a |
Integer |
|
Recommended |
Hot Flashes |
0::4;-9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done
|
hbr019a, safte52 |
|
aer020b |
String |
250
|
Recommended |
Hot Flashes: Comment |
|
|
hbr019b |
Query
|
aer021a |
Integer |
|
Recommended |
Cold sweat |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr020a |
|
aer021b |
String |
250
|
Recommended |
Cold sweat: Comment |
|
|
hbr020b |
Query
|
aer022a |
Integer |
|
Recommended |
Change in bowel function |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr021a |
|
aer022b |
String |
250
|
Recommended |
Change in bowel function: Comment |
|
|
hbr021b |
Query
|
aer023a |
Integer |
|
Recommended |
Change in appetite |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr022a |
|
aer023b |
String |
250
|
Recommended |
Change in appetite: Comment |
|
|
hbr022b |
|
aer024b |
String |
250
|
Recommended |
Nausea: Comment |
|
|
hbr023b |
|
aer025b |
String |
250
|
Recommended |
Vomiting: Comment |
|
|
hbr024b |
|
aer026b |
String |
250
|
Recommended |
Skin Rash: Comment |
|
|
hbr025b |
|
aer027b |
String |
250
|
Recommended |
Insomnia: Comment |
|
|
hbr026b |
Query
|
aer028a |
Integer |
|
Recommended |
Increased Energy |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr027a |
|
aer028b |
String |
250
|
Recommended |
Increased Energy: Comment |
|
|
hbr027b |
|
aer029b |
String |
250
|
Recommended |
Agitation; Irritability: Comment |
|
|
hbr028b |
Query
|
aer030a |
Integer |
|
Recommended |
Confusion |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
confusion, hbr029a |
|
aer030b |
String |
250
|
Recommended |
Confusion: Comment |
|
|
hbr029b |
|
aer031b |
String |
250
|
Recommended |
Sadness; Depression: Comment |
|
|
hbr030b |
Query
|
aer032a |
Integer |
|
Recommended |
Reckless Behavior |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr031a |
|
aer032b |
String |
250
|
Recommended |
Reckless Behavior: Comment |
|
|
hbr031b |
|
aer033b |
String |
250
|
Recommended |
Excessive Talking: Comment |
|
|
hbr032b |
|
aer034b |
String |
250
|
Recommended |
Excessively Happy; Silly: Comment |
|
|
hbr033b |
Query
|
aer035a |
Integer |
|
Recommended |
Disinhibited Behavior |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr034a |
|
aer035b |
String |
250
|
Recommended |
Disinhibited Behavior: Comment |
|
|
hbr034b |
Query
|
aer036a |
Integer |
|
Recommended |
Other (Specify in comments) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr035a |
|
aer036b |
String |
250
|
Recommended |
Other: Comment |
|
|
hbr035b |
Query
|
aer037a |
Integer |
|
Recommended |
Other (Specify in comments) |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr036a |
|
aer037b |
String |
250
|
Recommended |
Other: Comment |
|
|
hbr036b |
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
int1, interval, visit_name |
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
studyday, visitdt |
|
study |
String |
100
|
Recommended |
Study; The code for each individual study |
|
|
studyid |
Query
|
completed |
Integer |
|
Recommended |
Checks if completed |
0::3
|
0=No; 1=Yes; 2=Yes, lost; 3=Unverified
|
formcomp, frmcomp, tstst |
Query
|
subtrial_name |
Integer |
|
Recommended |
Name of subtrial |
1::3
|
1=Crossover; 2=Guanfacine; 3= Open Label MPH
|
|
Query
|
seg_q09 |
Integer |
|
Recommended |
Sleep disturbance |
0::4
|
0=Absent 1=Mild 2=Moderate 3=Severe; 4=not done
|
safte02, sft002 |
|
session_id |
String |
20
|
Recommended |
session ID/screening ID |
|
|
screeningid |
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
form_name |
Query
|
tdi_q4e |
Integer |
|
Recommended |
Trouble sleeping |
0::3
|
0=Absent 1=Mild 2=Moderate 3=Severe
|
safte01 |
Query
|
safte07 |
Integer |
|
Recommended |
Poor memory |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
sft008 |
Query
|
safte09 |
Integer |
|
Recommended |
Feeling strange or unreal |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte11 |
Integer |
|
Recommended |
Abnormal sensations |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte16 |
Integer |
|
Recommended |
Ringing in ears or trouble hearing |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte22 |
Integer |
|
Recommended |
Trouble sitting still |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte24 |
Integer |
|
Recommended |
Poor coordination or unsteadiness |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte26 |
Integer |
|
Recommended |
Heartbeat rapid or pounding |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte27 |
Integer |
|
Recommended |
Trouble catching breath |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte28 |
Integer |
|
Recommended |
Chest pain |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
sft030 |
Query
|
safte33 |
Integer |
|
Recommended |
Difficulty starting urination |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte35 |
Integer |
|
Recommended |
Menstrual irregularities |
0::4; -9; -888
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done; -9=missing; -888 =NA
|
se_q23, sft036 |
Query
|
safte36 |
Integer |
|
Recommended |
Loss of sexual interest |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte37 |
Integer |
|
Recommended |
Problems with sexual arousal |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte38 |
Integer |
|
Recommended |
Delayed or absent orgasm |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte40 |
Integer |
|
Recommended |
Fluid retention or swelling |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
adssq9u |
Integer |
|
Recommended |
Severity of Symptom: Decreased appetite (Non-imputed Version) |
0::3
|
0= Not present; 1= Mild; 2= Moderate; 3= Severe
|
safte41, sft044 |
Query
|
safte46 |
Integer |
|
Recommended |
Diminished mental acuity/sharpness |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte47 |
Integer |
|
Recommended |
Difficulties finding words |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte48 |
Integer |
|
Recommended |
Apathy/Emotional Indifference |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte49 |
Integer |
|
Recommended |
Dizziness when you stand up |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte50 |
Integer |
|
Recommended |
Bruising |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte51 |
Integer |
|
Recommended |
Hair thinning/loss |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte53 |
Integer |
|
Recommended |
Clenching of teeth at night |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte54 |
Integer |
|
Recommended |
Strange taste in mouth |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
safte55 |
Integer |
|
Recommended |
Unable to sit still |
0::4
|
0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done
|
|
Query
|
saftse |
Integer |
|
Recommended |
Overall side-effects interference |
1::4; 999
|
1=Overall side-effects interference: No side effects; 2=Overall side-effects interference: Mildly; 3=Overall side-effects interference: Moderately; 4=Overall side-effects interference: Markedly; 999=Overall side-effects interference: Not Done
|
|
Query
|
pwc007 |
Integer |
|
Recommended |
Since last visit: Insomnia |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=unknown
|
sft001 |
Query
|
sft003 |
Integer |
|
Recommended |
Sedation/drowsiness |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft004 |
Integer |
|
Recommended |
Excitement/nervousness |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
excitement |
Query
|
sft006 |
Integer |
|
Recommended |
Malaise |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft009 |
Integer |
|
Recommended |
Mentation impaired |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft010 |
Integer |
|
Recommended |
Libido increase |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft011 |
Integer |
|
Recommended |
Depersonalization |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft014 |
Integer |
|
Recommended |
Sensory perception abnormality |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft015 |
Integer |
|
Recommended |
Dizziness/faintness |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft018 |
Integer |
|
Recommended |
Tinnitus/difficulty hearing |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
se_q28 |
Query
|
sft021 |
Integer |
|
Recommended |
Salivation increased |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
salivation |
Query
|
sft025 |
Integer |
|
Recommended |
Abnormal muscle tone/movement |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft026 |
Integer |
|
Recommended |
Ataxia/impaired coordination |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft029 |
Integer |
|
Recommended |
Hyperventilation |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft031 |
Integer |
|
Recommended |
Nausea/vomiting |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
se_q13 |
Query
|
sft035 |
Integer |
|
Recommended |
Urination problems |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft037 |
Integer |
|
Recommended |
Libido decrease |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft038 |
Integer |
|
Recommended |
Libido increase |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft039 |
Integer |
|
Recommended |
Erectile dysfunction |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft040 |
Integer |
|
Recommended |
Ejaculatory dysfunction |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft041 |
Integer |
|
Recommended |
Orgasmic dysfunction |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft043 |
Integer |
|
Recommended |
Edema |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
|
Query
|
sft048 |
Integer |
|
Recommended |
Dermatitis/allergy |
0::3; -9
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
|
dermatitis |
Query
|
ci_enrolled |
Integer |
|
Recommended |
Participant enrolled |
0;1
|
0=No; 1=Yes
|
enrolled |
Query
|
sitedatasource_1 |
Integer |
|
Recommended |
Source of Data: Site |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
infosrcr |
Query
|
sitedatasource_phone |
Integer |
|
Recommended |
Source of Data: Telephone |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
infosrct |
Query
|
sitedatasource_physician |
Integer |
|
Recommended |
Source of Data: Physician |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
infosrcp |
Query
|
se_q02 |
Integer |
|
Recommended |
Tired during the day |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe;
|
|
Query
|
se_q03 |
Integer |
|
Recommended |
Increased difficulty waking up |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe;
|
|
Query
|
se_q04 |
Integer |
|
Recommended |
Shakiness in arms, legs or hands: tre |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe;
|
|
Query
|
se_q05 |
Integer |
|
Recommended |
Twisting or repetitive tongue movemen |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe;
|
|
Query
|
se_q06 |
Integer |
|
Recommended |
Muscles appearing stiff or stuck |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe;
|
|
Query
|
se_q07 |
Integer |
|
Recommended |
Eyes appearing stuck in one position |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe;
|
|
Query
|
se_q12 |
Integer |
|
Recommended |
Dyspepsia (acid stomach) |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe;
|
|
Query
|
se_q19b |
Integer |
|
Recommended |
Uninary problems - trouble emptying |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe;
|
|
Query
|
se_q20 |
Integer |
|
Recommended |
Rhinitis (runny nose) |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe;
|
|
Query
|
se_q21 |
Integer |
|
Recommended |
Gynecomastia (abnormally enlarged br |
0::3; -9
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe; -9=missing
|
|
Query
|
se_q22 |
Integer |
|
Recommended |
Galactorrehea |
0::3; -9
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe; -9= missing
|
|
Query
|
se_q24 |
Integer |
|
Recommended |
Coughing |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe;
|
|
Query
|
se_q26 |
Integer |
|
Recommended |
Seizures |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe;
|
|
Query
|
se_q27 |
Integer |
|
Recommended |
Skin rash |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
hbr025a |
|
se_30bed |
String |
5
|
Recommended |
BedTime |
|
|
|
|
se_30wk |
String |
5
|
Recommended |
Wake Up Time |
|
|
|
Query
|
se_q31 |
Integer |
|
Recommended |
Peculiar eating habits? |
1;0; -888
|
1 = Yes;0 = No; -888=NA
|
|
Query
|
se_q32 |
Integer |
|
Recommended |
Change in eating habits? |
1;0; -888
|
1 = Yes;0 = No; -888=NA
|
|
Query
|
hbr00a |
Integer |
|
Recommended |
Primary informant |
1::3;-9
|
1=Mother; 2=Father; 3=Subject;; -9=Unknown
|
|
Query
|
hbr004 |
Integer |
|
Recommended |
Any new medications |
0;1;-9
|
0=No; 1=Yes; -9=Unknown
|
|
Query
|
pulse |
Float |
|
Recommended |
Pulse |
|
|
|
Query
|
blood_ps |
Integer |
|
Recommended |
systolic blood pressure |
|
|
|
Query
|
blood_pd |
Integer |
|
Recommended |
diastolic blood pressure |
|
|
|
Query
|
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.
|
|
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.
|
|
Query
|
perstart |
Integer |
|
Recommended |
number of days since baseline start date |
|
Period Rated
|
|
Query
|
perend |
Integer |
|
Recommended |
number of days since baseline end date |
|
Period Rated
|
|
Query
|
daydose |
Integer |
|
Recommended |
Daily dosage during period rated |
|
Medications: with respect to dosing schedule
|
|
Query
|
signspt |
Integer |
|
Recommended |
Are there clinically significant Complaints or Signs Present? |
0;1
|
Yes=1; No=0
|
|
Query
|
dizzyupf |
Integer |
|
Recommended |
Dizziness when standing up (orthostatic hypotension) - Frequency (days per week) |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
dizzyups |
Integer |
|
Recommended |
Dizziness when standing up (orthostatic hypotension) - Severity |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
tachyf |
Integer |
|
Recommended |
Tachycardia (rapid pulse) - Frequency (days per week) |
0::3
|
0=not present; 1=1-2 days; 2=3-4 days; 3=5-7 days
|
|
Query
|
tachys |
Integer |
|
Recommended |
Tachycardia (rapid pulse) - Severity |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
depressf |
Integer |
|
Recommended |
Depression (reduction of ability to enjoy self or anticipate pleasure) - Frequency |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
depresss |
Integer |
|
Recommended |
Depression (reduction of ability to enjoy self or anticipate pleasure) - Severity |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
lethargf |
Integer |
|
Recommended |
Lethargy, apathy, diminished drive - Frequency |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
lethargs |
Integer |
|
Recommended |
Lethargy, apathy, diminished drive - Severity |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
sadf |
Integer |
|
Recommended |
Sadness (crying, feeling blue, sad) - Frequency |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
sads |
Integer |
|
Recommended |
Suicidal tendencies - lifetime |
1;2;3;4;5;6;7
|
1=Absent; 2=Thoughts of dying, but no suicidal thoughts; 3=Occasional thoughts of suicide, no plans; 4=Often thought about suicide or has thought of a specific method; 5=Had a plan or made a gesture; 6=Made preparation for a potentially serious suicide attempt; 7=Suicide attempt with definite intent to die or be potentially medically harmful
|
|
Query
|
cnsoth |
Integer |
|
Recommended |
Other: Central Nervous System |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
ocuoth |
Integer |
|
Recommended |
Other - Ocular |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
|
oth53 |
String |
150
|
Recommended |
Other Side Effects (Specify) |
|
|
|
Query
|
oth53f |
Integer |
|
Recommended |
Other Side Effects - Frequency |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
oth53s |
Integer |
|
Recommended |
Other Side Effects - Severity |
0::3; 9; -9
|
0 = None; 1=Mild; 2=Moderate; 3=Severe; ; 9 = Not Rated; -9 = Unknown
|
|
|
muscoth |
String |
150
|
Recommended |
Other muscular |
|
|
|
Query
|
muscothf |
Integer |
|
Recommended |
Other muscular - Frequency |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
photof |
Integer |
|
Recommended |
Photosensitiviy - Frequency |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
photos |
Integer |
|
Recommended |
Photosensitiviy - Severity |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
fever |
Integer |
|
Recommended |
6.1. Fever over 101F or infection (e.g. strep throat or urinary tract) requiring antibiotics |
1;2;99;-999
|
1= Yes ; 2= No ; 99= D/K ; -999= Missing
|
|
Query
|
dermoth |
Integer |
|
Recommended |
Other dermatology |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
urinoth |
Integer |
|
Recommended |
Other - urinary |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
noseoth |
Integer |
|
Recommended |
Other - nose |
|
|
|
Query
|
ticoth |
Integer |
|
Recommended |
Other tics: central nervous system |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
headf |
Integer |
|
Recommended |
Headache - Frequency |
1::3
|
1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
rigidity |
Integer |
|
Recommended |
rigidity |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
dystonia |
Integer |
|
Recommended |
Dystonia |
0::5
|
0=None; 1=Focal dystonia (more than one joint); 2=Segmental dystonia (two extremities); 3=Generalized dystonia (>2 extremities); 4=None; 5=Focal dystonia (one joint)
|
|
Query
|
aesa18 |
Integer |
|
Recommended |
Akathisia/activation: Have you had any problems with a sense of inner restlessness, or a feeling that you need tomove? Have you had difficulty sitting or standing still due to this restless feeling? (Severe = individual is unable to maintain any position for more than a few seconds) |
0;1;2;3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe
|
akathisia |
Query
|
syncope |
Integer |
|
Recommended |
syncope |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
bradycardia |
Integer |
|
Recommended |
bradycardia |
0::3
|
0=Absent; 1=Mild; 2=Moderate; 3=Severe
|
|
Query
|
resp_sex |
Integer |
|
Recommended |
gender of respondent |
1;2
|
1=Male; 2=Female
|
|
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
|
|
|
otherspecify |
String |
255
|
Recommended |
Specify other |
|
|
|
|
observation_a_8_9_cmt |
String |
255
|
Recommended |
specify: |
|
|
|
Query
|
sft010a |
Integer |
|
Recommended |
Delusion |
0::3
|
0=Not present; 1=Mild; 2=Moderate; 3=Severe
|
|
|
se_completedbyx |
String |
100
|
Recommended |
If completed by ''Other'', please specify: |
|
|
|
|
se_2 |
Integer |
|
Recommended |
2. Wakes up at night |
0::3
|
0= None; 1= Mild; 2= Moderate; 3= Severe
|
|
|
se_12 |
Integer |
|
Recommended |
12. Forehead pain/discomfort |
0::3
|
0= None; 1= Mild; 2= Moderate; 3= Severe
|
|
|
se_23 |
Integer |
|
Recommended |
23. How much have all these side effects bothered you/your child or interfered with your daily routine? |
0::3
|
0= No side-effects; 1= Mildly; 2= Moderately; 3= Markedly
|
|