|
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 |
|
|
SUBJECT, bid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
|
|
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
|
aescode |
Integer |
|
Recommended |
Staff code number of person completing this form |
|
999= Missing Data
|
OMRACODE |
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
|
Query
|
omrainfo |
Integer |
|
Recommended |
Check if the Patient Takes no other medications |
0;1
|
0=No; 1= Yes
|
|
|
omramedname |
String |
150
|
Recommended |
Name of Medication |
|
|
amra1, omra1 |
Query
|
omramedcode |
Integer |
|
Recommended |
Code for Name of Medication |
|
|
|
|
omramedother |
String |
150
|
Recommended |
Other Medication name (not in list) specified |
|
|
|
Query
|
omraprior |
Integer |
|
Recommended |
Started prior to study entry? (If Yes, go to Primary Indication) |
0;1
|
0=No; 1= Yes
|
amra5, omra2 |
|
omrastart |
Date |
|
Recommended |
Start Date MM/YYYY |
|
|
omra3 |
Query
|
omraprimind |
Integer |
|
Recommended |
Primary Indication 01-14 |
|
|
omra4 |
|
omraprimindo |
String |
150
|
Recommended |
Primary Indication Other specified |
|
|
|
Query
|
omrav1 |
Float |
|
Recommended |
At the study visit V1, indicate the dose of antipsychotics and anticholinergics medication at each visit; -1= patient took other medications at that visit |
|
|
|
Query
|
omrav3 |
Float |
|
Recommended |
At the study visit V2 indicate the dose of antipsychotics and anticholinergics medication at each visit; -1= patient took other medications at that visit |
|
|
|
Query
|
omrav4 |
Float |
|
Recommended |
At the study visit V4 indicate the dose of antipsychotics and anticholinergics medication at each visit; -1= patient took other medications at that visit |
|
|
|
Query
|
amra2 |
Integer |
|
Recommended |
Route (1=PO/2=MI) |
1;2
|
Record all adjunctive medications and oral antipsychotics
|
|
Query
|
amra3a |
Float |
|
Recommended |
Total Dose (include units) |
|
Record all adjunctive medications and oral antipsychotics
|
|
|
amra3b |
String |
20
|
Recommended |
Total Dose (include units) |
|
Record all adjunctive medications and oral antipsychotics
|
|
|
amra4 |
String |
20
|
Recommended |
Frequency (Daily/Weekly/Bi-Weekly/Monthly) |
|
Record all adjunctive medications and oral antipsychotics
|
|
|
medication_start |
Date |
|
Recommended |
Start date of medication |
|
|
|
|
medication_stop |
Date |
|
Recommended |
Stop date of medication |
|
|
|
Query
|
amra7 |
Integer |
|
Recommended |
Primary Indication |
1::15
|
1 = Psychosis; 4 = Agitation/excitement/mania; 2 = Anxiety; 5 = Aggression/violence; 3 = Depression; 6 = Insomnia; 7=Parkinsonism/rigidity/tremors; 8=Substance use disorder; 9=Akathisia; 10=Hyperglycemia/diabetes; 11=Hyperlipidemia; 12=High blood pressure; 13=Constipation; 14=Weight Gain; 15=Other (specify)
|
|
Query
|
amr_m0 |
Integer |
|
Recommended |
V2 (month 0 or baseline) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m0, omra5a |
Query
|
amr_m0_25 |
Integer |
|
Recommended |
V3 (month .25 or week 1) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m0_25, omra5b |
Query
|
amr_m0_5 |
Integer |
|
Recommended |
V4 (month .5 or week 2) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m0_5, omra5c |
Query
|
amr_m0_75 |
Integer |
|
Recommended |
V5 (month .75 or week 3) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m0_75, omra5d |
Query
|
amr_m1 |
Integer |
|
Recommended |
V6 (month 1 or week 4) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m1, omra5e |
Query
|
amr_m1_5 |
Integer |
|
Recommended |
V7 (month 1.5 or week 6) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m1_5, omra5f |
Query
|
amr_m2 |
Integer |
|
Recommended |
V8 (month 2 or week 8) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m2, omra5g |
Query
|
amr_m2_5 |
Integer |
|
Recommended |
V9 (month 2.5 or week 10) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m2_5, omra5h |
Query
|
amr_m3 |
Integer |
|
Recommended |
V10 (month 3 or week 12) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m3, omra5i |
Query
|
amr_m4 |
Integer |
|
Recommended |
V11 (month 4 or week 16) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m4, omra5j |
Query
|
amr_m5 |
Integer |
|
Recommended |
V12 (month 5 or week 20) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m5 |
Query
|
amr_m6 |
Integer |
|
Recommended |
V13 (month 6 or week 24) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m6 |
Query
|
amr_m7 |
Integer |
|
Recommended |
V14 (month 7 or week 28) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m7 |
Query
|
amr_m8 |
Integer |
|
Recommended |
V15 (month 8 or week 32) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m8 |
Query
|
amr_m9 |
Integer |
|
Recommended |
V16 (month 9 or week 36) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m9 |
Query
|
amr_m10 |
Integer |
|
Recommended |
V17 (month 10 or week 40) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m10 |
Query
|
amr_m11 |
Integer |
|
Recommended |
V18 (month 11 or week 44) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m11 |
Query
|
amr_m12 |
Integer |
|
Recommended |
V19 (month 12 or week 48) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m12 |
Query
|
amr_m13 |
Integer |
|
Recommended |
V20 (month 13 or week 52) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m13 |
Query
|
amr_m14 |
Integer |
|
Recommended |
V21 (month 14 or week 56) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m14 |
Query
|
amr_m15 |
Integer |
|
Recommended |
V22 (month 15 or week 60) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m15 |
Query
|
amr_m16 |
Integer |
|
Recommended |
V23 (month 16 or week 64) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m16 |
Query
|
amr_m17 |
Integer |
|
Recommended |
V24 (month 17 or week 68) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m17 |
Query
|
amr_m18 |
Integer |
|
Recommended |
V25 (month 18 or week 92) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m18 |
Query
|
amr_m19 |
Integer |
|
Recommended |
V26 (month 19 or week 96) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m19 |
Query
|
amr_m20 |
Integer |
|
Recommended |
V27 (month 20 or week 100) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m20 |
Query
|
amr_m21 |
Integer |
|
Recommended |
V28 (month 21 or week 104) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m21 |
Query
|
amr_m22 |
Integer |
|
Recommended |
V29 (month 22 or week 108) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m22 |
Query
|
amr_m23 |
Integer |
|
Recommended |
V30 (month 23 or week 112) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m23 |
Query
|
amr_m24 |
Integer |
|
Recommended |
V31 (month 24 or week 116) |
0;1
|
At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).
|
omr_m24 |
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
vers |
Query
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
|
Query
|
omra3a |
Integer |
|
Recommended |
Start date of medication, calculated from randomization date |
-999::999
|
|
|
Query
|
omra3b |
Integer |
|
Recommended |
Stop date of medication, calculated from randomization date |
-999::999
|
|
|
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
|
lineno |
Integer |
|
Recommended |
Line number (lines per participant) |
0::150
|
|
|
Query
|
bpmedcat |
Integer |
|
Recommended |
Addition of or change in blood pressure medication based on OMRA form |
0;1
|
0=No; 1=Yes
|
|
Query
|
ibpmed |
Integer |
|
Recommended |
Indicator for Addition or Change In Blood Pressure Meds |
0;1
|
0=Otherwise; 1=At least one addition of or change in blood pressure medication
|
|
Query
|
llamedc |
Integer |
|
Recommended |
Addition of or change in lipid lowering medication based on LLA form |
0;1
|
0=No; 1=Yes
|
|
Query
|
illamed |
Integer |
|
Recommended |
Indicator for Addition or Change In Lipid Lowering Meds |
0;1
|
0=Otherwise; 1=At least one addition of or change in blood pressure medication
|
|
Query
|
glumedc |
Integer |
|
Recommended |
Addition of or change in glucose medication based on OMRA form |
0;1
|
0=No; 1=Yes
|
|
Query
|
iglumed |
Integer |
|
Recommended |
Indicator for Addition or Change In Glucose Lowering Meds |
0;1
|
0=Otherwise; 1=At least one addition of or change in blood pressure medication
|
|
Query
|
lla_ok |
Integer |
|
Recommended |
No Start/Stop/Change in lipid lowering agent dose (LLA) |
0;1
|
0=No; 1= Yes
|
|
Query
|
lvt_ok |
Integer |
|
Recommended |
No Start/Stop/Change In Lithium/Topiramate/Valproate (LVT) Dose |
0;1
|
0=No; 1= Yes
|
|
Query
|
mmrm |
Integer |
|
Recommended |
Mixed model repeated measures |
0;1
|
0=No; 1= Yes
|
|
Query
|
viol |
String |
30
|
Recommended |
Primary reason for the participant's protocol violation/deviation |
Early discont.; LLA; LVT; Non-Adherent; Rand. Err; Visit window; Sub Lack effic; Sub Side eff; Clin Lack effic; Clin Side eff; Treat site; Unwill proc; Unable cont; Interv ill; Other
|
Early discont.=Early treatment discontinuation; LLA=Start/stop/change LLA; LVT=Start/stop/change LVT ; Non-Adherent=Was not at least 50% adherent with taking study meds over the 5 months of follow-up (V7 ? V11) AND at least 50% adherent with taking study medsover the last month of the study (V11) ; Rand. Err=Randomization error ; Visit window=Outside visit window; Sub Lack effic=Subject's decision: Lack of efficacy of study medication; Sub Side eff=Subject's decision: Side effects of study medication; Clin Lack effic=Clinician's decision: Lack of efficacy of study medication; Clin Side eff=Clinician's decision: Side effects of study medication; Treat site=No longer wants to be treated at study site (or seeking treatment elsewhere); Unwill proc=Unwilling/unable to comply with study procedures; Unable cont=Unable to be contacted/schedule a follow-up; Interv ill=Intervening medical illness that precludes continued participaation in the study
|
|
Query
|
llaviold |
Integer |
|
Recommended |
Date Of Visit for when LLA protocol violation occurred [converted to days from randomization] |
0::365
|
|
|
Query
|
lvtviold |
Integer |
|
Recommended |
Date Of Visit for when LVT protocol violation occurred [converted to days from randomization] |
0::365
|
|
|
|
kitdt |
Date |
|
Recommended |
Date kit assigned |
|
|
|
Query
|
kityn |
Integer |
|
Recommended |
Was a kit number assigned? |
|
0=No; 1=Yes
|
|
|
kitnum1 |
String |
10
|
Recommended |
Medication Kit Number 1 |
|
|
cmd001, kitnum1x |
|
kitnum2 |
String |
10
|
Recommended |
Medication Kit Number 2 |
|
|
cmd002, kitnum2x |
|
comments_misc |
String |
4,000
|
Recommended |
Miscellaneous comments on study, interview, methodology relevant to this form data |
|
|
kitcmnts |