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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Side Effects

6,235 Shared Subjects

Side Effects. UCLA Clinician Form
Clinical Assessments
Side Effects
01/07/2014
side_effects01
03/28/2023
View Change History
01
Definition
Submission Template
Query Element Name Data Type Size Required Description Value Range Notes Aliases
subjectkey GUID Required The NDAR Global Unique Identifier (GUID) for research subject NDAR* guid
src_subject_id String 20 Required Subject ID how it's defined in lab/project 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::94;-999
1 = Biological mom; 2 = Biological dad; 3 = Grandparent; 4 = Special education (sped) teacher; 5 = General education teacher; 6 = Occupational therapist; 7 = Speech and language therapist; 8 = Behavioral therapist; 9 = Paraprofessional; 10 = Aide; 11 = Principal; 12 = Administrator; 14 = Content teacher; 15 = Parent center director; 16 = Self; 17=Adoptive mother; 18=Adoptive father; 19=Foster mother; 20 = Foster father; 21=Grandmother; 22=Grandfather; 23=Step-mother; 24 = Step-father; 25=Aunt; 26=Uncle; 28=Both parents;31= Grandmother from mother side; 32= Grandfather from mother side; 33= Grandmother from father side; 34= Grandfather from father side; 36= Brother; 37= Sister; 38= Cousin; 39= female caregiver; 40=male caregiver; 41=Female child; 42=Male child; 43=Spouse/Mate; 44=Friend; 45=Parent; 46=Significant other; 47=Sibling; 48=Son/Daughter; 49=Son-in-law/Daughter-in law; 50=Other Relative; 51=Paid caregiver; 52=Friends; 53=Roommate; 54=Supervisor; 55=mother's boyfriend; 56=other parental figure; 57=Summary; 58=counselor ; 59 = other female relative; 60 = other male relative; 61 = non-relative ; 62=Maternal Aunt; 63=Maternal Uncle; 64=Maternal Cousin; 65 = Paternal Aunt; 66=Paternal Uncle; 67=Paternal Cousin ; 68=Biological/Adoptive Mother and Grandmother; 69=Biological/Adoptive Mother and Stepmother and Grandmother; 70=Biological/Adoptive Mother and Grandmother and Foster Father; 71=Biological/Adoptive Mother and Stepmother and Foster Mother; 72=Biological/Adoptive Mother and Foster Mother; 73=Biological/Adoptive Mother and Biological/Adoptive Father; 74=Biological/Adoptive Mother and Stepmother and Biological/Adoptive Father; 75=Biological/Adoptive Mother and Other; 76=Biological/Adoptive Mother and Stepmother and Stepfather; 77=Biological/Adoptive Mother and Stepfather; 78=Biological/Adoptive Mother and Grandfather; 79=Biological/Adoptive Mother and Stepmother and Foster Father; 80=Biological/Adoptive Mother and Stepmother; 81=Guardian, female; 82=Other female; 83=Guardian, male; 84=Other male; 85=Other/Grandparent/Nanny; 86 = Mother, Father, Guardian; 87 = Daughter, son, grandchild; 88 = Professional (e.g., social worker, nurse, therapist, psychiatrist, or group home staff); -999=Missing; 89 = Biological parent; 90=Other; 91 = Stepparent; 92 = Adoptive parent; 93 = Foster parent; 94 = Co-worker 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
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
  • For valid elements with shared data, on the far left is a Filter button you can use to view a summary of shared data for that element and apply a query filter to your Cart based on selected value ranges

At the top of this page you can also:

  • Use the search bar to filter the elements displayed. This will not filter on the Size of Required columns
  • Download a copy of this definition in CSV format
  • Download a blank CSV submission template prepopulated with the correct structure header rows ready to fill with subject records and upload

Please email the The NDA Help Desk with any questions.

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