|
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 |
|
|
patid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
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|
|
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
|
race |
String |
30
|
Recommended |
Race of study subject |
American Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reported; Other Non-White; Other
|
|
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Query
|
elig_criteria |
Integer |
|
Recommended |
Did patient meet all eligibility criteria? |
1::4
|
1 = Yes 2 = No (waiver) 3 = No (excluded) 4 = Unsure
|
criteria |
Query
|
age_c |
Integer |
|
Recommended |
Patient age at study start (based on Gate C2 date or IVRS enrollment date if Gate C2 date not available) |
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|
Query
|
age_a |
Integer |
|
Recommended |
Patient age at Gate A screening |
|
|
|
Query
|
age_b |
Integer |
|
Recommended |
Patient age at Gate B1 procedures date |
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|
Query
|
txnum |
Integer |
|
Recommended |
Randomized treatment |
1::4
|
1 = Fluoxetine (FLX) 2 = Cognitive BehavioralTherapy (CBT) only 3 = CBT and FLX Combination (COMB) 4 = Placebo (PBO)
|
|
Query
|
txcode |
String |
10
|
Recommended |
Character coding for treatment assignment |
COMB; FLX; CBT; PBO
|
Fluoxetine (FLX) Cognitive BehavioralTherapy (CBT) only CBT and FLX Combination (COMB) Placebo (PBO)
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Query
|
studydrp |
Integer |
|
Recommended |
Indicator for Study Dropout |
0::4
|
0 = No 1 = Yes, Stage I 2 = Yes, Stage II 3 = Yes, Stage III 4 = Yes, Stage IV
|
|
Query
|
lasstyp |
Integer |
|
Recommended |
Last assessment completed - if the patient was a study dropout, this represents the last assessment completed prior to dropping out of the study, otherwise it represents the last time period where primary endpoint data (CDRS and CGI scores) was collected |
3::13
|
3 = Gate C1; 4 = Week 6; 5 = Week 12; 6 = Week 18; 7 = Week 24; 8 = Week 30; 9 = Week 36; 10 = Month 3; 11 = Month 6; 12 = Month 9; 13 = Month 12
|
|
Query
|
studypmt |
Integer |
|
Recommended |
Stage I - III: Premature termination indicator [Note: The patient cannot have a premature termination in Stage IV] |
0::3
|
0 = No 1 = Yes, Stage I 2 = Yes, Stage II 3 = Yes, Stage III
|
|
Query
|
pmtlasst |
Integer |
|
Recommended |
Stage I - III: Last assessment completed prior to premature termination [Note: The patient cannot have a premature termination in Stage IV] |
3::8
|
3 = Gate C1; 4 = Week 6; 5 = Week 12; 6 = Week 18; 7 = Week 24; 8 = Week 30
|
|
Query
|
wk6comp |
Integer |
|
Recommended |
Indicator for Week 6 visit completed - based on presence of CDRS or CGI forms for Week 6 |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
wk12comp |
Integer |
|
Recommended |
Indicator for Week 12 visit completed - based on presence of CDRS or CGI forms for Week 12 |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
wk18comp |
Integer |
|
Recommended |
Indicator for Week 18 visit completed based on presence of CDRS or CGI forms for Week 18 |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
wk24comp |
Integer |
|
Recommended |
Indicator for Week 24 visit completed - based on presence of CDRS or CGI forms for Week 24 |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
wk30comp |
Integer |
|
Recommended |
Indicator for Week 30 visit completed based on presence of CDRS or CGI forms for Week 30 |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
wk36comp |
Integer |
|
Recommended |
Indicator for Week 36 visit completed - based on presence of CDRS or CGI forms for Week 36 |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
mo3comp |
Integer |
|
Recommended |
Indicator for Month 3 visit completed based on presence of CDRS or CGI forms for Month 3 |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
mo6comp |
Integer |
|
Recommended |
Indicator for Month 6 visit completed - based on presence of CDRS or CGI forms for Month 6 |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
mo9comp |
Integer |
|
Recommended |
Indicator for Month 9 visit completed - based on presence of CDRS or CGI forms for Month 9 |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
mo12comp |
Integer |
|
Recommended |
Indicator for Month 12 visit completed - based on presence of CDRS or CGI forms for Month 12 |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
completr |
Integer |
|
Recommended |
Stage I: Stage I completer population, defined as completed a Week 12 assessment while in the randomized arm (did not dropout or prematurely terminate prior to Week 12). |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
pmtt0 |
Float |
|
Recommended |
Stage I - III: Weeks from Time 0 to premature termination |
|
|
|
Query
|
sdot0 |
Float |
|
Recommended |
Weeks from Time 0 to last assessment or treatment session |
|
|
|
Query
|
pstpmttx |
String |
10
|
Recommended |
Stage I: Post-PMT TADS treatment received (only for patients that prematurely terminated) during Stage I |
COMB; FLX; CBT; NONE
|
Fluoxetine (FLX) Cognitive BehavioralTherapy (CBT) only CBT and FLX Combination (COMB) None
|
|
Query
|
lpmtwk1 |
Integer |
|
Recommended |
Stage I: Premature termination timing: This represents the last study week in which the teen started the week in the assigned arm (pre-PMT). Only available for those patients that prematurely terminated in Stage I. |
1::12;99
|
99 = Stage I > 12 weeks
|
|
Query
|
lsdowk1 |
Integer |
|
Recommended |
Stage I: Study dropout timing: This variable represents the last study week in which the teen started the week as a non-dropout. Only available for those patients that dropped out of the study during Stage I. |
1::12;99
|
99 = Stage I > 12 weeks
|
|
Query
|
lpmtsdo1 |
Integer |
|
Recommended |
Stage I: Premature termination or study dropout timing: This variable represents the last study week in which the teen started the week as an active participant in the assigned treatment arm. Only available for those patients that prematurely terminated or dropped out of the study during Stage I. |
1::12;99
|
99 = Stage I > 12 weeks
|
|
Query
|
s1txsw |
Integer |
|
Recommended |
Stage I: End of Stage I Treatment switch flag. Stage I study dropout or PMT or final CGIt-I value > 3 considered to have not continued in randomized treatment arm at the end of Stage I for patients in the active treatment arm. |
0::2
|
0 = FLX, CBT, & COMB arms: Did not continue in randomized treatment arm; 1 = FLX, CBT, & COMB arms: Continued in randomized treatment arm; 2 = PBO patient
|
|
Query
|
oclastt0 |
Float |
|
Recommended |
Stage I - III: Observed Cases: Weeks from randomization to last treatment session date or assessment date based on premature termination/study dropout status and coded value for Stage I treatment switch flag. This applies to Stages I through III only. |
|
|
|
Query
|
oclastas |
Integer |
|
Recommended |
Stage I - III: Observed Cases: Last assessment visit based on premature termination/study dropout status and coded value for Stage I treatment switch flag. This applies to Stages I through III only. |
1::9
|
3 = Gate C1; 4 = Week 6; 5 = Week 12; 6 = Week 18; 7 = Week 24; 8 = Week 30; 9 = Week 36
|
|
Query
|
lpmtwk3 |
Integer |
|
Recommended |
Stage I - III: Premature termination timing: This represents the last study week in which the teen started the week in the assigned arm (pre-PMT). This is counting the true number of weeks from Time 0 regardless of Week 12, Week 18 or Week 36 timing.Only available for those patients that prematurely terminated in Stage I through Stage III. |
1::36;99
|
99 = > 36 weeks
|
|
Query
|
lsdowk3 |
Integer |
|
Recommended |
Stage I - III: Study dropout timing: This variable represents the last study week in which the teen started the week as a non-dropout. This is counting the true number of weeks from Time 0 regardless of Week 12, Week 18 or Week 36 timing.Only available for those patients that dropped out of the study during Stage I through Stage III. |
1::36;99
|
99 = > 36 weeks
|
|
Query
|
lpmtsdo3 |
Integer |
|
Recommended |
Stage I - III: Premature termination or study dropout timing: This variable represents the last study week in which the teen started the week as an active participant in the assigned treatment arm. This is counting the true number of weeks from Time 0 regardless of Week 12, Week 18 or Week 36 timing.Only available for those patients that prematurely terminated or dropped out of the study during Stage I through Stage III. |
1::36;99
|
99 = > 36 weeks
|
|
Query
|
lsdowk4 |
Integer |
|
Recommended |
Stage I - IV: Study dropout timing: This variable represents the last study week in which the teen started the week as a non-dropout. This is counting the true number of weeks from Time 0 regardless of Week 12, Week 18, Week 36 orMonth 12 timing.Only available for those patients that dropped out in Stage I through Stage IV. |
1::88;99
|
99 = > 88 weeks
|
|
Query
|
ethnicity |
String |
30
|
Recommended |
Ethnicity of participant |
|
|
|
Query
|
stcomp |
Integer |
|
Recommended |
Stage V: SOFTAD study completion status |
1;2
|
1 = Completed SOFTAD month 42; 2 = Dropped out of SOFTAD before month 42
|
|
Query
|
stlast |
Integer |
|
Recommended |
Stage V: SOFTAD last assessment |
14::20
|
14 = SOFTAD month 6; 15 = SOFTAD month 12; 16 = SOFTAD month 18; 17 = SOFTAD month 24; 18 = SOFTAD month 30; 19 = SOFTAD month 36; 20 = SOFTAD month 42
|
|
Query
|
age_e |
Float |
|
Recommended |
Stage V: Age at SOFTAD enrollment visit |
|
|
|
Query
|
stlastmo |
Float |
|
Recommended |
Stage V: Mos., TADS Time0 last asst. |
|
|
|
Query
|
stlast_m |
Float |
|
Recommended |
Stage V: Mos., SOFTAD enr. - last asst. |
|
|
|
Query
|
stdor1 |
Integer |
|
Recommended |
Dropout -subject moved and participation is no longer possible |
0;1
|
1 = Yes; 0=No
|
|
Query
|
stdor2 |
Integer |
|
Recommended |
Dropout - lost to follow-up |
1;0
|
1 = Yes; 0=No
|
|
Query
|
stdor3 |
Integer |
|
Recommended |
Dropout-consent withdrawn |
1;0
|
1 = Yes; 0-No
|
|
Query
|
stdor4 |
Integer |
|
Recommended |
Stage V: Dropout-teen pregnancyTeen is pregnant |
1
|
1 = Yes
|
|
Query
|
stdor5 |
Integer |
|
Recommended |
Dropout-adverse event |
1;0
|
1 = Yes; 0=No
|
|
Query
|
stdor6 |
Integer |
|
Recommended |
Dropout-subject' death |
1;0
|
1 = Yes; 0=No
|
|
Query
|
stdor7 |
Integer |
|
Recommended |
Dropout-other reason |
1;0
|
1 = Yes; 0=No
|
|
Query
|
stdor8 |
Integer |
|
Recommended |
Dropout-unknown reason |
1;0
|
1 = Yes; 0=No
|
|
Query
|
stdor3_s |
String |
100
|
Recommended |
Stage V: Dropout-consent withdrawn, sp. |
|
|
|
|
stdor5_s |
String |
40
|
Recommended |
Stage V: Dropout-adverse event, spec. |
|
|
|
|
stdor6_s |
String |
40
|
Recommended |
Stage V: Dropout-death, spec. |
|
|
|
Query
|
stdor7_s |
String |
255
|
Recommended |
Stage V: Dropout-other reason, spec. |
|
|
|
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
enr_vis |
Query
|
enr_ast |
Integer |
|
Recommended |
SOFTAD enrollment assessment type |
14::20
|
|
|
Query
|
ste_m |
Float |
|
Recommended |
SOFTAD enrollment: mos. from TADS Time0 |
|
|
|