|
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 |
|
|
bid, randid, subject_id, subjid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
bars_date, intvdate |
|
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, intvage |
|
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
|
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
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
|
Query
|
cp52 |
Integer |
|
Recommended |
Restless or overactive |
0::3
|
0 = Not true at all 1 = Just a little true 2 = Pretty much true 3 = Very much true
|
bnsa1 |
Query
|
caars50u |
Integer |
|
Recommended |
Question 50. I am restless or overactive |
0::3
|
0 = Not at all/ never; 1 = Just a little/ once in a while; 2 = Pretty much/ often; 3 = Very much/ very frequently
|
bnsa2 |
Query
|
bnsa3 |
Integer |
|
Recommended |
Subjective Distress Related to Restlessness |
0;1;2;3
|
0=No Distress; 1=Mild; 2=Moderate;3=Severe
|
aka3, bars003, bars_subjectdistressrest, bas_3 |
Query
|
bnsa4 |
Integer |
|
Recommended |
Global Clinical Assessment |
0;1;2;3;4;5
|
0=Absent (No evidence of awareness of restlessness. Observation of characteristic movements of akathisia in the absence of a subjective report of inner restlessness or compulsive desire to move the legs should be classified as pseudoakathisia); 1= Questionable (Non-specific inner tension and fidgety movements); 2= Mild Akathisia (Awareness of restlessness in the legs and/or inner restlessness worse when required to stand still. Fidgety movements present, but characteristic restless movements of akathisia not necessarily observed. Condition causes little or no distress); 3= Moderate Akithisia (Awareness of restlessness as described for mild akathisia above, combined with characteristic restless movements such as rocking from foot to foot when standing. Patient finds the condition distressing); 4= Marked Akathisia (Subjective experiences of restlessness includes a compulsive desire to walk or pace. However, the patient is able to remain seated for at least five minutes. The condition is obviously distressing); 5= Severe Akathisia (The patient reports a strong compulsion to pace up and down most of the time. Unable to sit or lie down for more than a few minutes. Constant restlessness which is associated with intense distress and insomnia)
|
aka4, bars004, bars_globalakathisia, bas_4, bnsglob |
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
vers |
Query
|
bnsa1a |
Integer |
|
Recommended |
Objective |
0::3
|
0=Normal, occasional fidgety movements of the limbs; 1=Presence of characteristics restless movements shuffling or tramping movements of the legs/feet, or swinging of one leg, while sitting, and/or rocking from foot to foot or 'walking on the spot' when standing, but movements present for less than half the time; 2=Observed phenomena, as described in (1) above, which are present for at least half the observation period; 3=The patient is constantly engaged in characteristic restless movement, and/or has the inability to remain seated or standing without walking or pacing, during the time observed.
|
aka1, bars001, bas_1, sas_objective |
Query
|
bnsa2a |
Integer |
|
Recommended |
Subjective Awareness of Restlessness |
0::3
|
0=Absence of inner restlessness; 1=Non-specific sense of inner restlessness; 2=The patient is aware of an inability to keep the legs still, or a desire to move the legs, and/or complains of inner restlessness aggravated specifically by being required to stand still; 3=Awareness of an intense compulsion to move most of the time and/or reports a strong desire to walk or pace most of the time
|
aka2, bars002, bars_subjectawarerest, bas_2 |
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
vtypbas |
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
bnsa0b |
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
|
Query
|
intrt |
Integer |
|
Recommended |
Treatment Status Code |
0::2
|
0=Baseline; 1=In Treatment; 2=In Follow-up
|
|
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
|
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 |
|
|
dav1bas |
Query
|
study_id |
Integer |
|
Recommended |
Study ID number |
|
46=Acute Phase; 47=Stabilization Phase
|
|
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
intid |
Query
|
rand_num |
Integer |
|
Recommended |
Randomization Number |
0::2
|
|
|
Query
|
barnes_tot |
Integer |
|
Recommended |
BARNES Total Summary Score |
0::14
|
|
bars_totalscore |
Query
|
assessment_complete |
Integer |
|
Recommended |
Complete? |
0::2
|
0=Incomplete; 1=Unverified; 2=Complete
|
|
|
comments_misc |
String |
4,000
|
Recommended |
Miscellaneous comments on study, interview, methodology relevant to this form data |
|
|
|