CDE Detailed Report

Disease: content
Subdomain Name: Drugs
CRF: welcome

Displaying 51 - 72 of 72
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
C54987 Stimulant current former use duration SimulantCurFrmrUseDur Duration in months for which the subject/participant took or has taken the selected former or current stimulant Duration in months for which the subject/participant took or has taken the selected former or current stimulant Duration of Use (months) Numeric Values

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2017-04-13 14:32:36.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data

Free-Form Entry

Months
C58991 Medication hormone replacement therapy route type MedctnHrmneRplcmtTherpyRteTyp Type of administration route for the hormone replacement therapy medication taken by the subject/participant within the past week Type of administration route for the hormone replacement therapy medication taken by the subject/participant within the past week If YES, indicate the route of hormonal replacement therapy Oral;Topical;Transdermal;Other, specify;Unknown Oral;Topical;Transdermal;Other, specify;Unknown Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2020-08-13 14:20:24.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C54998 Medication immunosuppressant current former type MedctnImnosprsntCurrFrmrTyp Type of immunosuppressant medication formerly or currently taken by the subject/participant Type of immunosuppressant medication formerly or currently taken by the subject/participant Immunosuppressants Corticosteroids local;Corticosteroids systemic;Other, specify: Corticosteroids local;Corticosteroids systemic;Other, specify: Alphanumeric

Was the participant/ subject taking any of the following medications prior to admission or at the time of evaluation?

No references available Adult;Pediatric Exploratory 1.00 2017-04-13 13:56:57.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

C58970 PCSK9 inhibitor past three month indicator PCSK9InhibitorPastThreeMoInd The indicator related to whether the subject/participant was taking PCSK9 inhibitors (alirocumab, evolocumab) within the past three months The indicator related to whether the subject/participant was taking PCSK9 inhibitors (alirocumab, evolocumab) within the past three months If YES, was patient taking PCSK9 inhibitors within past three months (alirocumab, evolocumab) No;Yes;Unknown No;Yes;Unknown Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2020-07-30 16:45:46.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

C58981 Medication angiotensin receptor blocker past week other text MedctnAngtRtrBlkrPastWkOTH The free-text field related to 'Medication angiotensin receptor blocker past week type', specifying other text The free-text field related to 'Medication angiotensin receptor blocker past week type', specifying other text Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2020-08-13 13:23:35.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data 4000

Free-Form Entry

C54988 Stimulant current former use age start value StimulantCurFmrUsAgSttVal Age in years at which the subject/participant began taking the selected former or current stimulant Age in years at which the subject/participant began taking the selected former or current stimulant Age at Start (years) Numeric Values

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2017-04-13 14:32:36.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data

Free-Form Entry

Years
C58992 Medication hormone replacement therapy route other text MedctnHrmnRplcmThrpyRteOTH The free-text field related to 'Medication hormone replacement therapy route type', specifying text The free-text field related to 'Medication hormone replacement therapy route type', specifying text Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2020-08-13 14:31:46.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data 4000

Free-Form Entry

C54999 Medication immunosuppressant current former take other text MedctnImnosprsntCurrFrmrTkOTH The free-text field related to 'Medication immunosuppressant current former type' specifying other text The free-text field related to 'Medication immunosuppressant current former type' specifying other text Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Exploratory 1.00 2017-04-13 14:30:43.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data 4000

Free-Form Entry

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 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 2013-08-28 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 (please specify below) 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 instructions to record study medications.

No references available Adult;Pediatric Supplemental 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 Code 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 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 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

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 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 of the medication the participant/subject is taking.

No references available Adult;Pediatric Supplemental 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.

No references available Adult;Pediatric Supplemental 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.). Stop Date should be recorded if Continuing Medication is answered No. Conversely, Stop Date should remain blank if Continuing Medication is answered Yes.

No references available Adult;Pediatric Supplemental 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 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

Record how often the medication is being taken

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 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) Dose 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 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 Alphanumeric

Record the verbatim name (generic or trade name) of the medication the participant/subject reports taking. The following types of medications should definitely be queried and recorded: Antiplatelet; Anticoagulant history; Cholesterol-reducer history; Diabetic medication history; Antihypertensive history; Hormonal replacement history; Oral contraceptive history; and Implanted contraceptive history.

RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) Adult;Pediatric Supplemental 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.

No references available Adult;Pediatric Supplemental 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.

No references available Adult;Pediatric Supplemental 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 Dose 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

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 3.10 2022-08-02 14:36:00.0 Prior and Concomitant Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162730
CSV