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Description
Value Range
Notes
Data Structures with shared data
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Dose Compliance Variables

dosecomp

01

Clinical Trials: Dose, compliance variables

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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/projectCATIEID
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
visitidIntegerRecommendedMetaTrial Visit IDSystem variable: unique code for each type of visit -use to merge files
visitString50RecommendedVisit nameCharacter description of each type of visit
truncvisIntegerRecommendedTruncated Visit NumberCreated variable: provides a numeric visit number for all visits, including unscheduled and end of phase
phase_ctString20RecommendedCurrent 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
visdayIntegerRecommendedNumber of days from study baseline to date of visit
medad01String10RecommendedWhat Phase was the patient in at the beginning1 or 1A; 1B; 2; 3; 44=Open-Choicemadh01
medad03FloatRecommendedProportion of capsules takenA calculation done by the site of the proportion of prescribed capsules since the previous visit that were taken, based on pill count in the returned bottle. (This is a pill count estimate of compliance since the previous visit, and requires the patient to return the bottle) This field is only applicable to double-blind treatments (Phase 1/1a, Phase 2 except for Clozapine)
medad06IntegerRecommendedNumber of capsules prescribed per dayPrescribed dose since the previous visit. Patients could be prescribed between 1 and 4 double-blind capsules per day. This field is only applicable to double-blind treatment visits (Phase 1/1a, Phase 2 except for Clozapine)
medad07IntegerRecommendedFor Phase 2 open-label Clozapine, dayThis field is only applicable for Phase 2 visits for patients on Clozapine. Prescribed dose since the previous visit (mg).
msa04IntegerRecommendedhas patient taken medication using dosage frequency by QTONE?0;10=No; 1=Yes; Indicates if patients were instructed to take medication using the randomized dosing regimen, which is either QD - once per day or BID - twice per day. This field is only applicable to double-blind treatment visits (Phase 1/1a, Phase 2 except for Clozapine)
msa04bIntegerRecommendedif no, the patient is taking the study medication1;21= QD; 2= BID. This field is only applicable to double-blind treatment visits (Phase 1/1a, Phase 2 except for Clozapine)
medad08IntegerRecommendedMedication 11::81=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone;5= Perphenazine; 6=Clozapine; 7=Fluephenazine-D; 8=Aripiprazole
medad10FloatRecommendedPrescribed dose since last visitThis field is only applicable to Phase 3 open-label visits
medad11IntegerRecommendedMedication 21::81=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone;5= Perphenazine; 6=Clozapine; 7=Fluephenazine-D; 8=Aripiprazole
medad13FloatRecommendedPrescribed dose since last visitThis field is only applicable to Phase 3 open-label visits
medad14IntegerRecommendedClinical Global Judgment of Medication A1::41=Always/Almost always [76-100% of the time]; 2=Usually [51-75% of the time]; 3=Sometimes [26-50% of the time]; 4=Never/Almost never [0-25% of the time]
capsulesFloatRecommendedNumber of Capsules Prescribed/Day Since Last VisitNumber of capsules prescribed/day since the last visit=MEDAD06
dose1FloatRecommendedPrescribed Daily Dose in P1 (mg)# of capsules prescribed per day since the last visit multiplied by the capsule strength of treatment. Capsule strength is as follows: OLZ: 7.5 mg; QUET: 200 mg; RISP: 1.5 mg; PER: 8 mg; ZIP: 40 mg. Note: This is the dose in mg. This field does not contain the actual treatment assignment. Treatment assignments are not contained in this file - see file KEYVARS.
dose2FloatRecommendedPrescribed Daily Dose in P2 (mg)# of capsules prescribed per day since the last visit multiplied by the capsule strength of treatment. Capsule strength is as follows: OLZ: 7.5 mg; QUET: 200 mg; RISP: 1.5 mg; ZIP: 40 mg. CLOZ: as reported in variable MEDAD07. Note: This is the dose in mg. This field does not contain the actual treatment assignment. Treatment assignments are not contained in this file - see file KEYVARS.
dose3FloatRecommendedPrescribed Daily Dose in P3 (mg)As reported in variables MEDAD10 (first Phase 3 treatment) and MEDAD13 (second Phase 3 treatment). Missing if patient was receiving Dual treatment.
presreg1IntegerRecommendedP1 Prescribed Dosing Regimen1;21= Once a Day (BID); 2= Twice a Day (QD). This is usually equal to the randomized dosing regimen in Phase 1/1a (see file KEYVARS for randomized dosing regimen variable), but if a patient was ever switched to a different regimen, (per MSA04 and MSA04B), then this takes the value of the regimen the patient was switched to. Value is stored on the first record per patient
presreg2IntegerRecommendedP2 Prescribed Dosing Regimen1::31= Once a Day (BID); 2= Twice a Day (QD); 3=none (for clozapine). This is usually equal to the randomized dosing regimen in Phase 2 (see file KEYVARS for randomized dosing regimen variable), but if a patient was ever switched to a different regimen, (per MSA04 and MSA04B), then this takes the value of the regimen the patient was switched to. Value is stored on the first record per patient
avgcaps1FloatRecommendedAverage number of capsules prescribed/day across phase 1/1A (mg)Value is stored on the first record per patient
avgdose1FloatRecommendedAverage prescribed daily dose across phase 1/1a (mg)Value is stored on the first record per patient
moddose1FloatRecommendedModal prescribed daily dose across phase 1/1a (mg)Value is stored on the first record per patient
catcaps1IntegerRecommendedAverage Number of Capsiles Prescribed Across P1 (Cat)1::4categorized version of AVGCAPS1 1= 1 capsule; 2= 2 capsules; 3= 3 capsules; 4= 4 capsules. Value is stored on the first record per patient
avgcaps2FloatRecommendedAverage Number of Capsiles Prescribed Across P2Average number of capsules prescribed/day across phase 2. Value is stored on the first record per patient
avgdose2FloatRecommendedAverage Prescribed Dose Across P2 (mg)Average prescribed daily dose across phase 2 Value is stored on the first record per patient
moddose2FloatRecommendedModal Prescribed Dose Across P2 (mg)Modal prescribed daily dose across phase 2 Value is stored on the first record per patient
catcaps2IntegerRecommendedAverage Number of Capsiles Prescribed Across P2 (Cat)1::5categorized version of AVGCAPS2 1= 1 capsule; 2= 2 capsules; 3= 3 capsules; 4= 4 capsules; 5= 5 capsules. Value is stored on the first record per patient
avgdose3FloatRecommendedAverage Prescribed Dose Across P3(mg)Average prescribed daily dose across phase 3 Not defined for patients on Dual medication in P3 Value is stored on the first record per patient
moddose3FloatRecommendedModal Prescribed Dose Across P3 (mg)Modal prescribed daily dose across phase 3. Not defined for patients on Dual medication in P3 Value is stored on the first record per patient
max1IntegerRecommendedFlag: Max # Capsules Prescribed in P10;11=Yes at one record which has the maximum value of CAPSULES in phase 1/1a
max2IntegerRecommendedFlag: Max # Capsules Prescribed in P20;11=Yes at one record which has the maximum value of CAPSULES (or Clozapine dose) in phase 2
max3IntegerRecommendedFlag: Max Dose Prescribed in P30;11=Yes at one record which has the maximum dose in phase 3. Not defined for patients on Dual medication in P3
madh12aIntegerRecommendedNum of std caps prscrbd snce vis hi
madh12bIntegerRecommendedNum of std caps prscrbd snce vis low
madh13FloatRecommendedFor Phase 3, open- label daily dose p
treat_1IntegerRecommendedTreatment for Phase 11::81=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine;7= Citalopram; 8=Placebo
treat2IntegerRecommendedTreatment for Phase 2E/2T1::81=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine; 7= Citalopram; 8=Placebo
treat_3IntegerRecommendedTreatment for Phase 3 (Combined)1::9Contains treatment assigned in Phase 3. If patient was only assigned one drug in this phase, the drug name is listed. If a patient was assigned 2 drugs in Phase 3, this variable takes the value of Dual.1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine; 7=Aripiprazole; 8=Fluphenazine; 9=Dual
dur_1FloatRecommendedDuration in Phase 1 (weeks)
dur_2FloatRecommendedDuration in Phase 2 (weeks)
dur_3FloatRecommendedDuration in Phase 3 (weeks)
lowdoseFloatRecommended# Low Dose Caps * Treatment Dose# of low dose capsules prescribed per day multiplied by the capsule strength of treatment OLZ: 2.5 mg QUET: 25 mg RISP: 0.5 mg CIT: 10 mg
highdoseIntegerRecommended# High Dose Caps * Treatment Dose# of high dose capsules prescribed per day multiplied by the capsule strength of treatment OLZ: 5 mg QUET: 50 mg RISP: 1 mg CIT: 20 mg
doseFloatRecommendedPrescribed Dose in Phase (mg)Combination of highdose and lowdose for phases 1 and 2, or as reported in variable MADH13 for phase 3
first_dIntegerRecommendedFlag: 1st Non-Miss Prescribed Dose in Ph11=Yes for all records meeting this criteria
last_dIntegerRecommendedFlag: Last Prescribed Dose in Phase11=Yes for all records meeting this criteria
first_cIntegerRecommendedFlag: First Caps Prscbd in HighDose in P11=Yes for all records meeting this criteria
last_cIntegerRecommendedFlag: Last Caps Prscbd in HighDose in Ph11=Yes for all records meeting this criteria
first_vIntegerRecommendedFlag: First Visit in Phase11=Yes for all records meeting this criteria
last_vIntegerRecommendedFlag: Last Visit in Phase11=Yes for all records meeting this criteria
dse_adj1IntegerRecommendedPatient Adjusted (Inc) Dose (#Caps): P10;11=Yes if patient increased the number of capsules in phase; missing otherwise
dse_adj2IntegerRecommendedPatient Adjusted (Inc) Dose (#Caps): P20;11=Yes if patient increased the number of capsules in phase; missing otherwise
compl_1FloatRecommendedTreatment Compliance (%) Across All VisitsCompliance in Phase 1
compl_1cIntegerRecommendedTreatment Compliance (Categorized) Across1;2;31 = < 76%; 2 = 76-100%; 3 = > 100%
compl_2FloatRecommendedTreatment Compliance (%) Across All VisitsCompliance in Phase 2
compl_2cIntegerRecommendedTreatment Compliance (Categorized) Across1;2;31 = < 76%; 2 = 76-100%; 3 = > 100%
compl_3FloatRecommendedTreatment Compliance (%) Across All VisitsCompliance in Phase 3
compl_3cIntegerRecommendedTreatment Compliance (Categorized) Across1 = < 76%; 2 = 76-100%; 3 = > 100%
b1_dayIntegerRecommendedBaseline Day - Phase 1/1ANumber of days from study baseline to first day of the phase Based on visit dates
b2_dayIntegerRecommendedBaseline Day - Phase 2Number of days from study baseline to first day of the phase Based on visit dates
b3_dayIntegerRecommendedBaseline Day - Phase 3Number of days from study baseline to first day of the phase Based on visit dates
boc_dayIntegerRecommendedBaseline Visit Day- Open Choice PhaseNumber of days from study baseline to start date of phase
e1_dayIntegerRecommendedDay Discontinued from Phase 1/1ANumber of days from study baseline to date of phase discontinuation Based on visit dates
e2_dayIntegerRecommendedDay Discontinued from Phase 2Number of days from study baseline to date of phase discontinuation Based on visit dates
e3_dayIntegerRecommendedDay Discontinued from Phase 3Number of days from study baseline to date of phase discontinuation Based on visit dates
eoc_dayIntegerRecommendedVisit Day Discontinued from Open ChoiceNumber of days from study baseline to end date of phase
es_dayIntegerRecommendedDay Discontinued from StudyNumber of days from study baseline to date of study discontinuation (excluding follow-up phase) Based on visit dates
b3_cgicIntegerRecommendedPhase 3 Baseline CGIC
b3_respIntegerRecommendedPhase 3 Baseline CGIC Response
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:

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  • Size: If applicable, the character limit of this element
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  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
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Distribution for DataStructure: dosecomp01 and Element:
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