CDE Detailed Report
Subdomain Name: Drugs
CRF: Prior and Current Treatments for MG - MG
Displaying 1 - 17 of 17
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C12689 | Myasthenia gravis treatment type | MGTrtmntTyp | Type of treatment used for myasthenia gravis (MG) | Type of treatment used for myasthenia gravis (MG) | Treatment Type | A;B;C;D;E;F;G | Acetylcholinesterase inhibitor;Corticosteroids;Immunosuppressant, specify;Immunomodulating agent, specify;IVIg;PLEX;Other, specify | Alphanumeric |
Record one treatment per row. For each treatment record the treatment type - choose one. If Immunosuppressant, Immunomodulating agent, or Other are answered for Treatment Type, specify agent used |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 21:00:23.88 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| 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 treatment or NO if the participant/subject has stopped taking the treatment. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
2321822 | |||||||
| C12691 | Medication prior or concomitant response text | MedctnPriorConcmtntRespnsTxt | Description of the response to the medication | Description of the response to the medication | Response? | Alphanumeric |
Record the response to each treatment. If no response, record none |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:36:20.083 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C02006 | Medication prior or concomitant dose | MedctnPriorOrConcomDose | Dose of prior/concomitant medication taken per administration | Dose of prior/concomitant medication taken per administration | Total (or average) Daily Dose | Numeric Values |
Record the strength of the medication the participant/subject is taking. |
No references available | Adult;Pediatric | Core | 3.10 | 2022-08-02 14:33:32.0 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data |
Free-Form Entry |
3162729 | |||||||||
| C17972 | Medication prior concomitant dose frequency Clinical Data Interchange Standards Consortium Standard Data Tabulation Model code | MedPriConDoseFreqCDISCSDTMCode | Code that represents the frequency of the dosage of the prior or concomitant medication administered. Clinical Data Interchange Standards Consortium Standard Data Tabulation Model (CDISC SDTM) | Code that represents the frequency of the dosage of the prior or concomitant medication administered. Clinical Data Interchange Standards Consortium Standard Data Tabulation Model (CDISC SDTM) | Dose Frequency | 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://evs.nci.nih.gov/ftp1/CDISC/SDTM/ | Adult;Pediatric | Supplemental | 3.00 | 2013-07-24 11:36:20.083 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| 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 | 3.10 | 2022-08-02 16:59:51.0 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data |
Free-Form Entry |
3162753 | |||||||||
| 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 (UCUM). |
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ | Adult;Pediatric | Core | 2.10 | 2022-08-02 14:27:44.0 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data | 4000 |
Free-Form Entry |
3162730 | ||||||||
| C02011 | Medication prior or concomitant dose frequency | MedctnPriorConcmtntDoseFreq | Frequency of use of a prior/concomitant medication | Frequency of use of a prior/concomitant medicatio | Dose 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. See the data dictionary for additional information on coding the frequency using CDISC SDTM Frequency Terminology. |
CDISC SDTM Frequency Terminology (Code C71113) - http://evs.nci.nih.gov/ftp1/CDISC/SDTM/ | Adult;Pediatric | Core | 3.00 | 2013-07-24 21:00:23.88 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
3162733 | |||||||
| C19533 | Immunomodulating agent other specify | ImmunomodAgentOth | The free-text field related to Immunomodulating agent, specify specifying other text | The free-text field related to Immunomodulating agent, specify specifying other tex | Immunomodulating agent, specify | Alphanumeric |
Record one treatment per row. For each treatment record the treatment type - choose one. If Immunosuppressant, Immunomodulating agent, or Other are answered for Treatment Type, specify agent used |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 21:00:23.88 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| 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 |
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 (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 Current Treatments for MG - MG | Drugs | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C19534 | Immunosuppressant specify | ImmunosuppressOth | The free-text field related to Immunosuppresant, specify specifying other text | The free-text field related to Immunosuppresant, specify specifying other tex | Immunosuppressant, specify | Alphanumeric |
Record one treatment per row. For each treatment record the treatment type - choose one. If Immunosuppressant, Immunomodulating agent, or Other are answered for Treatment Type, specify agent used |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 21:00:23.88 | Prior and Current Treatments for MG - MG | 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 | Treatment 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. |
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data | 4000 |
Free-Form Entry |
3162728 | ||||||||
| C19535 | Myasthenia gravis treatment other text | MGTrtmntOtherTxt | The free-text field related to Myasthenia gravis treatment type specifying other text | The free-text field related to Myasthenia gravis treatment type specifying other tex | Other, specify | Alphanumeric |
Record one treatment per row. For each treatment record the treatment type - choose one. If Immunosuppressant, Immunomodulating agent, or Other are answered for Treatment Type, specify agent used |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 21:00:23.88 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| 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 | Core | 3.10 | 2022-08-02 16:58:56.0 | Prior and Current Treatments for MG - MG | 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. See the data dictionary for additional information on coding the dosage unit of measure using Unified Code for Units of Measure (UCUM). |
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ | Adult;Pediatric | Core | 3.10 | 2022-08-02 14:36:00.0 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
3162730 | |||||||
| 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 | Treatment 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. |
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data | 255 |
Free-Form Entry |
3162728 | ||||||||
| C12641 | Medication side effect or complication indicator | MedctnSideEffctComplctnInd | Whether the participant/subject reports side effects or complications due to the medication | Whether the participant/subject reports side effects or complications due to the medication | Side effect or complication? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Record for each treatment |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 21:00:23.88 | Prior and Current Treatments for MG - MG | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
