|
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, stepid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
ETFDate |
|
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
|
ETFCODE |
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
|
Query
|
bafinfo |
Integer |
|
Recommended |
Check if the Assessment was not done. |
0::2
|
0=No; 1=Yes; 2=Unverified
|
ETFINFO |
Query
|
etfrsn |
Integer |
|
Recommended |
Reason for End of Treatment Form |
1;2
|
1=Patient completed 40 hours of study treatment; 2=Patient did not complete 40 hours of study treatment, but has reached 12 weeks since randomization
|
|
|
tcdate |
Date |
|
Recommended |
Date of study treatment completion |
|
|
|
Query
|
erlrsn |
String |
1
|
Recommended |
Patient ended study early for which reason |
A;B;C;D; E; F
|
A= Withdrew consent; B=Medical reason; C= Non-compliance with protocol or treatment; D=Terminatin of study by sponsor; E= Subject terminated at discretion of the investigator or sponsor; F= Other
|
|
Query
|
erlrsmds |
String |
255
|
Recommended |
Describe reason for early termination |
|
|
rtd |
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
exitrz |
Query
|
certcode |
Integer |
|
Recommended |
stepbd certification code |
|
|
|
Query
|
exitreas |
Integer |
|
Recommended |
omega3 exit reason |
1::16
|
1=Completion of 52 week protocol; 2=Consent withdrawn; 3=Recurrence of mania; 4=Recurrence of hypomania; 5=Recurrence of depression; 6=Recurrence of mixed episode; 7=Emerging or worsening of subsyndromal mood or neurovegetative symptoms; 8=Intolerable adverse effects; 9=Significant non compliance with protocol; 10=Emergence of significant suicidal ideation; 11=Emergence of significant homicidal ideation; 12=Medical or surgical conditions; 13=Suicide; 14=Homicide; 15=Death (all other causes); 16=Other
|
|
Query
|
unmasked |
Integer |
|
Recommended |
randomization unmasking |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
site_id, siteid |
Query
|
deprexit |
Integer |
|
Recommended |
depression rand care path exit |
0::8
|
0=Treatment responder; 1=Nonresponder 1; 2=Nonresponder 2; 3=Nonresponder 3; 4=Nonresponder 4; 5=Significant non compliance with study protocol; 6=Ineligible; 7=Other; 8=Clinically contra indicated to continue tx
|
|
Query
|
ncmed |
Integer |
|
Recommended |
NC: has GMC contra level 1 or 2 tx |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
nctx |
Integer |
|
Recommended |
noncompliance psych treatment |
0;1;-7
|
0=No; 1=Yes;-7=Refused
|
|
Query
|
nceval |
Integer |
|
Recommended |
noncompliance evaluations |
0;1;-7
|
0=No; 1=Yes;-7=Refused
|
|
Query
|
ncdose |
Integer |
|
Recommended |
noncompliance incorrect dose |
0;1;-7
|
0=No; 1=Yes;-7=Refused
|
|
Query
|
ncoth |
Integer |
|
Recommended |
NC: other reason |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
rtda1 |
Integer |
|
Recommended |
What date was the assigned study treatment stopped? |
0::999
|
|
timest |
Query
|
rtda2 |
Integer |
|
Recommended |
Did patient successfully complete the protocol on the assigned treatment? |
0;1
|
1=Yes; 0=No
|
|
Query
|
rtda3 |
Integer |
|
Recommended |
Was study treatment discontinued for administrative reasons? |
0;1
|
1=Yes; 0=No;Note: This implies that both the patient and the clinical staff judge the assigned antipsychotic treatment to be a success (i.e. adequately effective, with tolerable or no side effects), and that treatment would have continued if not for the administrative reason independent of the study procedures.
|
|
Query
|
rtda4 |
Integer |
|
Recommended |
Was study treatment discontinued based on a clinical decision of inadequate therapeutic effect |
0;1
|
1=Yes; 0=No
|
|
Query
|
rtda5 |
Integer |
|
Recommended |
What was the problematic psychopathology? |
1;2;3
|
1=Postitive Psychopathology; 2=Negative Psychopathology; 3=Affective Psychopathology
|
|
Query
|
rtda6 |
Integer |
|
Recommended |
Was study treatment discontinued based on a clinical decision of unacceptable side effects? |
0;1
|
1=Yes; 0=No
|
|
Query
|
rtda7 |
Integer |
|
Recommended |
Indicate the most problematic side effect |
1;2;3;4;5;6;7;8;9;10;11
|
1=Weight Gain; 2=Lipids; 3=Glucose; 4=EPS; 5=TD; 6=Akathisia/activation; 7=Sexual Dysfunction; 8=Breast changes/galactorrhea; 9=Menstrual irregularities; 10=Hypersensitivity during oral antipsychotic trial; 11=other
|
|
Query
|
rtda8 |
Integer |
|
Recommended |
Was study treatment discontinued based on patient decision, refusal/failure to take the assigned antipsychotic? |
0;1
|
1=Yes; 0=No;Note: This implies that clinical staff believes the patient should continue on the
assigned LAI antipsychotic, but the patient, through words and/or actions, refuses to do so.
|
|
Query
|
rtda9 |
Integer |
|
Recommended |
Indicate patients reason for study medication discontinuation: |
1;2;3;4;5
|
1=Patient lost to follow-up, no information available; 2=Patient believes he/she does not need any antipsychotic
medication; 3=Patient willing to take antipsychotic medication, but not the assigned LAI antipsychotic medication; 4=Patient no longer willing to do study procedures such as blood draws or ratings; 5= Other
|
|
|
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
|
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
|
istatus |
Integer |
|
Recommended |
ISTATUS: 1 =discontinued trt/protocol early, 0 =otherwise (indicator variable for variable STATUS) |
0;1
|
0=Otherwise; 1=Discontinued treatment/protocol early
|
trtdscon |
Query
|
tstdymed |
Integer |
|
Recommended |
Taking Study Meds Up To Time Of Visit |
0;1
|
0=No; 1=Yes
|
|
Query
|
timeall |
Integer |
|
Recommended |
Time To All-Cause Treatment Discontinuation in Days |
0::365
|
|
|
Query
|
discont_status |
String |
2
|
Recommended |
Detailed status of subject in terms of early discontinuation/violation or completing the study |
|
A=Lack of efficacy; B=Unacceptable side effects; C=Participant refusal; D=Lost to Follow-up; E=Disallowed Med; F=Never took study meds; G=Completer
|
|
Query
|
rtdvis |
String |
50
|
Recommended |
Visit on when participant had RTDA form |
|
|
|
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
|
Query
|
compprot |
Integer |
|
Recommended |
Completed treatment protocol |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
er_who_inv |
Integer |
|
Recommended |
investigator initiated termination |
1;0
|
1=yes; 0=no
|
|
Query
|
er_who_sub |
Integer |
|
Recommended |
subject initiated termination |
1;0
|
1=yes; 0=no
|
|
Query
|
er_who_fam |
Integer |
|
Recommended |
family initiated termination |
1;0
|
1=yes; 0=no
|
|
Query
|
pr_protcomp |
Integer |
|
Recommended |
Primary reason for termination: Protocal Complete |
1;0
|
1=yes; 0=no
|
|
Query
|
pr_admin |
Integer |
|
Recommended |
Primary reason for termination: Administrative |
1;0
|
1=yes; 0=no
|
|
Query
|
pr_cinadeff |
Integer |
|
Recommended |
Primary reason for termination: Inadequate Theraeutic effect |
1;0
|
1=yes; 0=no
|
|
Query
|
pr_ciaprob |
String |
3
|
Recommended |
Primary reason for termination: Problematic Psychopathology |
P;N;A;O;N
|
P=positive;N=negative;A=affective;O = other;N = not applicable
|
|
Query
|
pr_ciaprobs |
String |
20
|
Recommended |
Primary reason for termination: Problematic Psychopathology Specify |
|
Actual value
|
|
Query
|
pr_csideeff |
Integer |
|
Recommended |
Primary reason for termination: Unacceptable Side Effects |
1;0
|
1=yes; 0=no
|
|
Query
|
pr_cseepse |
Integer |
|
Recommended |
Primary reason for termination: Unacceptable Side Effect was EPSE |
1;0
|
1=yes; 0=no
|
|
Query
|
pr_csewt |
Integer |
|
Recommended |
Primary reason for termination: Unacceptable Side Effect was Weight |
1;0
|
1=yes; 0=no
|
|
Query
|
pr_csesex |
Integer |
|
Recommended |
Primary reason for termination: Unacceptable Side Effect was Sexual |
1;0
|
1=yes; 0=no
|
|
Query
|
pr_cseinsom |
Integer |
|
Recommended |
Primary reason for termination: Unacceptable Side Effect was Insomnia |
1;0
|
1=yes; 0=no
|
|
Query
|
pr_csemania |
Integer |
|
Recommended |
Primary reason for termination: Unacceptable Side Effect was Mania |
1;0
|
1=yes; 0=no
|
|
Query
|
pr_cseirrit |
Integer |
|
Recommended |
Primary reason for termination: Unacceptable Side Effect was Irritability |
1;0
|
1=yes; 0=no
|
|
Query
|
pr_cseoth |
Integer |
|
Recommended |
Primary reason for termination: Unacceptable Side Effect was Other |
1;0
|
1=yes; 0=no
|
|
Query
|
pr_cseoths |
String |
20
|
Recommended |
Primary reason for termination: Unacceptable Side Effect was Other Specify |
|
Actual value
|
|
Query
|
pr_pnottake |
Integer |
|
Recommended |
Primary reason for termination: Noncompliance |
1;0
|
1=yes; 0=no
|
|
Query
|
er_secreas |
Integer |
|
Recommended |
Other Reasons for Terminating |
1;0
|
1=yes; 0=no
|
|
Query
|
sr_admin |
Integer |
|
Recommended |
Secondary reason for termination: Administrative |
1;0
|
1=yes; 0=no
|
|
Query
|
sr_cinadeff |
Integer |
|
Recommended |
Secondary reason for termination: Inadequate Theraeutic effect |
1;0
|
1=yes; 0=no
|
|
Query
|
sr_ciaprob |
Integer |
|
Recommended |
Secondary reason for termination: Problematic Psychopathology |
1::4
|
1=positive;2=negative;3=affective;4 = other
|
|
Query
|
sr_ciaprobs |
String |
20
|
Recommended |
Secondary reason for termination: Problematic Psychopathology Specify |
|
Actual value
|
|
Query
|
sr_csideeff |
Integer |
|
Recommended |
Secondary reason for termination: Unacceptable Side Effects |
1;0
|
1=yes; 0=no
|
|
Query
|
sr_cseepse |
Integer |
|
Recommended |
Secondary reason for termination: Unacceptable Side Effect was EPSE |
1;0
|
1=yes; 0=no
|
|
Query
|
sr_csewt |
Integer |
|
Recommended |
Secondary reason for termination: Unacceptable Side Effect was Weight |
1;0
|
1=yes; 0=no
|
|
Query
|
sr_csesex |
Integer |
|
Recommended |
Secondary reason for termination: Unacceptable Side Effect was Sexual |
1;0
|
1=yes; 0=no
|
|
Query
|
sr_cseinsom |
Integer |
|
Recommended |
Secondary reason for termination: Unacceptable Side Effect was Insomnia |
1;0
|
1=yes; 0=no
|
|
Query
|
sr_csemania |
Integer |
|
Recommended |
Secondary reason for termination: Unacceptable Side Effect was Mania |
1;0
|
1=yes; 0=no
|
|
Query
|
sr_cseirrit |
Integer |
|
Recommended |
Secondary reason for termination: Unacceptable Side Effect was Irritability |
1;0
|
1=yes; 0=no
|
|
Query
|
sr_cseoth |
Integer |
|
Recommended |
Secondary reason for termination: Unacceptable Side Effect was Other |
1;0
|
1=yes; 0=no
|
|
Query
|
sr_cseoths |
String |
20
|
Recommended |
Secondary reason for termination: Unacceptable Side Effect was Other Specify |
|
|
|
Query
|
sr_pnottake |
Integer |
|
Recommended |
Secondary reason for termination: Noncompliance |
1;0
|
1=yes; 0=no
|
|
Query
|
er_conttreat |
Integer |
|
Recommended |
subject continuing antipsychotic treatment |
0::3
|
0=No; 1=rerandomized; 2=Ziprasidone;3=Community Care
|
|
Query
|
er_guesstrt |
String |
3
|
Recommended |
best guess of treatment received |
Z;C;M;R;O;N;MO; MP
|
Z =Ziprasidone; C =Community Care; M =Molindone; R =Risperidone; O =Olanzapine;N=Not Applicable;MO=Medication Only;MP=Medication+PMT
|
|
Query
|
er_certtrt |
String |
3
|
Recommended |
how certain of best guess |
CS;FS;TG;CU;N
|
CS =Completely Sure; FS =Fairly Sure; TG=Tentative Guess; CU=Completely Uncertain; N= Not Applicable
|
|
Query
|
ptleff |
Integer |
|
Recommended |
Is Lack of Efficacy the type of information on which your guess is based |
0;1
|
0 = Not indicated;1 = Yes
|
|
Query
|
ptpeff |
Integer |
|
Recommended |
Is Presence of efficacy the type of information on which your guess is based |
0;1
|
0 = Not indicated;1 = Yes
|
|
Query
|
ptase |
Integer |
|
Recommended |
Is Absence of side effects the type of information on which your guess is based |
0;1
|
0 = Not indicated;1 = Yes
|
|
Query
|
ptpse |
Integer |
|
Recommended |
Is Presence of side effects the type of information on which your guess is based |
0;1
|
0 = Not indicated;1 = Yes
|
|
Query
|
er_info_na |
Integer |
|
Recommended |
guess basis: Not applicable |
1;0
|
1=yes; 0=no
|
|
Query
|
ptoth |
Integer |
|
Recommended |
Is Other Types of Information the type of information on which your guess is based |
0;1
|
0 = Not indicated;1 = Yes
|
|
Query
|
pt3oth |
String |
60
|
Recommended |
If Other Types of Information the type of information on which your guess is based, explain |
|
|
|
Query
|
sa_any_allwk |
Integer |
|
Recommended |
Suicide attempt reported during any of the study weeks |
0;1; -888; -999
|
0=No; 1=Yes; -888=Not Applicable; -999=Missing;
|
|
Query
|
er_assaults |
Integer |
|
Recommended |
assaults on others during study |
1;0
|
1=yes; 0=no
|
|
Query
|
er_arrests |
Integer |
|
Recommended |
arrests during study |
1;0
|
1=yes; 0=no
|
|
Query
|
er_liveifam |
Integer |
|
Recommended |
current living situation: immediate family |
1;0
|
1=yes; 0=no
|
|
Query
|
er_liveefam |
Integer |
|
Recommended |
current living situation: extended family |
1;0
|
1=yes; 0=no
|
|
Query
|
er_liveghome |
Integer |
|
Recommended |
current living situation: group home |
1;0
|
1=yes; 0=no
|
|
Query
|
er_liveres |
Integer |
|
Recommended |
current living situation: residential |
1;0
|
1=yes; 0=no
|
|
Query
|
er_livephosp |
Integer |
|
Recommended |
current living situation: psychiatric hospital |
1;0
|
1=yes; 0=no
|
|
Query
|
er_livemhoss |
Integer |
|
Recommended |
current living situation: mental hospital study complication |
1;0
|
1=yes; 0=no
|
|
Query
|
er_livemhosu |
Integer |
|
Recommended |
current living situation: mental hospital unrelated problem |
1;0
|
1=yes; 0=no
|
|
Query
|
er_liveshelt |
Integer |
|
Recommended |
current living situation: shelter |
1;0
|
1=yes; 0=no
|
|
Query
|
er_liveoth |
Integer |
|
Recommended |
current living situation: other |
1;0
|
1=yes; 0=no
|
|
Query
|
er_termdx |
String |
6
|
Recommended |
subject's diagnosis at termination |
|
3-5 digit code (XXX.XX)
|
|
Query
|
er_dxchange |
Integer |
|
Recommended |
diagnosis changed from enrollment |
1;0
|
1=yes; 0=no
|
|
Query
|
er_secdx |
Integer |
|
Recommended |
Secondary Diagnosis? (Y or N) |
1;0
|
1=yes; 0=no
|
|
Query
|
encounter1_020 |
String |
100
|
Recommended |
Secondary ICD Diagnosis Code |
|
|
|
Query
|
er_secdx2 |
String |
6
|
Recommended |
Secondary Diagnosis #2 |
|
XXX.XX
|
|
Query
|
er_secdx3 |
String |
6
|
Recommended |
Secondary Diagnosis #3 |
|
XXX.XX
|
|
|
er_secdx4 |
String |
6
|
Recommended |
Secondary Diagnosis #4 |
|
XXX.XX
|
|
|
er_secdx5 |
String |
6
|
Recommended |
Secondary Diagnosis #5 |
|
XXX.XX
|
|
Query
|
treat |
String |
1
|
Recommended |
Treatment for Randomization |
X;Y;Z
|
|
|
Query
|
trm_q3 |
Integer |
|
Recommended |
Date of study termination in days from the randomization/enrollment date (TRM_Q3 = Date of study termination - randomization/enrollment date) |
|
|
|
Query
|
compdt |
Integer |
|
Recommended |
Study completion date, since randomization |
|
Offset from randomization
|
|
Query
|
rand_num |
Integer |
|
Recommended |
Randomization Number |
0::2
|
|
|
|
comments_misc |
String |
4,000
|
Recommended |
Miscellaneous comments on study, interview, methodology relevant to this form data |
|
|
|
Query
|
sigp1 |
Integer |
|
Recommended |
Physician signature present |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
sigd1 |
Integer |
|
Recommended |
Physician/PI signature date (days since randomization) |
|
|
|
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
|
|