|
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 |
|
|
CATIEID |
|
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.
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|
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
Query
|
visitid |
Integer |
|
Recommended |
MetaTrial Visit ID |
|
System variable: unique code for each type of visit -use to merge files
|
|
Query
|
copyid |
Integer |
|
Recommended |
Copy ID for multi-copy forms |
|
The case report form used to create this file is a multi- copy form, meaning more than one copy of it can be completed at any one visit. For example, a patient with three adverse events to report at a single visit would have 3 copies of the form at that visit, one for each adverse event. The data file will have three unique records for this patient at this visit. COPYID identifies the order in which the forms were completed at a visit.
|
|
|
prf_term |
String |
100
|
Recommended |
Preferred Term |
|
Coded variable: MedDRA dictionary, version 4.0: Preferred Term This file contains the MedDRA coded terms for any AEs/side effects that were reported spontaneously by the patient at a visit
|
|
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
|
Query
|
truncvis |
Integer |
|
Recommended |
Truncated Visit Number |
|
Created variable: provides a numeric visit number for all visits, including unscheduled and end of phase
|
|
Query
|
phase_ct |
String |
20
|
Recommended |
Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. |
Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1
|
|
|
Query
|
ae |
String |
4,000
|
Recommended |
Adverse event Description |
|
|
|
Query
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
|
|
protocol |
String |
50
|
Recommended |
Protocol [Study] name |
|
|
|
Query
|
anygenae |
Integer |
|
Recommended |
Any general adverse events (AE) |
0;1
|
0=No; 1=Yes
|
|
Query
|
reportid |
Integer |
|
Recommended |
Number of AE Report by Patient |
|
The case report form used to create this file is a ¿multi- copy¿ form, meaning more than one copy of it can be completed at any one visit. For example, a patient with three adverse events to report at a single visit would have 3 copies of the form at that visit, one for each adverse event. The data file will have three unique records for this patient at this visit. COPYID identifies the order in which the forms were completed at a visit.
|
|
Query
|
soc |
String |
100
|
Recommended |
SOC System Organ Class |
|
Coded variable: MedDRA dictionary, version 4.0: System Organ Class This file contains the MedDRA coded terms for any AEs/side effects that were reported spontaneously by the patient at a visit
|
|
Query
|
mdsev |
Integer |
|
Recommended |
Physicians assessment of the severity of the AE |
0::4
|
0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4= NA- Male or postmenopausal female
|
|
Query
|
ptsev |
Integer |
|
Recommended |
Patients assessment of the severity of the AE |
0::4
|
0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4= NA- Male or postmenopausal female
|
|
Query
|
adh_imp |
Integer |
|
Recommended |
Impact of AE on patients adherence to study medication dose regimen |
0::3
|
0 = Unrelated to antipsychotic medication; 1 = Pt thinks SE caused by med - no impact; 2 = Pt thinks SE caused by med and SE affe; 3 = Pt thinks SE caused by med and is not
|
|
Query
|
ptae |
Integer |
|
Recommended |
Patient Reported AE |
0;1
|
0=No; 1=Yes
|
|
Query
|
mdsev_c |
Integer |
|
Recommended |
MD Severity - Created |
0::3
|
0= Absent; 1= Mild; 2= Moderate; 3= Severe
|
|
Query
|
mdae |
Integer |
|
Recommended |
MD Reported AE |
0;1
|
0=No; 1=Yes
|
|
Query
|
bl1_vis |
Integer |
|
Recommended |
Baseline Visit for Phase 1/1A |
0;1
|
0=No; 1=Yes
|
|
Query
|
bl1b_vis |
Integer |
|
Recommended |
Baseline Visit for Phase 1B |
0;1
|
0=No; 1=Yes
|
|
Query
|
bl3_vis |
Integer |
|
Recommended |
Baseline Visit for Phase 3 |
0;1
|
0=No; 1=Yes
|
|
Query
|
bl2_vis |
Integer |
|
Recommended |
Baseline Visit for Phase 2 |
0;1
|
0=No; 1=Yes
|
|
Query
|
bl1_sev |
Integer |
|
Recommended |
Baseline Severity for Phase 1/1A |
0::4
|
0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
|
|
Query
|
bl1b_sev |
Integer |
|
Recommended |
Baseline Severity for Phase 1B |
0::4
|
0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
|
|
Query
|
bl2_sev |
Integer |
|
Recommended |
Baseline Severity for Phase 2 |
0::4
|
0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
|
|
Query
|
bl3_sev |
Integer |
|
Recommended |
Baseline Severity for Phase 3 |
0::4
|
0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
|
|
Query
|
bl1_psv |
Integer |
|
Recommended |
Baseline Patient Severity for Phase 1/1A |
0::4
|
0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
|
|
Query
|
bl1b_psv |
Integer |
|
Recommended |
Baseline Patient Severity for Phase 1B |
0::4
|
0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
|
|
Query
|
bl2_psv |
Integer |
|
Recommended |
Baseline Patient Severity for Phase 2 |
0::4
|
0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
|
|
Query
|
bl3_psv |
Integer |
|
Recommended |
Baseline Patient Severity for Phase 3 |
0::4
|
0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
|
|
Query
|
te1 |
Integer |
|
Recommended |
TE Phase 1/1A |
|
1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
|
|
Query
|
te1b |
Integer |
|
Recommended |
TE Phase 1B |
|
1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
|
|
Query
|
te2 |
Integer |
|
Recommended |
TE Phase 2 |
|
1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
|
|
Query
|
te3 |
Integer |
|
Recommended |
TE Phase 3 |
|
1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
|
|
Query
|
pte1 |
Integer |
|
Recommended |
Patient TE Phase 1/1A |
|
1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
|
|
Query
|
pte1b |
Integer |
|
Recommended |
Patient TE Phase 1B |
|
1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
|
|
Query
|
pte2 |
Integer |
|
Recommended |
Patient TE Phase 2 |
|
1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
|
|
Query
|
pte3 |
Integer |
|
Recommended |
Patient TE Phase 3 |
|
1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
|
|