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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Dose Compliance Variables

1,881 Shared Subjects

Clinical Trials: Dose, compliance variables
Clinical Assessments
Summary
05/07/2014
dosecomp01
05/07/2014
View Change History
01
Definition
Submission Template
Query Element Name Data Type Size Required Description Value Range Notes Aliases
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_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 visitid Integer Recommended MetaTrial Visit ID System variable: unique code for each type of visit -use to merge files
Query visit String 60 Recommended Visit name
Query truncvis Integer Recommended Truncated Visit Number Created variable: provides a numeric visit number for all visits, including unscheduled and end of phase
Query phase_ct String 20 Recommended Current 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
Query visday Integer Recommended Number of days from study baseline to date of visit
Query medad01 String 10 Recommended What Phase was the patient in at the beginning 1 or 1A; 1B; 2; 3; 4 4=Open-Choice madh01
Query medad03 Float Recommended Proportion of capsules taken A 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)
Query medad06 Integer Recommended Number of capsules prescribed per day Prescribed 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)
Query medad07 Integer Recommended For Phase 2 open-label Clozapine, day This field is only applicable for Phase 2 visits for patients on Clozapine. Prescribed dose since the previous visit (mg).
Query msa04 Integer Recommended has patient taken medication using dosage frequency by QTONE? 0;1 0=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)
Query msa04b Integer Recommended if no, the patient is taking the study medication 1;2 1= QD; 2= BID. This field is only applicable to double-blind treatment visits (Phase 1/1a, Phase 2 except for Clozapine)
Query medad08 Integer Recommended Medication 1 1::8 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone;5= Perphenazine; 6=Clozapine; 7=Fluephenazine-D; 8=Aripiprazole
Query medad10 Float Recommended Prescribed dose since last visit This field is only applicable to Phase 3 open-label visits
Query medad11 Integer Recommended Medication 2 1::8 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone;5= Perphenazine; 6=Clozapine; 7=Fluephenazine-D; 8=Aripiprazole
Query medad13 Float Recommended Prescribed dose since last visit This field is only applicable to Phase 3 open-label visits
Query medad14 Integer Recommended Clinical Global Judgment of Medication A 1::4 1=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]
Query capsules Float Recommended Number of Capsules Prescribed/Day Since Last Visit Number of capsules prescribed/day since the last visit=MEDAD06
Query dose1 Float Recommended Prescribed 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.
Query dose2 Float Recommended Prescribed 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.
Query dose3 Float Recommended Prescribed 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.
Query presreg1 Integer Recommended P1 Prescribed Dosing Regimen 1;2 1= 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
Query presreg2 Integer Recommended P2 Prescribed Dosing Regimen 1::3 1= 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
Query avgcaps1 Float Recommended Average number of capsules prescribed/day across phase 1/1A (mg) Value is stored on the first record per patient
Query avgdose1 Float Recommended Average prescribed daily dose across phase 1/1a (mg) Value is stored on the first record per patient
Query moddose1 Float Recommended Modal prescribed daily dose across phase 1/1a (mg) Value is stored on the first record per patient
Query catcaps1 Integer Recommended Average Number of Capsiles Prescribed Across P1 (Cat) 1::4 categorized version of AVGCAPS1 1= 1 capsule; 2= 2 capsules; 3= 3 capsules; 4= 4 capsules. Value is stored on the first record per patient
Query avgcaps2 Float Recommended Average Number of Capsiles Prescribed Across P2 Average number of capsules prescribed/day across phase 2. Value is stored on the first record per patient
Query avgdose2 Float Recommended Average Prescribed Dose Across P2 (mg) Average prescribed daily dose across phase 2 Value is stored on the first record per patient
Query moddose2 Float Recommended Modal Prescribed Dose Across P2 (mg) Modal prescribed daily dose across phase 2 Value is stored on the first record per patient
Query catcaps2 Integer Recommended Average Number of Capsiles Prescribed Across P2 (Cat) 1::5 categorized 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
Query avgdose3 Float Recommended Average 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
Query moddose3 Float Recommended Modal 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
Query max1 Integer Recommended Flag: Max # Capsules Prescribed in P1 0;1 1=Yes at one record which has the maximum value of CAPSULES in phase 1/1a
Query max2 Integer Recommended Flag: Max # Capsules Prescribed in P2 0;1 1=Yes at one record which has the maximum value of CAPSULES (or Clozapine dose) in phase 2
Query max3 Integer Recommended Flag: Max Dose Prescribed in P3 0;1 1=Yes at one record which has the maximum dose in phase 3. Not defined for patients on Dual medication in P3
Query madh12a Integer Recommended Num of std caps prscrbd snce vis hi
Query madh12b Integer Recommended Num of std caps prscrbd snce vis low
Query madh13 Float Recommended For Phase 3, open- label daily dose p
Query treat_1 Integer Recommended Treatment for Phase 1 1::8 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine;7= Citalopram; 8=Placebo
Query treat2 Integer Recommended Treatment for Phase 2E/2T 1::8 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine; 7= Citalopram; 8=Placebo
Query treat_3 Integer Recommended Treatment for Phase 3 (Combined) 1::9 Contains 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
Query dur_1 Float Recommended Duration in Phase 1 (weeks)
Query dur_2 Float Recommended Duration in Phase 2 (weeks)
Query dur_3 Float Recommended Duration in Phase 3 (weeks)
Query lowdose Float Recommended # 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
Query highdose Integer Recommended # 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
Query dose Float Recommended Prescribed Dose in Phase (mg)
Query first_d Integer Recommended Flag: 1st Non-Miss Prescribed Dose in Ph 1 1=Yes for all records meeting this criteria
Query last_d Integer Recommended Flag: Last Prescribed Dose in Phase 1 1=Yes for all records meeting this criteria
Query first_c Integer Recommended Flag: First Caps Prscbd in HighDose in P 1 1=Yes for all records meeting this criteria
Query last_c Integer Recommended Flag: Last Caps Prscbd in HighDose in Ph 1 1=Yes for all records meeting this criteria
Query first_v Integer Recommended Flag: First Visit in Phase 1 1=Yes for all records meeting this criteria
Query last_v Integer Recommended Flag: Last Visit in Phase 1 1=Yes for all records meeting this criteria
Query dse_adj1 Integer Recommended Patient Adjusted (Inc) Dose (#Caps): P1 0;1 1=Yes if patient increased the number of capsules in phase; missing otherwise
Query dse_adj2 Integer Recommended Patient Adjusted (Inc) Dose (#Caps): P2 0;1 1=Yes if patient increased the number of capsules in phase; missing otherwise
Query compl_1 Float Recommended Treatment Compliance (%) Across All Visits Compliance in Phase 1
Query compl_1c Integer Recommended Treatment Compliance (Categorized) Across 1;2;3 1 = < 76%; 2 = 76-100%; 3 = > 100%
Query compl_2 Float Recommended Treatment Compliance (%) Across All Visits Compliance in Phase 2
Query compl_2c Integer Recommended Treatment Compliance (Categorized) Across 1;2;3 1 = < 76%; 2 = 76-100%; 3 = > 100%
Query compl_3 Float Recommended Treatment Compliance (%) Across All Visits Compliance in Phase 3
Query compl_3c Integer Recommended Treatment Compliance (Categorized) Across 1 = < 76%; 2 = 76-100%; 3 = > 100%
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 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 boc_day Integer Recommended Baseline Visit Day- Open Choice Phase Number of days from study baseline to start date of phase
Query e1_day Integer Recommended Day Discontinued from Phase 1/1A Number of days from study baseline to date of phase discontinuation Based on visit dates
Query e2_day Integer Recommended Day Discontinued from Phase 2 Number of days from study baseline to date of phase discontinuation Based on visit dates
Query e3_day Integer Recommended Day Discontinued from Phase 3 Number of days from study baseline to date of phase discontinuation Based on visit dates
Query eoc_day Integer Recommended Visit Day Discontinued from Open Choice Number of days from study baseline to end date of phase
Query es_day Integer Recommended Day Discontinued from Study Number of days from study baseline to date of study discontinuation (excluding follow-up phase) Based on visit dates
Query b3_cgic Integer Recommended Phase 3 Baseline CGIC
Query b3_resp Integer Recommended Phase 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:

  • 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

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