CDE Detailed Report

Disease: Duchenne Muscular Dystrophy/Becker Muscular Dystrophy
Sub-Domain: Drugs
CRF: Prior and Current Medications

Displaying 1 - 19 of 19
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C18290 Steroid treatment start age value StrdTreatmtStartAgeVal Age when the steroid treatments began Age when the steroid treatments began Age (to the nearest 1/2 year) Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Prior and Current Medications Drugs Treatment/Intervention Data

Free-Form Entry

C02003 Medication prior or concomitant ongoing indicator MedctPrConcomOngoingInd Indicator of or description that the prior/concomitant medication usage is ongoing. Indicator of or description that the prior/concomitant medication usage is ongoing. Ongoing? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. Answer YES if the participant/subject is still taking the treatment or NO if the participant/subject has stopped taking the treatment.

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Prior and Current Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

2321822
C18291 Steroid treatment stop age value StrdTreatmtStopAgeVal Age when the steroid treatments ended Age when the steroid treatments ended Age (to the nearest 1/2 year) Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Prior and Current Medications Drugs Treatment/Intervention Data

Free-Form Entry

C02008 Medication prior or concomitant end date and time MedctnPriorConcomEndDateTime The date (and time, if applicable and known) the administration of the prior/concomitant medication ended. The date (and time, if applicable and known) the administration of the prior/concomitant medication ended. End Date Date or Date & Time

Supplemental - Highly Recommended
Record the date (and time if applicable to the study) the participant/subject stopped taking the medication. The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database. End Date should be recorded if Continuing Medication is answered NO. Conversely, End Date should remain blank if Continuing Medication is answered YES. Studies that need to collect End Time will need to add fields for time to the form template.

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-08-28 16:08:00.453 Prior and Current Medications Drugs Treatment/Intervention Data

Free-Form Entry

3162753
C18294 Steroid treatment dose StrdTreatmtDose Dose of the steroid treatment that the participant/subject is taking per administration Dose of the steroid treatment that the participant/subject is taking per administration Dose Numeric Values

Record the strength and units of the medication the participant/subject is taking
Supplemental - Highly Recommended

No references available Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Prior and Current Medications Drugs Treatment/Intervention Data

Free-Form Entry

C02011 Medication prior or concomitant dose frequency MedctnPriorConcmtntDoseFreq Frequency of use of a prior/concomitant medication. Frequency of use of a prior/concomitant medication. Dose Frequency BID;TID;QID;q2h;q4h;q6h;q8h;QAM;QPM;QD;AD;HS;PRN;OTH;UNK;NA twice daily;three times a day;four times a day;every 2 hours;every 4 hours;every 6 hours;every 8 hours;one dose in morning;one dose in evening;once daily;alternating day (every other day);at bedtime;as needed;Other, specify;unknown;Not applicable Alphanumeric

Supplemental - Highly Recommended
Record how often the medication is being taken. See the data dictionary for additional information on coding the frequency using CDISC SDTM Frequency Terminology.

CDISC SDTM Frequency Terminology (Code C71113) - http://evs.nci.nih.gov/ftp1/CDISC/SDTM/ Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Prior and Current Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162733
C18300 Medication supplement use indicator MedctnSupplUseInd Indicator of whether the participant/subject has ever taken physician prescribed medications, investigational medications or supplements Indicator of whether the participant/subject has ever taken physician prescribed medications, investigational medications or supplements Has the participant/ subject ever taken physician prescribed medications, investigational medications, or supplements? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. If this question is answered YES then at least one prior/current medication record needs to be recorded. Do NOT record study medications taken (if study has a drug intervention) on this form. Refer to the Study Drug Dosing form to record study medications.If Yes, complete Table #2 - add additional lines as needed. Use a separate line when the dose or frequency of a treatment has changed. If No, stop completing the form

No references available Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Prior and Current Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

C02013 Medication prior or concomitant dose unit of measure UCUM code MedctnPriorConcomDoseUOMUCUMCd Code that represents the dosage unit of measure of the prior or concomitant medication administered. Unified Code for Units of Measure (UCUM). Code that represents the dosage unit of measure of the prior or concomitant medication administered. Unified Code for Units of Measure (UCUM). Dose Units Alphanumeric

Record the units of the medication the participant/subject is taking. See the data dictionary for additional information on coding the dosage unit of measure using Unified Code for Units of Measure (UCUM).

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Prior and Current Medications Drugs Treatment/Intervention Data 255

Free-Form Entry

C18301 Steroid treatment Duchenne or Becker Muscular Dystrophy indicator StrdTreatmntDMDBMDInd Indicator for whether the participant/subject has ever taken steroids for the treatment of Duchenne (DMD) or Becker (BMD) Muscular Dystrophy Indicator for whether the participant/subject has ever taken steroids for the treatment of Duchenne (DMD) or Becker (BMD) Muscular Dystrophy Has the participant/subject ever taken steroids for the treatment of the Duchenne or Becker Muscular Dystrophy? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Yes (Complete Table #1 - add additional lines as needed. Use a separate line when the dose or frequency of a treatment has changed.). No (Do not complete Table #1, Skip to Question #2)

No references available Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Prior and Current Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

C02014 Medication prior or concomitant name MedctnPriorConcomName Name of the prior/concomitant agent or drug administered. Name of the prior/concomitant agent or drug administered. Treatment Name Alphanumeric

Record the verbatim name (generic or trade name) of the medication the participant/subject reports taking. See the data dictionary for additional information on coding the medication name using RXNorm.

RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Prior and Current Medications Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162728
C18302 Medication supplement indication text MedctnSupplementIndTxt Text describing the indication or reason the participant/subject is taking the medication or supplement Text describing the indication or reason the participant/subject is taking the medication or supplement Indication Alphanumeric

Record the reason the participant/subject gives for taking the medication. If given for an AE, enter exact term from Adverse Event CRF.

No references available Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Prior and Current Medications Drugs Treatment/Intervention Data 255

Free-Form Entry

C02016 Medication prior or concomitant start date and time MedctnPriorConcomStrtDateTime The date (and time, if applicable and known) on which the prior/concomitant medication usage began. The date (and time, if applicable and known) on which the prior/concomitant medication usage began. Start Date Date or Date & Time

Supplemental - Highly Recommended
Record the date (and time if applicable to the study) the participant/subject started taking the medication. The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database. Start Date can be used to distinguish between prior medications and concomitant medications. Studies that need to collect Start Time will need to add fields for time to the form template.

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-08-28 16:08:00.453 Prior and Current Medications Drugs Treatment/Intervention Data

Free-Form Entry

3162752
C18307 Steroid treatment stop change reason StrdTreatmtStopChngRsn Reason the steroid treatment was stopped or changed Reason the steroid treatment was stopped or changed Reason(s) Stopped/Changed Hypertension;Excessive Weight Gain;Adjustment for growth;Loss of ambulation;Fractures;Behavior Disorder;Growth Failure;Delayed Puberty Hypertension;Excessive Weight Gain;Adjustment for growth;Loss of ambulation;Fractures;Behavior Disorder;Growth Failure;Delayed Puberty Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Prior and Current Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

C02022 Medication prior or concomitant dose unit of measure MedctnPriorConcomDoseUo Dosage unit of measure of the prior or concomitant medication administered. Dosage unit of measure of the prior or concomitant medication administered. Dose Units g;mcg;mcL;mg;mL;oz;Other, specify;Unknown;NA gram;microgram;microliter;milligram;milliliter;ounce;Other, specify;Unknown;Not applicable Alphanumeric

Supplemental - Highly Recommended
Record the units of the medication the participant/subject is taking. See the data dictionary for additional information on coding the dosage unit of measure using Unified Code for Units of Measure (UCUM).

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Prior and Current Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162730
C18364 Medication supplement name MedctnSupplName Name of the medication or supplement administered Name of the medication or supplement administered Medication/Supplement Name Alphanumeric RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Prior and Current Medications Drugs Treatment/Intervention Data 255

Free-Form Entry

3162728
C02025 Medication prior or concomitant RXNorm code MedctnPriorConcomRxNormCode Code for name of the prior/concomitant agent or drug administered. Code for name of the prior/concomitant agent or drug administered. Treatment Name Alphanumeric

Record the verbatim name (generic or trade name) of the medication the participant/subject reports taking. See the data dictionary for additional information on coding the medication name using RXNorm.

RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Prior and Current Medications Drugs Treatment/Intervention Data 255

Free-Form Entry

3162728
C18736 Medication prior or concomitant dose unit of measure other text MedctnPriorConcomDoseUoMOTH The free-text field related to 'Medication prior or concomitant dose unit of measure' specifying other text. Dosage unit of measure of the prior or concomitant medication administered. The free-text field related to 'Medication prior or concomitant dose unit of measure' specifying other text. Dosage unit of measure of the prior or concomitant medication administered. Other, specify Alphanumeric

Record the units of the medication the participant/subject is taking. See the data dictionary for additional information on coding the dosage unit of measure using Unified Code for Units of Measure (UCUM).

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 2.00 2018-03-13 16:27:22.0 Prior and Current Medications Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162730
C12691 Medication prior or concomitant response text MedctnPriorConcmtntRespnsTxt Description of the response to the medication Description of the response to the medication Response? Alphanumeric

Record the response to each treatment. If no response, record none

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:36:20.083 Prior and Current Medications Drugs Treatment/Intervention Data 255

Free-Form Entry

C17972 Medication prior concomitant dose frequency Clinical Data Interchange Standards Consortium Standard Data Tabulation Model code MedPriConDoseFreqCDISCSDTMCode Code that represents the frequency of the dosage of the prior or concomitant medication administered. Clinical Data Interchange Standards Consortium Standard Data Tabulation Model (CDISC SDTM) Code that represents the frequency of the dosage of the prior or concomitant medication administered. Clinical Data Interchange Standards Consortium Standard Data Tabulation Model (CDISC SDTM) Dose Frequency Alphanumeric

Record how often the medication is being taken. See the data dictionary for additional information on coding the frequency using CDISC SDTM Frequency Terminology.

CDISC SDTM Frequency Terminology (Code C71113) - http://evs.nci.nih.gov/ftp1/CDISC/SDTM/ Adult;Pediatric Supplemental 3.00 2013-07-24 11:36:20.083 Prior and Current Medications Drugs Treatment/Intervention Data 255

Free-Form Entry

CSV