CDE Detailed Report
Disease: system
Subdomain Name: Drugs
CRF: files
Displaying 51 - 72 of 72
Subdomain Name: Drugs
CRF: files
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C54997 | Potency enhancing drug former use age end value | PotncyEnhancgDrugFmrUsAgEndVal | Age in years at which the subject/participant stopped taking the specified potency-enhancing drug | Age in years at which the subject/participant stopped taking the specified potency-enhancing drug | Age when use ended (years) | Numeric Values |
No instructions available |
No references available | Adult;Pediatric | Exploratory | 1.00 | 2017-04-13 14:32:36.0 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data |
Free-Form Entry |
Years | |||||||||
| C58990 | Medication hormone replacement past week other text | MedctnHrmneRplcmtPastWkOTH | The free-text field related to 'Medication hormone replacement past week type', specifying text | The free-text field related to 'Medication hormone replacement past week type', specifying text | Other, specify | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Supplemental | 1.00 | 2020-08-13 14:18:32.0 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C58969 | Medication cholesterol reduce control past week other text | MedctnCholRdcCtrlPastWkOTH | The free-text field related to 'Medication cholesterol reduce control past week type', specifying other text | The free-text field related to 'Medication cholesterol reduce control past week type', specifying other text | Other, specify | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Supplemental | 1.00 | 2020-07-30 16:45:06.0 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| 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 | |||||||||
| C58980 | Medication angiotensin receptor blocker past week type | MedctnAngtsnRcptrBlkrPastWkTyp | Type of angiotensin receptor blocker (ARB) medication taken by the subject/participant within the past week | Type of angiotensin receptor blocker (ARB) medication taken by the subject/participant within the past week | If angiotensin receptor blocker (ARB) history, indicate medication(s) the patient took within the past week | Candesartan;Losartan;Other, specify | Candesartan;Losartan;Other, specify | Alphanumeric |
Choose all that apply |
No references available | Adult;Pediatric | Supplemental | 1.00 | 2020-08-13 13:15:16.0 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
