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Simpson-Angus Extrapyramidal Side Effects Scale

1,856 Shared Subjects

Simpson-Angus Extrapyramidal Side Effects Scale
Clinical Assessments
Side Effects
02/07/2013
sas01
02/07/2013
View Change History
01
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*
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::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. 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::4; 9
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::4; 9
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::4; 9
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::4; 9
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::4; 9
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::4; 9
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::4; 9
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::4; 9
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::4; 9
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::4; 9
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::4; 9
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
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)
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