CDE Detailed Report

Disease: Traumatic Brain Injury
Sub-Domain: 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 / 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
C02006 Medication prior or concomitant dose MedctnPriorOrConcomDose Dose of prior/concomitant medication taken per administration Dose of prior/concomitant medication taken per administration Dosage of prior/concomitant medication taken per administration Numeric Values

Record the strength of the medication the participant/subject is taking. The code list displays the most popular dose unit options.

RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) 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 Alphanumeric

Choose one route of administration. The code list displays the most popular options.

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. Medication prior or concomitant end date and time 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 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 of prior/concomitant medication use 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. The code list displays the most popular options.

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 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) Code that represents dosage unit of measurement Alphanumeric

Code the units of the medication the participant/subject is taking using Unified Code for Units of Measure (UCUM).

Unified Code for Units of Measure (UCUM) for the codes for the units of measure: 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 Name of the prior/concomitant agent or drug administered Alphanumeric

Verbatim name (generic or trade name) of the medication the participant/subject reports taking. Add date stamp for when assessed. Recommend collection at least on date of TBI.

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 Type of access route for administration of prior/concomitant medication 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

Choose one route of administration. The code list displays the most popular options.

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. Medication prior or concomitant start date and time 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 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 Dosage unit of measurement 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
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 Reason for administration of prior/concomitant agent or measure Alphanumeric

Response is obtained from report by participant/subject. If given for an AE, enter exact term from AE 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 Indicates reported medication use during the time period relevant to the study protocol 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. Add date stamp for when assessed. Recommend collection at least on date of TBI. 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 for the name of prior/concomitant agent or drug administered Alphanumeric

Code for the medication the participant/subject reports taking. Add date stamp for when assessed. Recommend collection at least on date of TBI.

RXNorm for the medication codes (http://www.nlm.nih.gov/research/umls/rxnorm/; use the atom unique identifier or RXAUI code) 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 Indicates or describes that prior/concomitant medication usage is ongoing Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one.

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 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
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