|
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 |
|
|
bid, randid, record_id, subjid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
sas_date, sas_doa |
|
interview_age |
Integer |
|
Required |
Age in months at the time of the interview/test/sampling/imaging. |
0 :: 1260
|
Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
|
dema1 |
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
dema2, gender |
Query
|
sas01 |
Integer |
|
Recommended |
Gait |
|
0 = Normal; 1 = Diminution in swing; 2 = Marked diminution; 3 = Stiff gait; 4 = Stooped shuffling gait; 9=not ratable
|
gait, sas1, sas1_gait, sas_1, sas_gait, sasa1 |
Query
|
sas02 |
Integer |
|
Recommended |
Arm Dropping |
|
0 = Normal; 1 = Fall slowed slightly; 2 = Fall slowed; 3 = Marked slowing; 4 = Arms fall as though through resistance; 9=not ratable
|
arm, sas2, sas2_arm_dropping, sas_2, sas_armdrop, sasa2 |
Query
|
sas03 |
Integer |
|
Recommended |
Shoulder Shaking |
|
0 = Normal; 1 = Slight stiffness and resistance; 2 = Moderate stiffness and resistance; 3 = Marked rigidity and difficulty in passive moment; 4 = Extreme stiffness and rigidity with almost a frozen shoulder; 9=not ratable
|
sas3, sas3_shoulder_shaking, sas_3, sas_shouldershake, sasa3, shoulder |
Query
|
sas04 |
Integer |
|
Recommended |
Elbow Rigidity |
|
0 = Normal; 1 = Slight stiffness and resistance; 2 = Moderate stiffness and resistance; 3 = Marked rigidity and difficulty in passive moment; 4 = Extreme stiffness and rigidity with almost a frozen elbow; 9=not ratable
|
elbow, sas4, sas4_elbow_rigidity, sas_4, sas_elbowrigid, sasa4 |
Query
|
sas05 |
Integer |
|
Recommended |
Wrist Rigidity or Fixation of Position |
|
0 = Normal; 1 = Slight stiffness and resistance; 2 = Moderate stiffness and resistance; 3 = Marked rigidity and difficulty in passive moment; 4 = Extreme stiffness and rigidity with almost a frozen wrist; 9=not ratable
|
sas5, sas5_wrist_rigidity, sas_5, sas_wristrigid, sasa5, wrist |
Query
|
sas06 |
Integer |
|
Recommended |
Leg Pendulousness |
|
0 = Legs swing freely; 1= Slight diminution in the swing of legs; 2 = Moderate resistance to swing; 3 = Marked resistance and damping of swing; 4 = Complete absence of swing; 9=not ratable
|
leg, sas6, sas_legpend, sasa6a |
Query
|
sas07 |
Integer |
|
Recommended |
Head Dropping |
|
0 = Head falls completely with a good thump as it hits the table; 1 = Slight slowing in fall; 2 = Moderate slowing in the fall; 3 = Head falls stiffly and slowly; 4 = Head does not reach the examining table; 9=not ratable
|
head, sas_headdrop |
Query
|
sas08 |
Integer |
|
Recommended |
Glabella Tap |
|
0 = 0-5 blinks; 1 = 6-10 blinks; 2 = 11-15 blinks; 3 = 16-20 blinks; 4 = 21 or more blinks; 9=not ratable
|
sas8, sas_7, sas_glabellatap, tap |
Query
|
sas09 |
Integer |
|
Recommended |
Tremor |
|
0 = Normal; 1 = Mild finger tremor, obvious to sight and touch; 2 = Tremor of hand or arm occurring spasmodically; 3 = Persistent tremor of one or more limbs; 4 = Whole body tremor; 9=not ratable
|
sas8_tremor, sas9, sas_8, sas_tremor, sasa6, tremor |
Query
|
sas10 |
Integer |
|
Recommended |
Salivation |
|
0 = Normal; 1 = Excess salivation to the extent that pooling takes place if the mouth is open and tongue is raised; 2 = When excess salivation is present and might occasionally result in difficulty speaking; 3 = Speaking with difficulty because of excess salivation; 4 = Frank drooling; 9=not ratable
|
saliva, sas9_salivation, sas_9, sas_salivation |
Query
|
sas_total |
Float |
|
Recommended |
Simpson-Angus Scale - Total Score |
0 :: 48
|
|
sas_t, sasglob, sastot |
Query
|
visitid |
Integer |
|
Recommended |
MetaTrial Visit ID |
|
System variable: unique code for each type of visit -use to merge files
|
|
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.
|
|
Query
|
visitday |
Integer |
|
Recommended |
day of visit |
|
|
sasa0b, studyday |
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
vers |
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
interval, vtypsas |
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
sasa0ba |
Query
|
sas07b |
Integer |
|
Recommended |
Head Rotation |
|
0=Loose, no resistance; 1=Slight resistance to movement although the time to rotate may be normal; 2=Resistance is apparent and the time of rotation is shortened; 3=Resistance is obvious and rotation is slowed; 4=Head appears stiff and rotation is difficult to carry out; 9=Not ratable
|
sas6_head_rotation, sas_6 |
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
|
|
study |
String |
100
|
Recommended |
Study; The code for each individual study |
|
|
studyid |
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
intid |
Query
|
sas_10 |
Integer |
|
Recommended |
Akathisia |
1::5
|
1=No restlessness reported or observed; 2=Mild restlessness observed, e.g., occasional jiggling of the foot occurs when patient is seated; 3=Moderate restlessness observed, e.g., on several occasions, jiggles foot, crosses and uncrosses legs or twists a part of the body; 4=Restlessness is frequently observed, e.g., the foot or legs moving most of the time; 5=Restlessness persistently observed, e.g., patient cannot sit still, may get up and walk
|
sas10_akathisia |
Query
|
sas_x |
Float |
|
Recommended |
Mean Total Score = Mean of SAS Items 1-10. |
|
|
sas_mean |
Query
|
sas_r25 |
Float |
|
Recommended |
Mean of SAS Items 2-5 |
|
|
|
Query
|
sas_r16 |
Float |
|
Recommended |
Mean of SAS Items 1-6. |
|
|
|
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 |
|
|
dav1sas |
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
|
study_id |
Integer |
|
Recommended |
Study ID number |
|
46=Acute Phase; 47=Stabilization Phase
|
|
Query
|
completed |
Integer |
|
Recommended |
Checks if completed |
0::3
|
0=No; 1=Yes; 2=Yes, lost; 3=Unverified
|
formcomp |
Query
|
confidence_lvl |
Integer |
|
Recommended |
Confidence Level |
1::4
|
1=Very Confident;2=Somewhat confident;3=Some reservations;4=Severe reservations
|
sarconf |
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 |
|
comments |
String |
4,000
|
Recommended |
Comments about assessment |
|
|
sas_notes, sas_notesexpanded |
|
doa_futdt |
String |
20
|
Recommended |
Future date entered (Assessment) |
|
|
sas_doa_futdt |
|
dode |
String |
10
|
Recommended |
Date of Data Entry |
|
|
sas_dode |
|
dode_futdt |
String |
20
|
Recommended |
Future date entered (Data Entry) |
|
|
sas_dode_futdt |
Query
|
form_completed |
Integer |
|
Recommended |
Was the form completed? |
1::4
|
1=Yes; 2=No; 3=Unverified; 4 = N/A-Not in age range
|
sas_form_complete |
Query
|
form_explain |
Integer |
|
Recommended |
Why was this form not completed? |
86::99
|
99=Participant unable to complete due to cognitive impairment; 98=Participant unable to complete due to physical impairment; 97=Participant refused to begin/finish; 96=Participant completed but with less than best effort; 95=Participant unable to be contacted; 94=Participant deceased; 93=Participant withdrew consent; 92=Time constraints; 91=Rater forgot to administer; 90=Missed appointment; 89=Participant was terminated from study; 88=Other;87 = Not Done (reason unspecified); 86 = Not Applicable
|
sas_explain |
|
other_reason_nc |
String |
100
|
Recommended |
Other reason form was not completed |
|
|
sas_other_reason_nc |
Query
|
assessment_complete |
Integer |
|
Recommended |
Complete? |
0::2
|
0=Incomplete; 1=Unverified; 2=Complete
|
sas_complete, sas_simpson_angus_scale_complete |
Query
|
sas7_glabellar_tap |
Integer |
|
Recommended |
Glabellar Tap |
0::4
|
0=No blinks; 1=Questionable; increased blink rate; partial blinks during initial taps that diminish to undetected; 2=Mild, unsuppressible lower lid partial blink; 3=Moderately severe, unsuppressible full blinks; 4=Severe, unsuppressible blepharospasm with every tap
|
|
Query
|
sas11_akinesia |
Integer |
|
Recommended |
Akinesia : Observation of the participant during the entire examination forms the basis for this rating |
0::4
|
0=None; 1=Mild- slowness gives movements a deliberate character, spontaneous speech decreased; 2=Moderate- poverty of movement, few or no gestures, little or no spontaneous speech; 3=Marked- difficulty initiating movement or speech, arrest of ongoing movement; 4=Extreme- moves with great effort or frozen, mute
|
|
|
sas1_gait_com |
String |
200
|
Recommended |
Gait Comments |
|
|
|
|
sas2_arm_dropping_com |
String |
200
|
Recommended |
Arm Dropping Comments |
|
|
|
|
sas3_shoulder_shaking_com |
String |
200
|
Recommended |
Shoulder shaking Comments |
|
|
|
|
sas4_elbow_rigidity_com |
String |
200
|
Recommended |
Elbow rigidity Comments |
|
|
|
|
sas5_wrist_rigidity_com |
String |
200
|
Recommended |
Wrist rigidity Comments |
|
|
|
|
sas8_tremor_com |
String |
200
|
Recommended |
Tremor Comments |
|
|
|
|
sas9_salivation_com |
String |
200
|
Recommended |
Salivation Comments |
|
|
|
|
sas6_head_rotation_com |
String |
200
|
Recommended |
Head Rotation Comments |
|
|
|
|
sas10_akathisia_com |
String |
200
|
Recommended |
Akathisia Comments |
|
|
|
|
sas7_glabellar_tap_com |
String |
200
|
Recommended |
Glabellar Tap Comments |
|
|
|
|
sas11_akinesia_com |
String |
200
|
Recommended |
Akinesia Comments |
|
|
|
Query
|
sas_cogwheel |
Integer |
|
Recommended |
Cogwheeling |
0::4
|
0=normal; 1-slight rigidity; 2=moderate rigidity; 3=marked rigidity; 4=extreme rigidity
|
|
Query
|
sas_dystonic |
Integer |
|
Recommended |
Acute Dystonic Reaction |
0::4
|
0 = None; 1 = one mild, brief episode of dystonia; 2 = one mild to severe episode of dystonia; 3 = two episodes; 4 = more than two episodes
|
|
Query
|
sas_stiffness |
Integer |
|
Recommended |
Subjective Sense of Stiffness |
0::4
|
0 = Normal; 1 = Slight stiffness; 2 = Moderate stiffness; 3 = Marked rigidity with difficulty in passive moment; 4 = Extreme stiffness and rigidity
|
|
Query
|
rand_num |
Integer |
|
Recommended |
Randomization Number |
0::2
|
|
|