CDE Detailed Report | NINDS Common Data Elements

Disease: Duchenne Muscular Dystrophy/Becker Muscular Dystrophy
Subdomain Name: Drugs
CRF: Prior and Current Medications

Displaying 1 - 19 of 19

CDE ID	CDE Name	Variable Name	Definition	Short Description	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 / Guidance)	Subdomain Name	Domain Name	Size	Input Restrictions	External Id caDSR
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 administere	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	MedctnPriorOrConcmStrtDateTime	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	3.10	2022-08-02 16:58:56.0	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	MedctnPriorOrConcomDoseUOM	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	3.10	2022-08-02 14:36:00.0	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 administere	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	MedctnPriorOrConcomDoseUoMOTH	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 administere	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	2.10	2022-08-02 14:27:44.0	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
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 ongoin	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	MedctnPriorOrConcomEndDateTime	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	3.10	2022-08-02 16:59:51.0	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 medicatio	Dose Frequency	BID;TID;QID;q2h;q4h;q6h;q8h;QAM;QPM;QD;alt. d.;HS;PRN;OTH;UNK;NA	twice a day;three times a day;four times a day;every 2 hours;every 4 hours;every 6 hours;every 8 hours;every morning;every evening;one a day;every other day (on alternate days);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	MedctnPriorOrConDseUOMUCUMCode	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	3.10	2022-08-02 14:42:09.0	Prior and Current Medications	Drugs	Treatment/Intervention Data	255	Free-Form Entry