|
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 |
|
|
|
|
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.
|
|
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
|
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
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
|
|
Query
|
aescode |
Integer |
|
Recommended |
Staff code number of person completing this form |
|
999= Missing Data
|
|
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
|
Query
|
days_baseline |
Integer |
|
Recommended |
Days since baseline |
|
|
|
Query
|
amed02 |
Integer |
|
Recommended |
Dose level |
1::4
|
|
cmed02 |
Query
|
amed03 |
Integer |
|
Recommended |
Number of blister card(s) issued |
|
|
cmed03 |
Query
|
amed04 |
Integer |
|
Recommended |
For dose level 1, was patient instructed to skip pills in rows 4, 5, and 6, due to side effects? |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
am4ada |
Integer |
|
Recommended |
If told to skip rows 4, 5, and 6, date (days since baseline) instructed to reduce dosage: |
|
|
|
Query
|
am5da |
Integer |
|
Recommended |
Date (days since baseline) blistercard(s) returned |
|
|
cm4da, rm1da |
Query
|
am6da |
Integer |
|
Recommended |
Date (days since baseline) of first dose |
|
|
cm5da, rm2da |
Query
|
amed06am |
Integer |
|
Recommended |
First dose: time of day |
1::3
|
1 = AM; 2 = noon; 3 = PM
|
cmed05am, rmed02am |
Query
|
ldosedy |
Integer |
|
Recommended |
Day of last dose |
|
Number of days from study baseline to date of last dose
|
cm6da, rm3da |
Query
|
amed07am |
Integer |
|
Recommended |
Last dose: time of day |
1::3
|
1 = AM; 2 = noon; 3 = PM
|
cmed06am, rmed03am |
Query
|
bottle1_disp |
Float |
|
Recommended |
Bottle 1 tablets dispensed |
0::999
|
|
cmed7ds1, rmed4ds1 |
Query
|
bottle1_actual |
Float |
|
Recommended |
Bottle 1 Actual number tablets returned |
0::999
|
|
cmed7rt1, rmed4rt1 |
Query
|
amed7tk1 |
Float |
|
Recommended |
Card 1: Total Tablets Taken |
|
|
cmed7tk1, rmed4tk1 |
Query
|
amed7ms1 |
Float |
|
Recommended |
Card 1: Number Tablets Missing |
|
|
cmed7ms1, rmed4ms1 |
|
amed7re1 |
String |
100
|
Recommended |
Card 1: Reason Missing |
|
|
cmed7re1, rmed4re1 |
Query
|
bottle2_disp |
Float |
|
Recommended |
Bottle 2 tablets dispensed |
0::999
|
|
cmed7ds2, rmed4ds2 |
Query
|
bottle2_actual |
Float |
|
Recommended |
Bottle 2 Actual number returned |
0::999
|
|
cmed7rt2, rmed4rt2 |
Query
|
amed7tk2 |
Float |
|
Recommended |
Card 2: Total Tablets Taken |
|
|
cmed7tk2, rmed4tk2 |
Query
|
amed7ms2 |
Float |
|
Recommended |
Card 2: Number Tablets Missing |
|
|
cmed7ms2, rmed4ms2 |
|
amed7re2 |
String |
100
|
Recommended |
Card 2: Reason Missing |
|
|
cmed7re2, rmed4re2 |
Query
|
bottle3_disp |
Integer |
|
Recommended |
Bottle 3 tablets dispensed |
0::999
|
|
cmed7ds3, rmed4ds3 |
Query
|
bottle3_actual |
Integer |
|
Recommended |
Bottle 3 Actual number tablets returned |
0::999
|
|
cmed7rt3, rmed4rt3 |
Query
|
amed7tk3 |
Integer |
|
Recommended |
Card 3: Total Tablets Taken |
|
|
cmed7tk3, rmed4tk3 |
Query
|
amed7ms3 |
Integer |
|
Recommended |
Card 3: Number Tablets Missing |
|
|
cmed7ms3, rmed4ms3 |
|
amed7re3 |
String |
100
|
Recommended |
Card 3: Reason Missing |
|
|
cmed7re3, rmed4re3 |
Query
|
bottle4_disp |
Integer |
|
Recommended |
Bottle 4 tablets dispensed |
0::999
|
|
cmed7ds4, rmed4ds4 |
Query
|
bottle4_actual |
Integer |
|
Recommended |
Bottle 4 Actual number tablets returned |
0::999
|
|
cmed7rt4, rmed4rt4 |
Query
|
amed7tk4 |
Integer |
|
Recommended |
Card 4: Total Tablets Taken |
|
|
cmed7tk4, rmed4tk4 |
Query
|
amed7ms4 |
Integer |
|
Recommended |
Card 4: Number Tablets Missing |
|
|
cmed7ms4, rmed4ms4 |
|
amed7re4 |
String |
100
|
Recommended |
Card 4: Reason Missing |
|
|
cmed7re4, rmed4re4 |
Query
|
bottle5_disp |
Integer |
|
Recommended |
Bottle 5 tablets dispensed |
0::999
|
|
cmed7ds5, rmed4ds5 |
Query
|
bottle5_actual |
Integer |
|
Recommended |
Bottle 5 Actual number tablets returned |
0::999
|
|
cmed7rt5, rmed4rt5 |
Query
|
amed7tk5 |
Integer |
|
Recommended |
Card 5: Total Tablets Taken |
|
|
cmed7tk5, rmed4tk5 |
Query
|
amed7ms5 |
Integer |
|
Recommended |
Card 5: Number Tablets Missing |
|
|
cmed7ms5, rmed4ms5 |
|
amed7re5 |
String |
100
|
Recommended |
Card 5: Reason Missing |
|
|
cmed7re5, rmed4re5 |
Query
|
bottle6_disp |
Integer |
|
Recommended |
Bottle 6 tablets dispensed |
0::999
|
|
cmed7ds6, rmed4ds6 |
Query
|
bottle6_actual |
Integer |
|
Recommended |
Bottle 6 Actual number tablets returned |
0::999
|
|
cmed7rt6, rmed4rt6 |
Query
|
amed7tk6 |
Integer |
|
Recommended |
Card 6: Total Tablets Taken |
|
|
cmed7tk6, rmed4tk6 |
Query
|
amed7ms6 |
Integer |
|
Recommended |
Card 6: Number Tablets Missing |
|
|
cmed7ms6, rmed4ms6 |
|
amed7re6 |
String |
100
|
Recommended |
Card 6: Reason Missing |
|
|
cmed7re6, rmed4re6 |
Query
|
capsdisp |
Integer |
|
Recommended |
Number of Capsules Dispensed: |
|
|
cmed7ds7, rmed4ds7 |
Query
|
npillret |
Integer |
|
Recommended |
Number of pills returned |
|
999=Legitimately skipped
|
cmed7rt7, rmed4rt7 |
Query
|
amed7tk7 |
Integer |
|
Recommended |
Card 7: Total Tablets Taken |
|
|
cmed7tk7, rmed4tk7 |
Query
|
amed7ms7 |
Integer |
|
Recommended |
Card 7: Number Tablets Missing |
|
|
cmed7ms7, rmed4ms7 |
|
amed7re7 |
String |
100
|
Recommended |
Card 7: Reason Missing |
|
|
cmed7re7, rmed4re7 |
Query
|
asap13b |
Float |
|
Recommended |
If medication dispensed, quantity dispensed (tablet) |
|
|
cmed7ds8, rmed4ds8 |
Query
|
asap14b |
Float |
|
Recommended |
If medication returned, quantity returned (tablet) |
|
|
cmed7rt8, rmed4rt8 |
Query
|
amed7tk8 |
Integer |
|
Recommended |
Card 8: Total Tablets Taken |
|
|
cmed7tk8, rmed4tk8 |
Query
|
amed7ms8 |
Integer |
|
Recommended |
Card 8: Number Tablets Missing |
|
|
cmed7ms8, rmed4ms8 |
|
amed7re8 |
String |
100
|
Recommended |
Card 8: Reason Missing |
|
|
cmed7re8, rmed4re8 |
Query
|
compprot |
Integer |
|
Recommended |
Completed treatment protocol |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
compl3wk |
Integer |
|
Recommended |
Active at Week 3 |
0;1
|
0=No; 1=Yes
|
|
Query
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
|
Query
|
exitrz |
Integer |
|
Recommended |
exit days from randomization |
|
|
|
Query
|
days_discharge |
Integer |
|
Recommended |
Days from baseline to program discharge |
|
|
|
Query
|
study_drug_team |
String |
30
|
Recommended |
Study drug |
|
Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA
|
|
|
medication_name |
String |
255
|
Recommended |
Name of medication |
|
|
|
Query
|
npilltaken |
Float |
|
Recommended |
Number of pills taken |
|
|
|
Query
|
datedose |
Integer |
|
Recommended |
When the last dose was given in days from the randomization date (DATEDOSE = last dose date -
randomization date) |
|
|
|
Query
|
high_dose |
Integer |
|
Recommended |
Experimental higher dose of medication |
|
|
|
Query
|
maxdosedays |
Integer |
|
Recommended |
Days to Maximum Dose |
0::61
|
Number of days between Randomization and first time the Maximum dose of study medication was reached (0-61). Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
mettarget_daysbl |
Integer |
|
Recommended |
Days from Baseline to Target Met |
7::76
|
Met Target Days from Baseline (7-76). Number of days from baseline when target concentration was first met. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
targ1st_days |
Integer |
|
Recommended |
Days to Reach Target |
4::64
|
Number of days between Randomization and first time the Target Concentration was met. (4-64). Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
bloodlv |
Integer |
|
Recommended |
Blood level |
|
|
|
Query
|
maxlevel_days |
Integer |
|
Recommended |
Days to Maximum Study Blood Level |
3::70
|
Number of days between Randomization and first time the Maximum serum level was met. (3-70). Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
risptmt |
String |
10
|
Recommended |
RISP:No,RescueOnly,Adjunct |
|
Text: Risperidone treatment category. NO=No, ADJ=Adjunct, RES=Rescue without Adjunct. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
rispadj |
Integer |
|
Recommended |
Adjunct Risp |
0;1
|
1=Risperidone used 3 weeks or later. 0=Not used 3 weeks+. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
risprescue |
Integer |
|
Recommended |
Rescue Risp |
0;1
|
1=Risperidone used prior to 3 weeks. 0=Not used. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
seg_r |
String |
10
|
Recommended |
Valpro+RispAdj |
|
Category variable: Study drug+Adjunct Risperidone. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
rispactive |
Integer |
|
Recommended |
Risp while active pt |
0;1
|
1= Risperidone used while in protocol. 0= not used while active. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
loraz_tmt |
String |
10
|
Recommended |
Lorazapam Treatment Text |
|
Category of Lorazepam treatment. No, Adjunct, Rescue without Adjunct. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
loraz_3wk |
Integer |
|
Recommended |
Loraz Adj 21days+ |
0;1
|
Patient treated with Lorazapam 3 weeks or later into the protocol (1=y/0=n). Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
loraz_rescue |
Integer |
|
Recommended |
Loraz Resc <21 days |
0;1
|
1= Lorazepam used prior to 3 weeks. 0=Not used. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
rescue_rl |
Integer |
|
Recommended |
Rescue: Risp or Loraz |
0;1
|
1= Risperidol and/or Lorazepam used prior to 3 weeks. 0=Not used prior to 3 weeks. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
adjunct_rl |
Integer |
|
Recommended |
Adjunt Risp or Loraz |
0;1
|
1=Risperidone and/or Lorazepam used in treatment 3 weeks or later. 0=Risperidone and Lorazepam not used post 3 weeks. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
actbdic |
Integer |
|
Recommended |
Active status |
0::5
|
0=Inactive-Data collected after the 14 month treatment phase/after early termination from treatment phase/prior to treatment phase; 1=Active-Data collected during the 14 month treatment phase while subject received originally assigned treatment regardless of degree of compliance; 2=Active-This is the last active assessment for subjects who were about to violate treatment arm by receiving alternate treatment; 3=Active-This is the last active assessment for subjects who were about to leave the study by moving away;4=Yes, Active; 5=No, Not Active
|
|
Query
|
btarget |
Integer |
|
Recommended |
Ever Met Target Concentration On or before this visit Y/N |
0;1
|
Metadata = Visit Information Prefix = B; Visit = Day 0; DAYWK = D0; VISITN = 1; Number of Days in Protocol After Randomization 0; Variables are given a one-letter prefix to denote the time point of the data. Seq 51 - 61. The letter �I� is skipped. 0 = No. TARGET CONCENTRATION: Lithium:0.80-0.99 mEq/L Valpro: 80-99 mcg/ml.; 1 = Yes if target was met on or before this visit. This is a cumulative measure. If a subject met the target concentration at Week 4, for example, then these variables also =1 GTARGET, H ARGET, JTARGET, K TARGET, LTARGET, M TARGET
|
|
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
|
Query
|
me2 |
Integer |
|
Recommended |
Status |
0;1
|
0 = Past [Inactive]; 1 = Active
|
|
Query
|
finaldose |
Integer |
|
Recommended |
Final Dose (number of Pills) |
0::12
|
Final Dose as number of pills per day (0 - 12). Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
maxlevel |
Integer |
|
Recommended |
Maximum Study Blood Level |
5::208
|
Maximum serum blood level brought to common units used in Valproate blood levels. To report Lithium serum blood levels, divide by 100. (Lithium: mEq/L & Valproate: mcg/ml) (5-208). Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
targetmet |
Integer |
|
Recommended |
Target met ever? |
0;1
|
0=Target NOT met; 1=Target met within course of treatment; Target Concentration: Lithium:0.80-0.99 mEq/L Valpro: 80-99 mcg/ml. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
|
|
Query
|
status |
String |
50
|
Recommended |
Status |
|
|
|
Query
|
rreltrt |
Integer |
|
Recommended |
Past treatment |
0::3
|
0 = none;1 = outpatient;2 = inpatient;3 = both
|
|