CDE Detailed Report
Subdomain Name: Drugs
CRF: 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 | Alphanumeric |
If given for AE, enter exact term from AE CRF Record the reason the participant/subject gives for taking the medication. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | 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 within days prior study participation or during the study? | Yes;No | Yes;No | Alphanumeric |
If Yes, please complete below table for each concomitant medication. Including all prescription medications, vitamins, herbal supplements, and over the counter (OTCs). |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | 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 | 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 | 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 |
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 | 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. The code list displays the most common dose unit options. |
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ | Adult;Pediatric | Supplemental | 2.10 | 2022-08-02 14:27:44.0 | 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 per Administration | 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 | 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. The code list displays the most common options. |
No references available | Adult;Pediatric | Supplemental | 2.00 | 2022-08-02 16:52:05.0 | 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 day, month, and year the participant/subject stopped taking the medication. Stop Date should be recorded if Ongoing? is answered No. Conversely, Stop Date should remain blank if Ongoing? is answered Yes. This field should be completed to the best of the Investigator's knowledge. |
No references available | Adult;Pediatric | Supplemental | 3.10 | 2022-08-02 16:59:51.0 | 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. The code list displays the most common options. |
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 | 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 per Administration | 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 | 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 |
Verbatim name (generic or trade name) of the medication, including vitamins and herbal supplements the participant/subject reports taking.;Verbatim name (generic or trade name) of the rescue medication or treatment the participant/subject has received. |
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | 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. The code list displays the most common options. |
No references available | Adult;Pediatric | Supplemental | 3.10 | 2022-08-02 14:44:16.0 | 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.). |
No references available | Adult;Pediatric | Supplemental | 3.10 | 2022-08-02 16:58:56.0 | 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 of Dose | 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. The code list displays the most common dose unit options. |
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ | Adult;Pediatric | Supplemental | 3.10 | 2022-08-02 14:36:00.0 | Concomitant Medications | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
3162730 |
