|
subjectkey |
GUID |
|
Required |
The NDAR Global Unique Identifier (GUID) for research subject |
NDAR*
|
|
|
|
src_subject_id |
String |
20
|
Required |
Subject ID how it's defined in lab/project |
|
|
CATIEID, bid, case_id, randid, record_id, subjid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
date_of_interview_contact |
|
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.
|
age, bslage, dema1 |
|
sex |
String |
20
|
Required |
Sex of subject at birth |
|
M = Male; F = Female; O=Other; NR = Not reported
|
dema2, gender, sex |
Query
|
food_mouth |
Integer |
|
Recommended |
Food in mouth |
0; 1
|
0 = No; 1 = Yes
|
|
Query
|
rev_teethdentalab |
String |
50
|
Recommended |
Dental abnormalities |
|
NK = Not known
|
|
|
rev_teethdentalabdesc |
String |
255
|
Recommended |
Dental abnormalities: Describe |
|
|
|
Query
|
neuro_involunmove |
String |
50
|
Recommended |
Are there any involuntary movements? |
|
NK = Not known
|
|
|
neuro_involunmovedesc |
String |
255
|
Recommended |
Involuntary Movement - Describe |
|
|
|
Query
|
neuro_bodymove |
String |
50
|
Recommended |
Body Movement |
Normal; Abnormal
|
|
|
|
neuro_bodymovedesc |
String |
255
|
Recommended |
Body Movement - Describe |
|
|
|
Query
|
neuro_handsmove |
String |
50
|
Recommended |
Hand Movement |
Normal; Abnormal
|
|
|
|
neuro_handsmovedesc |
String |
255
|
Recommended |
Hand Movement - Describe |
|
|
|
Query
|
neuro_tonguerest |
String |
50
|
Recommended |
Tongue at Rest |
Normal; Abnormal; NE; _Blank_
|
|
|
|
neuro_tonguerestdesc |
String |
255
|
Recommended |
Tongue at Rest - Describe |
|
|
|
Query
|
neuro_tonguemove |
String |
50
|
Recommended |
Tongue Movement |
Normal; Abnormal; NE; _Blank_
|
|
|
|
neuro_tonguemovedesc |
String |
255
|
Recommended |
Tongue Movement - Describe |
|
|
|
Query
|
neuro_facelegmove |
String |
50
|
Recommended |
Facial and Leg Movement |
Normal; Abnormal; NE; _Blank_
|
|
|
|
neuro_facelegmovedesc |
String |
255
|
Recommended |
Facial and Leg Movement - Describe |
|
|
|
Query
|
neuro_bodyprof |
String |
50
|
Recommended |
Body Profile |
Normal; Abnormal; NE; _Blank_
|
|
|
|
neuro_bodyprofdesc |
String |
255
|
Recommended |
Body Profile - Describe |
|
|
|
Query
|
neuro_trunk |
String |
50
|
Recommended |
Trunk, Legs, and Mouth |
Normal; Abnormal; NE; _Blank_
|
|
|
|
neuro_trunkdesc |
String |
255
|
Recommended |
Trunk, Legs, and Mouth - Describe |
|
|
|
Query
|
neuro_gait |
String |
50
|
Recommended |
Gait |
Normal;Abnormal;NE;_BLANK_
|
NE = Not examined
|
|
|
neuro_gaitdescribe |
String |
255
|
Recommended |
Gait - Describe |
|
|
|
Query
|
aims_facial1_date1 |
Integer |
|
Recommended |
Facial & Oral - Muscles of Facial Expression - Date 1 |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
AIMS01, aims1, aims_1, aimsfac1, amsa1, q01 |
Query
|
aims_facial2_date1 |
Integer |
|
Recommended |
Facial & Oral - Lips and Perioral Area - Date 1 |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
AIMS02, aims2, aims_2, aimsfac2, amsa2, q02 |
Query
|
aims_facial3_date1 |
Integer |
|
Recommended |
Facial & Oral - Jaw - Date 1 |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
AIMS03, aims3, aims_3, aimsfac3, amsa3, q03 |
Query
|
aims_facial4_date1 |
Integer |
|
Recommended |
Facial & Oral - Tongue - Date 1 |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
AIMS04, aims4, aims_4, aimsfac4, amsa4, q04 |
Query
|
aims_facial_score_date1 |
Integer |
|
Recommended |
Facial & Oral Movements - Raw Score - Date 1 |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
amsa5 |
Query
|
aims_extrem5_date1 |
Integer |
|
Recommended |
Extremity - Upper - Date 1 |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
AIMS05, aims5, aims_5, aimsem5, amsa6, q05 |
Query
|
aims_extrem6_date1 |
Integer |
|
Recommended |
Extremity - Lower - Date 1 |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
AIMS06, aims6, aims_6, aimsem6, q06 |
Query
|
aims_extrem_score_date1 |
Integer |
|
Recommended |
Extremity Movements - Raw Score - Date 1 |
0 :: 8
|
|
|
Query
|
aims_trunk_score_date1 |
Integer |
|
Recommended |
Trunk Movements - Raw Score - Date 1 |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
aims7, aims_7, amsa07 |
Query
|
aims_observ_move_ts |
Float |
|
Recommended |
Observed Movements Total Score |
|
|
aims_t |
Query
|
aims_global8_date1 |
Integer |
|
Recommended |
Global Judgement - Severity of abnormal movements overall - Date 1 |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
SEVIND, aims8, aims_8, aimsgj8, amsa8, q08 |
Query
|
aims_global9_date1 |
Integer |
|
Recommended |
Global Judgement - Incapacitation due to abnormal movements - Date 1 |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
AIMS09, aims9, aims_9, aimsgj9, amsa9, q09 |
Query
|
aims_global10_date1 |
Integer |
|
Recommended |
Global Judgement - Patient's awareness of abnormal movements - Date 1 |
0 :: 4; 9; -888
|
0 = No awareness; 1 = Aware, no distress; 2 = Aware, mild distress; 3 = Aware, moderate distress; 4 = Aware, severe distress; 9=missing; -888=NA
|
AIMS10, aims_10, aimsgj10, amsa10, q10 |
Query
|
aims_dental11_date1 |
Integer |
|
Recommended |
Dental Status - Current problems with teeth and/or dentures - Date 1 |
0; 1
|
0 = No; 1 = Yes
|
AIMS11, aims11a, aims_11, aimsgj11, amsa11, q11 |
Query
|
aims_dental12_date1 |
Integer |
|
Recommended |
Dental Status - Dentures worn - Date 1 |
0; 1
|
0 = No; 1 = Yes
|
AIMS12, aims11b, aims_12, aimsgj12, amsa12, q12 |
Query
|
aims_dental13_date1 |
Integer |
|
Recommended |
Dental Status - Edentia - Date 1 |
0; 1
|
0 = No; 1 = Yes
|
aims_13 |
Query
|
aims_14_date1 |
Integer |
|
Recommended |
Movements disappear with sleep - Date 1 |
0; 1
|
0 = No; 1 = Yes
|
aims_14 |
Query
|
phase_ct |
String |
20
|
Recommended |
Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. |
Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1
|
|
phase |
Query
|
visitid |
Integer |
|
Recommended |
MetaTrial Visit ID |
|
System variable: unique code for each type of visit -use to merge files
|
|
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
interval, vtypaims |
Query
|
truncvis |
Integer |
|
Recommended |
Truncated Visit Number |
|
Created variable: provides a numeric visit number for all visits, including unscheduled and end of phase
|
|
Query
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
bsldays |
Query
|
aims07 |
Integer |
|
Recommended |
7. Neck, shoulders, hips |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
aimstm7, amsa7, q07 |
Query
|
bar01 |
Integer |
|
Recommended |
1. Objective |
0::3
|
|
|
Query
|
bar02 |
Integer |
|
Recommended |
2. Subjective awareness of restlessness |
0::3
|
|
|
Query
|
bar03 |
Integer |
|
Recommended |
3. Subjective Distress related to restle |
0::3
|
0 = No distress; 1 = Mild; 2 = Moderate; 3 = Severe
|
|
Query
|
brsgca |
Integer |
|
Recommended |
4. Global clinical assessment of akathis |
0::5
|
0 = Absent; 1 = Questionable; 2 = Mild Akathisia; 3 = Moderate Akathisia; 4 = Marked Akathisia; 5 = Severe Akathisia
|
|
Query
|
sa01 |
Integer |
|
Recommended |
1. Gait |
0::4
|
|
|
Query
|
sa02 |
Integer |
|
Recommended |
2. Arm dropping |
0::4
|
|
|
Query
|
sa03 |
Integer |
|
Recommended |
3. Shoulder shaking |
0::4
|
|
|
Query
|
sa04 |
Integer |
|
Recommended |
4. Elbow rigidity |
0::4
|
|
|
Query
|
sa05 |
Integer |
|
Recommended |
5. Fixation of position or wrist rigidit |
0::4
|
|
|
Query
|
sa06 |
Integer |
|
Recommended |
6. Tremor |
0::4
|
|
|
Query
|
criteria |
Integer |
|
Recommended |
Flag Patients meeting AIMS criteria |
0;1
|
1=Yes, 0=No for patients who meet the Schooler-Kane criteria for Tardive Dyskinesia
|
|
Query
|
facial |
Integer |
|
Recommended |
Movement Severity Score-facial and oral |
|
Created variable with 20% missing data rule applied: Sum of AIMS01-AIMS04
|
|
Query
|
extremty |
Integer |
|
Recommended |
Movement Severity Score-extremity movements |
|
Created variable with 20% missing data rule applied: Sum of AIMS05-AIMS06
|
|
Query
|
base1 |
Integer |
|
Recommended |
Flag Baseline Phase 1/1A Visit |
|
1=Yes for all records meeting this criteria
|
|
Query
|
base1b |
Integer |
|
Recommended |
Flag Baseline Phase 1B Visit |
|
1=Yes for all records meeting this criteria
|
|
Query
|
base2 |
Integer |
|
Recommended |
Flag Baseline Phase 2 Visit |
|
1=Yes for all records meeting this criteria
|
|
Query
|
base3 |
Integer |
|
Recommended |
Flag Baseline Phase 3 Visit |
|
1=Yes for all records meeting this criteria
|
|
Query
|
last1 |
Integer |
|
Recommended |
Flag Last Phase 1/1A Visit |
|
1=Yes for all records meeting this criteria
|
|
Query
|
last1b |
Integer |
|
Recommended |
Flag Last Phase 1B Visit |
|
1=Yes for all records meeting this criteria
|
|
Query
|
last2 |
Integer |
|
Recommended |
Flag Last Phase 2 Visit |
|
1=Yes for all records meeting this criteria
|
|
Query
|
last3 |
Integer |
|
Recommended |
Flag Last Phase 3 Visit |
|
1=Yes for all records meeting this criteria
|
|
Query
|
sevscore |
Integer |
|
Recommended |
Total Movement Severity score |
|
Created variable with 20% missing data rule applied: AIMS Sum of AIMS01-AIMS07
|
|
Query
|
brsobj |
Integer |
|
Recommended |
BRS Obj/Subject Items Score |
|
Created variable with 20% missing data rule applied: Barnes Akathisia Scale Sum of BAR01-BAR03
|
|
Query
|
epsmean |
Float |
|
Recommended |
EPS Scale Mean Score |
|
Created variable with 20% missing data rule applied: Simpson-Angus EPS Scale Mean of SA01-SA06
|
|
Query
|
b1_score |
Integer |
|
Recommended |
Movement Severity Score Phase 1/1A BL |
|
Baseline score for the phase
|
|
Query
|
b1_index |
Integer |
|
Recommended |
Severity Index Phase 1/1A BL |
|
Baseline score for the phase
|
|
Query
|
b1_obj |
Integer |
|
Recommended |
BRS Obj/Subject Phase 1/1A BL |
|
Baseline score for the phase
|
|
Query
|
b1_gca |
Integer |
|
Recommended |
BRS Global Assessment Phase 1/1A BL |
|
Baseline score for the phase
|
|
Query
|
b1_eps |
Float |
|
Recommended |
EPS Scale Mean Phase 1/1A BL |
|
Baseline score for the phase
|
|
Query
|
b1b_scor |
Integer |
|
Recommended |
Movement Severity Score Phase 1B BL |
|
Baseline score for the phase
|
|
Query
|
b1b_indx |
Integer |
|
Recommended |
Severity Index Phase 1B BL |
|
Baseline score for the phase
|
|
Query
|
b1b_obj |
Integer |
|
Recommended |
BRS Obj/Subject Phase 1B BL |
|
Baseline score for the phase
|
|
Query
|
b1b_gca |
Integer |
|
Recommended |
BRS Global Assessment Phase 1B BL |
|
Baseline score for the phase
|
|
Query
|
b1b_eps |
Float |
|
Recommended |
EPS Scale Mean Phase 1B BL |
|
Baseline score for the phase
|
|
Query
|
b2_score |
Integer |
|
Recommended |
Movement Severity Score Phase 2 BL |
|
Baseline score for the phase
|
|
Query
|
b2_index |
Integer |
|
Recommended |
Severity Index Phase 2 BL |
|
Baseline score for the phase
|
|
Query
|
b2_obj |
Integer |
|
Recommended |
BRS Obj/Subject Phase 2 BL |
|
Baseline score for the phase
|
|
Query
|
b2_gca |
Integer |
|
Recommended |
BRS Global Assessment Phase 2 BL |
|
Baseline score for the phase
|
|
Query
|
b2_eps |
Float |
|
Recommended |
EPS Scale Mean Phase 2 BL |
|
Baseline score for the phase
|
|
Query
|
b3_score |
Integer |
|
Recommended |
Movement Severity Score Phase 3 BL |
|
Baseline score for the phase
|
|
Query
|
b3_index |
Integer |
|
Recommended |
Severity Index Phase 3 BL |
|
Baseline score for the phase
|
|
Query
|
b3_obj |
Integer |
|
Recommended |
BRS Obj/Subject Phase 3 BL |
|
Baseline score for the phase
|
|
Query
|
b3_gca |
Integer |
|
Recommended |
BRS Global Assessment Phase 3 BL |
|
Baseline score for the phase
|
|
Query
|
b3_eps |
Float |
|
Recommended |
EPS Scale Mean Phase 3 BL |
|
Baseline score for the phase
|
|
Query
|
c_score |
Integer |
|
Recommended |
Change in Movement Severity Score |
|
Phase-specific change (within each phase, change is calculated from that phase's baseline measurement)
|
|
Query
|
c_index |
Integer |
|
Recommended |
Change in Severity Index |
|
Phase-specific change (within each phase, change is calculated from that phase's baseline measurement)
|
|
Query
|
c_obj |
Integer |
|
Recommended |
Change in BRS Obj/Subject |
|
Phase-specific change (within each phase, change is calculated from that phase's baseline measurement)
|
|
Query
|
c_gca |
Integer |
|
Recommended |
Change in BRS Global Assessment |
|
Phase-specific change (within each phase, change is calculated from that phase's baseline measurement)
|
|
Query
|
c_eps |
Float |
|
Recommended |
Change in EPS Scale Mean |
|
Phase-specific change (within each phase, change is calculated from that phase's baseline measurement)
|
|
Query
|
si2_tep1 |
Integer |
|
Recommended |
Severity Index: TE Value >= 2 in P1 |
0;1
|
1=Yes, 0=No for patients with a treatment-emergent severity index value of >= 2 in phase 1
|
|
Query
|
si1_tep1 |
Integer |
|
Recommended |
Severity Index: TE Value >= 1 in P1 |
0;1
|
1=Yes, 0=No for patients with a treatment-emergent severity index value of >= 2 in phase 1
|
|
Query
|
gca_tep1 |
Integer |
|
Recommended |
Global Clin Assess: TE Value >= 3 in P1 |
0;1
|
1=Yes, 0=No for patients with a treatment-emergent severity index value of >= 2 in phase 1
|
|
Query
|
eps_tep1 |
Integer |
|
Recommended |
EPS Scale Mean: TE Value >= 1 in P1 |
0;1
|
1=Yes, 0=No for patients with a treatment-emergent severity index value of >= 2 in phase 1
|
|
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
site_no |
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
|
|
|
respond_detail_oth_spec |
String |
255
|
Recommended |
Respondent details |
|
|
informnt |
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
|
aimsmed_ttl |
Integer |
|
Recommended |
Total Score (sum of 1-10) |
|
|
aimstot |
Query
|
aimston1 |
Integer |
|
Recommended |
Tongue Movement |
1;2
|
1=No; 2=Yes
|
|
Query
|
aimston2 |
Integer |
|
Recommended |
Tongue Movement-Gross Undulations |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
|
Query
|
aimston3 |
Integer |
|
Recommended |
Tongue Movement-Worm like undulations |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
|
Query
|
aimston4 |
Integer |
|
Recommended |
Tongue Movement-Change from baseline |
1;2
|
1=No; 2=Yes
|
|
Query
|
aimsgait1 |
Integer |
|
Recommended |
Gait-Shuffling |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
|
Query
|
aimsgait2 |
Integer |
|
Recommended |
Gait-Head leaning first |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
|
Query
|
aimsgait3 |
Integer |
|
Recommended |
Gait-Loss of arm swing |
1;2
|
1=No; 2=Yes
|
|
Query
|
aimstrem1 |
Integer |
|
Recommended |
Pill rolling tremor |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
|
Query
|
aimscw1 |
Integer |
|
Recommended |
Cog-wheeling wrist right |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
|
Query
|
aimscw2 |
Integer |
|
Recommended |
Cog-wheeling wrist left |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
|
Query
|
aimscw3 |
Integer |
|
Recommended |
Cog-wheeling elbow right |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
|
Query
|
aimscw4 |
Integer |
|
Recommended |
Cog-wheelling elbow left |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
|
Query
|
aimsmf |
Integer |
|
Recommended |
Masked faces |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
|
Query
|
aimsedd |
Integer |
|
Recommended |
Excessive drooling-daytime |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
|
Query
|
aimsedn |
Integer |
|
Recommended |
Excessive drooling-nighttime |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
|
Query
|
aimsaka |
Integer |
|
Recommended |
Akathesia |
0 :: 4
|
0 = None; 1 = Minimal; 2 = Mild; 3 = Moderate ; 4 = Severe
|
|
Query
|
fseqno |
Integer |
|
Recommended |
Sequence Number |
0::999
|
The FSEQNO variable in the ADJ form has a special interpretation compared to other forms.
For example, ADJ FSEQNO of '1' can be thought of as being '001', FSEQNO of '2' can be thought of as
being '002', and FSEQNO of '3' can be thought of as being '003'.
The first digit of FSEQNO relates to the corresponding ENF sequence number at that visit and the third
digit relates to the specific adjudicator who completed the adjudication form.
|
|
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
vers |
Query
|
amsglob |
Integer |
|
Recommended |
AIMS Global Severity Score (Value of AMSA8: Severity of Abnormal movements) |
0::3
|
0=None, Normal; 1=Minimal (may be extreme normal); 2=Mild; 3=Moderate
|
|
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
amsa0b |
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
|
|
Query
|
lastoc |
Integer |
|
Recommended |
Flag Last Open Choice Phase Visit |
1
|
1=Yes for all records meeting this criteria
|
|
Query
|
baseoc |
Integer |
|
Recommended |
Flag Baseline Open
Choice Phase Visit |
1
|
1=Yes for all records meeting this criteria
|
|
Query
|
boc_scor |
Integer |
|
Recommended |
Movement Severity Score OC Phase BL |
|
Baseline score for the phase
|
|
Query
|
boc_indx |
Integer |
|
Recommended |
Severity Index OC Phase BL |
|
Baseline score for the phase
|
|
Query
|
boc_obj |
Integer |
|
Recommended |
BRS Obj/Subject OC Phase BL |
0::6
|
Baseline score for the phase
|
|
Query
|
boc_gca |
Integer |
|
Recommended |
BRS Global Assessment OC Phase BL |
0::4
|
Baseline score for the phase
|
|
Query
|
boc_eps |
Float |
|
Recommended |
EPS Scale Mean OC Phase BL |
|
Baseline score for the phase
|
|
Query
|
cb_score |
Integer |
|
Recommended |
Study-specific Change in Movement Severity |
|
Change from Phase 1 baseline to score(s) collected in Phase 2
|
|
Query
|
intrt |
Integer |
|
Recommended |
Treatment Status Code |
0::2
|
0=Baseline; 1=In Treatment; 2=In Follow-up
|
|
Query
|
trtgrp_p |
Integer |
|
Recommended |
Treatment Group |
1;2
|
1=Long-Acting Injectable Risperidone Microspheres; 2=Second Generation Oral Antipsychotic Medication
|
|
Query
|
days_visit1 |
Integer |
|
Recommended |
Days from Visit 1 |
|
|
dav1aims |
Query
|
aims_x |
Float |
|
Recommended |
AIMS Mean Total Score = Mean of AIMS seven body areas |
|
|
|
Query
|
aims_td1 |
Integer |
|
Recommended |
AIMS TD Positive 1 = At least one of AIMS seven body areas |
1;2
|
1=No; 2=Yes
|
|
Query
|
aims_td2 |
Integer |
|
Recommended |
AIMS TD Positive 2 = At least two of AIMS seven body areas equal mild or worse OR at least one of AIMS seven body areas equal moderate or worse. |
1;2
|
1=No; 2=Yes
|
|
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
intid |
Query
|
study_id |
Integer |
|
Recommended |
Study ID number |
|
46=Acute Phase; 47=Stabilization Phase
|
|
Query
|
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
|
aims_complete, frmcomp |
Query
|
ci_enrolled |
Integer |
|
Recommended |
Participant enrolled |
0;1
|
0=No; 1=Yes
|
enrolled |
Query
|
confidence_lvl |
Integer |
|
Recommended |
Confidence Level |
1::4
|
1=Very Confident;2=Somewhat confident;3=Some reservations;4=Severe reservations
|
aimconf |
Query
|
sitedatasource_1 |
Integer |
|
Recommended |
Source of Data: Site |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
|
Query
|
sitedatasource_phone |
Integer |
|
Recommended |
Source of Data: Telephone |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
|
Query
|
sitedatasource_physician |
Integer |
|
Recommended |
Source of Data: Physician |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
|
Query
|
eps1 |
Integer |
|
Recommended |
Gait |
1::5; 9
|
1=Normal; 2=Dimunition in swing while walking; 3=Marked dimunition in swing, obvious rigidity in arm; 4=Stiff gait, arms held rigidly before abdomen; 5=Shuffling gait with propulsion and retropulsion; 9=Not ratable
|
|
Query
|
eps2 |
Integer |
|
Recommended |
Arm Dropping |
1::5; 9
|
1=Normal, free fall, loud slap, rebound; 2=Fall slowed slightly, less audible contact, little rebound; 3=Fall slowed, no rebound; 4=Marked slowing, no slap; 5=Arms fall as though facing resistance; 9=Not ratable
|
|
Query
|
eps3 |
Integer |
|
Recommended |
Tremor |
1::5; 9
|
1=Normal; 2=Mild finger tremor; 3=Spasmodic tremor of hand or arm; 4=Persistent tremor of limb(s); 5=Whole body tremor; 9=Not ratable
|
|
Query
|
eps4 |
Integer |
|
Recommended |
Akinesia |
1::5; 9
|
1=No decrease in movement observed; 2=Mild slowness in movements, spontaneous speech decreased; 3=Moderate poverty of movement, little/no gestures or spontaneous speech; 4=Marked difficulty initiating movement or speech; 5=Extreme, moves with great effort or frozen, mute; 9=Not ratable
|
|
Query
|
eps5 |
Integer |
|
Recommended |
Akathisia |
1::5; 9
|
1=No restlessness reported or observed; 2=Mild restlessness observed; 3=Moderate restlessness observed; 4=Restlessness frequently observed; 5=Restlessness persistently observed; 9=Not ratable
|
|
Query
|
epsglob |
Float |
|
Recommended |
Four (4) Item Total Score |
|
|
|
Query
|
monthsbl |
Float |
|
Recommended |
Actual number of months from Baseline |
|
|
|
Query
|
rand_num |
Integer |
|
Recommended |
Randomization Number |
0::2
|
|
|