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Description
Value Range
Notes
Data Structures with shared data
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Medication Logs by Phase

amed

01

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Element NameData TypeSizeRequiredDescriptionValue RangeNotesAliases
subjectkeyGUIDRequiredThe NDAR Global Unique Identifier (GUID) for research subjectNDAR*
src_subject_idString20RequiredSubject ID how it's defined in lab/project
interview_ageIntegerRequiredAge in months at the time of the interview/test/sampling/imaging.0 :: 1260Age 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_dateDateRequiredDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYYRequired field
genderString20RequiredSex of the subjectM;FM = Male; F = Female
visnumFloatRecommendedNumeric 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
aescodeIntegerRecommendedStaff code number of person completing this form
visitString50RecommendedVisit nameCharacter description of each type of visit
days_baselineIntegerRecommendedDays since baseline
amed02IntegerRecommendedDose level1::4cmed02
amed03IntegerRecommendedNumber of blister card(s) issuedcmed03
amed04IntegerRecommendedFor dose level 1, was patient instructed to skip pills in rows 4, 5, and 6, due to side effects?0;10 = No; 1 = Yes
am4adaIntegerRecommendedIf told to skip rows 4, 5, and 6, date (days since baseline) instructed to reduce dosage:
am5daIntegerRecommendedDate (days since baseline) blistercard(s) returnedcm4da, rm1da
am6daIntegerRecommendedDate (days since baseline) of first dosecm5da, rm2da
amed06amIntegerRecommendedFirst dose: time of day1::31 = AM; 2 = noon; 3 = PMcmed05am, rmed02am
ldosedyIntegerRecommendedDay of last doseNumber of days from study baseline to date of last dosecm6da, rm3da
amed07amIntegerRecommendedLast dose: time of day1::31 = AM; 2 = noon; 3 = PMcmed06am, rmed03am
bottle1_dispIntegerRecommendedBottle 1 tablets dispensed0::999cmed7ds1, rmed4ds1
bottle1_actualIntegerRecommendedBottle 1 Actual number tablets returned0::999cmed7rt1, rmed4rt1
amed7tk1IntegerRecommendedCard 1: Total Tablets Takencmed7tk1, rmed4tk1
amed7ms1IntegerRecommendedCard 1: Number Tablets Missingcmed7ms1, rmed4ms1
amed7re1String100RecommendedCard 1: Reason Missingcmed7re1, rmed4re1
bottle2_dispIntegerRecommendedBottle 2 tablets dispensed0::999cmed7ds2, rmed4ds2
bottle2_actualIntegerRecommendedBottle 2 Actual number returned0::999cmed7rt2, rmed4rt2
amed7tk2IntegerRecommendedCard 2: Total Tablets Takencmed7tk2, rmed4tk2
amed7ms2IntegerRecommendedCard 2: Number Tablets Missingcmed7ms2, rmed4ms2
amed7re2String100RecommendedCard 2: Reason Missingcmed7re2, rmed4re2
bottle3_dispIntegerRecommendedBottle 3 tablets dispensed0::999cmed7ds3, rmed4ds3
bottle3_actualIntegerRecommendedBottle 3 Actual number tablets returned0::999cmed7rt3, rmed4rt3
amed7tk3IntegerRecommendedCard 3: Total Tablets Takencmed7tk3, rmed4tk3
amed7ms3IntegerRecommendedCard 3: Number Tablets Missingcmed7ms3, rmed4ms3
amed7re3String100RecommendedCard 3: Reason Missingcmed7re3, rmed4re3
bottle4_dispIntegerRecommendedBottle 4 tablets dispensed0::999cmed7ds4, rmed4ds4
bottle4_actualIntegerRecommendedBottle 4 Actual number tablets returned0::999cmed7rt4, rmed4rt4
amed7tk4IntegerRecommendedCard 4: Total Tablets Takencmed7tk4, rmed4tk4
amed7ms4IntegerRecommendedCard 4: Number Tablets Missingcmed7ms4, rmed4ms4
amed7re4String100RecommendedCard 4: Reason Missingcmed7re4, rmed4re4
bottle5_dispIntegerRecommendedBottle 5 tablets dispensed0::999cmed7ds5, rmed4ds5
bottle5_actualIntegerRecommendedBottle 5 Actual number tablets returned0::999cmed7rt5, rmed4rt5
amed7tk5IntegerRecommendedCard 5: Total Tablets Takencmed7tk5, rmed4tk5
amed7ms5IntegerRecommendedCard 5: Number Tablets Missingcmed7ms5, rmed4ms5
amed7re5String100RecommendedCard 5: Reason Missingcmed7re5, rmed4re5
bottle6_dispIntegerRecommendedBottle 6 tablets dispensed0::999cmed7ds6, rmed4ds6
bottle6_actualIntegerRecommendedBottle 6 Actual number tablets returned0::999cmed7rt6, rmed4rt6
amed7tk6IntegerRecommendedCard 6: Total Tablets Takencmed7tk6, rmed4tk6
amed7ms6IntegerRecommendedCard 6: Number Tablets Missingcmed7ms6, rmed4ms6
amed7re6String100RecommendedCard 6: Reason Missingcmed7re6, rmed4re6
capsdispIntegerRecommendedNumber of Capsules Dispensed:cmed7ds7, rmed4ds7
npillretIntegerRecommendedNumber of pills returned999=Legitimately skippedcmed7rt7, rmed4rt7
amed7tk7IntegerRecommendedCard 7: Total Tablets Takencmed7tk7, rmed4tk7
amed7ms7IntegerRecommendedCard 7: Number Tablets Missingcmed7ms7, rmed4ms7
amed7re7String100RecommendedCard 7: Reason Missingcmed7re7, rmed4re7
asap13bFloatRecommendedIf medication dispensed, quantity dispensed (tablet)cmed7ds8, rmed4ds8
asap14bFloatRecommendedIf medication returned, quantity returned (tablet)cmed7rt8, rmed4rt8
amed7tk8IntegerRecommendedCard 8: Total Tablets Takencmed7tk8, rmed4tk8
amed7ms8IntegerRecommendedCard 8: Number Tablets Missingcmed7ms8, rmed4ms8
amed7re8String100RecommendedCard 8: Reason Missingcmed7re8, rmed4re8
compprotIntegerRecommendedCompleted treatment protocol0;1;-70=No; 1=Yes; -7=Refused
compl3wkIntegerRecommendedActive at Week 30;10=No; 1=Yes
visdayIntegerRecommendedNumber of days from study baseline to date of visit
exitrzIntegerRecommendedexit days from randomization
days_dischargeIntegerRecommendedDays from baseline to program discharge
study_drug_teamString30RecommendedStudy drugBaseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA
medication_nameString255RecommendedName of medication
npilltakenFloatRecommendedNumber of pills taken
datedoseIntegerRecommendedWhen the last dose was given in days from the randomization date (DATEDOSE = last dose date - randomization date)
high_doseIntegerRecommendedExperimental higher dose of medication
maxdosedaysIntegerRecommendedDays to Maximum Dose0::61Number 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.
mettarget_daysblIntegerRecommendedDays from Baseline to Target Met7::76Met 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.
targ1st_daysIntegerRecommendedDays to Reach Target4::64Number 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.
bloodlvIntegerRecommendedBlood level
maxlevel_daysIntegerRecommendedDays to Maximum Study Blood Level3::70Number 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.
risptmtString10RecommendedRISP:No,RescueOnly,AdjunctText: 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.
rispadjIntegerRecommendedAdjunct Risp0;11=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.
risprescueIntegerRecommendedRescue Risp0;11=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.
seg_rString10RecommendedValpro+RispAdjCategory variable: Study drug+Adjunct Risperidone. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
rispactiveIntegerRecommendedRisp while active pt0;11= 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.
loraz_tmtString10RecommendedLorazapam Treatment TextCategory 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.
loraz_3wkIntegerRecommendedLoraz Adj 21days+0;1Patient 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.
loraz_rescueIntegerRecommendedLoraz Resc <21 days0;11= 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.
rescue_rlIntegerRecommendedRescue: Risp or Loraz0;11= 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.
adjunct_rlIntegerRecommendedAdjunt Risp or Loraz0;11=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.
actbdicIntegerRecommendedActive status0::50=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
btargetIntegerRecommendedEver Met Target Concentration On or before this visit Y/N0;1Metadata = 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
siteString100RecommendedSiteStudy Site
me2IntegerRecommendedStatus0;10 = Past [Inactive]; 1 = Active
finaldoseIntegerRecommendedFinal Dose (number of Pills)0::12Final 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.
maxlevelIntegerRecommendedMaximum Study Blood Level5::208Maximum 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.
targetmetIntegerRecommendedTarget met ever?0;10=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.
statusString50RecommendedStatus
rreltrtIntegerRecommendedPast treatment0::30 = none;1 = outpatient;2 = inpatient;3 = both
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
  • For valid elements with shared data, on the far left is a Filter button you can use to view a summary of shared data for that element and apply a query filter to your Cart based on selected value ranges

At the top of this page you can also:

  • Use the search bar to filter the elements displayed. This will not filter on the Size of Required columns
  • Download a copy of this definition in CSV format
  • Download a blank CSV submission template prepopulated with the correct structure header rows ready to fill with subject records and upload

Please email the The NDA Help Desk with any questions.

Distribution for DataStructure: amed01 and Element:
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