|
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 :: 1260
|
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
|
tmdisc1 |
Float |
|
Recommended |
Number of months between phase start date and end date in Phase 1/1A |
|
1 month is defined as 28 days
|
|
Query
|
tmdisc1b |
Float |
|
Recommended |
Number of months between phase start date and end date in Phase 1B |
|
1 month is defined as 28 days
|
|
Query
|
tmdisc2 |
Float |
|
Recommended |
Number of months between phase start date and end date in Phase 2 |
|
1 month is defined as 28 days
|
|
Query
|
tmdisc3 |
Float |
|
Recommended |
Number of months between phase start date and end date in Phase 3 |
|
1 month is defined as 28 days
|
|
Query
|
censor1 |
Integer |
|
Recommended |
Censored in Phase 1/1A |
0;1
|
1= if patient completed both the phase and study; 0 otherwise
|
|
Query
|
censor1b |
Integer |
|
Recommended |
Censored in Phase 1B |
0;1
|
1= if patient completed both the phase and study; 0 otherwise
|
|
Query
|
censor2 |
Integer |
|
Recommended |
Censored in Phase 2 |
0;1
|
1= if patient completed both the phase and study; 0 otherwise
|
|
Query
|
trncdur1 |
Integer |
|
Recommended |
P1 patient's duration in phase was truncated to 74 days after the last patient visit |
0;1
|
1= if patient's duration in phase was truncated to 74 days after the last patient visit (necessary for some patients who were lost to follow-up but the site recorded a phase discontinuation date longer than 74 days after last patient contact. 74 days is 2 months after the visit, including a 2-week visit window); missing otherwise
|
|
Query
|
trncdr1b |
Integer |
|
Recommended |
P1B patient's duration in phase was truncated to 74 days after the last patient visit |
0;1
|
1= if patient's duration in phase was truncated to 74 days after the last patient visit (necessary for some patients who were lost to follow-up but the site recorded a phase discontinuation date longer than 74 days after last patient contact. 74 days is 2 months after the visit, including a 2-week visit window); missing otherwise
|
|
Query
|
trncdur2 |
Integer |
|
Recommended |
P2 patient's duration in phase was truncated to 74 days after the last patient visit |
0;1
|
1= if patient's duration in phase was truncated to 74 days after the last patient visit (necessary for some patients who were lost to follow-up but the site recorded a phase discontinuation date longer than 74 days after last patient contact. 74 days is 2 months after the visit, including a 2-week visit window); missing otherwise
|
|
Query
|
dcr_eff1 |
Integer |
|
Recommended |
patient discontinued phase 1/1A due to lack of efficacy |
0;1
|
1= if patient discontinued phase 1/1A due to lack of efficacy; 0 otherwise
|
|
Query
|
dcr_eff2 |
Integer |
|
Recommended |
patient discontinued phase 2 due to lack of efficacy |
0;1
|
1= if patient discontinued phase 2 due to lack of efficacy; 0 otherwise
|
|
Query
|
dcr_tae1 |
Integer |
|
Recommended |
patient discontinued phase 1/1A due to unacceptable side effects |
0;1
|
1= if patient discontinued phase 1/1A due to unacceptable side effects; 0 otherwise
|
|
Query
|
dcr_tae2 |
Integer |
|
Recommended |
patient discontinued phase 2 due to unacceptable side effects |
0;1
|
1= if patient discontinued phase 2 due to unacceptable side effects; 0 otherwise
|
|
Query
|
dcr_pat1 |
Integer |
|
Recommended |
patient discontinued phase 1/1A due to patient/subject advocate's decision |
0;1
|
1= if patient discontinued phase 1/1A due to patient/subject advocate's decision; 0 otherwise
|
|
Query
|
dcr_pat2 |
Integer |
|
Recommended |
patient discontinued phase 2 due to patient/subject advocate's decision |
0;1
|
1= if patient discontinued phase 2 due to patient/subject advocate's decision; 0 otherwise
|
|
Query
|
tmsucc1 |
Integer |
|
Recommended |
Time (months) with Successful Treatment |
|
Number of months in Phase 1/1A patient has CGIS response=1
|
|
Query
|
compeff |
Integer |
|
Recommended |
Composite Ordinal Effectiveness Outcome |
1::5
|
for Phase 1/1A: 1=Completed with improvement; 2=Discontinued with Improvement; 3=Completed w/o improvement; 4=Discontinued w/o Improvement; 5=Discontinued for Safety
|
|
Query
|
dcr_pgo1 |
Integer |
|
Recommended |
P1 patient discontinued phase due to patient/subject advocate's decision AND the patient went on to the next phase |
0;1
|
1= if patient discontinued phase due to patient/subject advocate's decision AND the patient went on to the next phase; 0 otherwise
|
|
Query
|
dcr_pgo2 |
Integer |
|
Recommended |
P2 patient discontinued phase due to patient/subject advocate's decision AND the patient went on to the next phase |
0;1
|
1= if patient discontinued phase due to patient/subject advocate's decision AND the patient went on to the next phase; 0 otherwise
|
|
Query
|
dcr_pst1 |
Integer |
|
Recommended |
1/1A patient discontinued phase due to patient/subject advocate's decision AND the patient terminated the study |
0;1
|
1= if patient discontinued phase due to patient/subject advocate's decision AND the patient terminated the study; 0 otherwise
|
|
Query
|
dcr_pst2 |
Integer |
|
Recommended |
P2 patient discontinued phase due to patient/subject advocate's decision AND the patient terminated the study |
0;1
|
1= if patient discontinued phase due to patient/subject advocate's decision AND the patient terminated the study; 0 otherwise
|
|
Query
|
b1_day |
Integer |
|
Recommended |
Baseline Day - Phase 1/1A |
|
Number of days from study baseline to first day of the phase Based on visit dates
|
|
Query
|
b1b_day |
Integer |
|
Recommended |
Baseline Day - Phase 1B |
|
Number of days from study baseline to first day of the phase Based on visit dates
|
|
Query
|
b2_day |
Integer |
|
Recommended |
Baseline Day - Phase 2 |
|
Number of days from study baseline to first day of the phase Based on visit dates
|
|
Query
|
b3_day |
Integer |
|
Recommended |
Baseline Day - Phase 3 |
|
Number of days from study baseline to first day of the phase Based on visit dates
|
|
Query
|
enddy_1 |
Integer |
|
Recommended |
Number of days from study baseline to end date of phase 1/1A |
|
|
|
Query
|
enddy_1b |
Integer |
|
Recommended |
Number of days from study baseline to end date of phase 1B |
|
|
|
Query
|
enddy_2 |
Integer |
|
Recommended |
Number of days from study baseline to end date of phase 2 |
|
|
|
Query
|
enddy_3 |
Integer |
|
Recommended |
Number of days from study baseline to end date of phase 3 |
|
|
|
Query
|
enddy_s |
Integer |
|
Recommended |
Number of days from study baseline to end date of study |
|
|
|
Query
|
eov03 |
Integer |
|
Recommended |
Was the patient permanently admitted to a nursing home since the last visit? |
0;1
|
0=No; 1=Yes
|
|
Query
|
cva |
Integer |
|
Recommended |
Cerebrovascular Event |
1; 0
|
1=yes,if patient had a CVA; missing otherwise; 0=no
|
|
Query
|
tmcva |
Float |
|
Recommended |
Time (weeks) to Cerebrovascular Event |
|
Weeks from study baseline
|
|
Query
|
tmdeath |
Float |
|
Recommended |
Time (weeks) to Death |
|
Weeks from study baseline
|
|
Query
|
tmnhp |
Float |
|
Recommended |
Time to Nursing Home Placement |
|
Weeks from study baseline
|
|
Query
|
deathdy |
Integer |
|
Recommended |
Day of Death |
|
Number of days from study baseline/randomization to date of death
|
eos04d |
Query
|
fwfa1 |
Integer |
|
Recommended |
Date of study withdrawal |
|
|
eos01a |
Query
|
eos01b |
Integer |
|
Recommended |
Day of withdrawal: |
|
Number of days from study baseline to end of study (withdrawals only)
|
|
Query
|
eov03a |
Integer |
|
Recommended |
If yes, Day of admission: |
|
Number of days from study baseline to date of nursing home admission
|
|
Query
|
death |
Integer |
|
Recommended |
Serious Criteria: Death |
0;1
|
0=No; 1= Yes
|
|