CDE Detailed Report

Disease: Facioscapulohumeral Muscular Dystrophy
Subdomain Name: Drugs
CRF: Prior and Concomitant Medications

Displaying 1 - 14 of 14
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 Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C02024 Medication prior or concomitant indication text MedctnPriorConcomIndTxt Text describing reason for administration of a prior/concomitant (nonstudy) agent or measure. This is not the pharmacologic classification of an agent (antibiotic, analgesic, etc.), but the reason for its administration to the participant/subject Text describing reason for administration of a prior/concomitant (nonstudy) agent or measure. This is not the pharmacologic classification of an agent (antibiotic, analgesic, etc.), but the reason for its administration to the participant/subjec Indication (If given for AE, enter exact term from AE CRF) Alphanumeric

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

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-08-28 16:08:00.453 Prior and Concomitant Medications Drugs Treatment/Intervention Data 4000

Free-Form Entry

3158920
C02002 Medication prior or concomitant use indicator MedctnPriorConcomUseInd Indicator of whether the participant/subject reported taking any medications during the time period relevant to the study protocol Indicator of whether the participant/subject reported taking any medications during the time period relevant to the study protocol Did the participant/subject take any medications__days before or during the study? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. If this question is answered YES then at least one prior/concomitant 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 no, leave rest of form blank.

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-22 16:57:17.79 Prior and Concomitant Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

2220500
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 Medication Name (Trade of generic name) Alphanumeric

Code the verbatim name (generic or trade name) of the medication using RXNorm.

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

Free-Form Entry

3162728
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 medication or NO if the participant/subject has stopped taking the medication.

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

Single Pre-Defined Value Selected

2321822
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

No references available Adult;Pediatric Supplemental-Highly Recommended 2.10 2022-08-02 14:27:44.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162730
C02006 Medication prior or concomitant dose MedctnPriorOrConcomDose Dose of prior/concomitant medication taken per administration Dose of prior/concomitant medication taken per administration Dose Numeric Values

Record the strength and the units of the medication the participant/subject is taking.

No references available Adult;Pediatric Supplemental-Highly Recommended 3.10 2022-08-02 14:33:32.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data

Free-Form Entry

3162729
C18737 Medication prior or concomitant route type other text MedctnPriorOrConcomRteTypOTH The free-text field related to 'Medication prior or concomitant route type', specifying other text. Type of access route for the administration of the prior/concomitant medication The free-text field related to 'Medication prior or concomitant route type', specifying other text. Type of access route for the administration of the prior/concomitant medication Other, specify Alphanumeric

Record the route of administration. Acceptable responses for Route are shown below the medication table

No references available Adult;Pediatric Supplemental-Highly Recommended 2.00 2022-08-02 16:52:05.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162743
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

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). 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.).

No references available Adult;Pediatric Supplemental-Highly Recommended 3.10 2022-08-02 16:59:51.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data

Free-Form Entry

3162753
C02011 Medication prior or concomitant dose frequency MedctnPriorConcmtntDoseFreq Frequency of use of a prior/concomitant medication Frequency of use of a prior/concomitant medicatio Freq 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

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://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/cdisc) - http://evs.nci.nih.gov/ftp1/CDISC/SDTM/ Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-24 21:00:23.88 Prior and Concomitant Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162733
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) Units Alphanumeric

Code the unit of measure of the medication dosage using Unified Code for Units of Measure (UCUM).

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental-Highly Recommended 3.10 2022-08-02 14:42:09.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data 255

Free-Form Entry

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 Medication Name (Trade of generic 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

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-08-28 16:08:00.453 Prior and Concomitant Medications Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162728
C02015 Medication prior or concomitant route type MedctnPriorOrConcomRteTyp Type of access route for the administration of the prior/concomitant medication Type of access route for the administration of the prior/concomitant medication Route Buccal;Inhaled;Intramuscular;Intravenous;Nasal;Oral;Rectal;By ear;Topical;Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify Buccal;Inhaled;Intramuscular;Intravenous;Nasal;Oral;Rectal;By Ear;Topical;Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify Alphanumeric

Record the route of administration. Acceptable responses for Route are shown below the medication table

No references available Adult;Pediatric Supplemental-Highly Recommended 3.10 2022-08-02 14:44:16.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162743
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

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). 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.). 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 Concomitant Medications Drugs Treatment/Intervention Data

Free-Form Entry

3162752
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 Units g;mcg;mcL;mg;mL;oz;Other, specify;Unknown;NA gram;microgram;microliter;milligram;milliliter;ounce;Other, specify;Unknown;Not applicable 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

No references available Adult;Pediatric Supplemental-Highly Recommended 3.10 2022-08-02 14:36:00.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162730
CSV