CDE Detailed Report

Disease: Myasthenia Gravis
Sub-Domain: Drugs
CRF: Prior and Current Treatments for MG - MG

Displaying 1 - 17 of 17
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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
C02022 Medication prior or concomitant dose unit of measure MedctnPriorConcomDoseUo 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 3.00 2013-08-28 16:08:00.453 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 administered. 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

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

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 ongoing. 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

C02006 Medication prior or concomitant dose MedctnPriorConcomDose 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 3.00 2013-08-28 16:08:00.453 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

C02008 Medication prior or concomitant end date and time MedctnPriorConcomEndDateTime 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 3.00 2013-08-28 16:08:00.453 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 MedctnPriorConcomDoseUoMOTH 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 administered. 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 2.00 2018-03-13 16:27:22.0 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 medication. Dose Frequency BID;TID;QID;q2h;q4h;q6h;q8h;QAM;QPM;QD;AD;HS;PRN;OTH;UNK;NA twice daily;three times a day;four times a day;every 2 hours;every 4 hours;every 6 hours;every 8 hours;one dose in morning;one dose in evening;once daily;alternating day (every other day);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 text. 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

C02013 Medication prior or concomitant dose unit of measure UCUM code MedctnPriorConcomDoseUOMUCUMCd 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 3.00 2013-08-28 16:08:00.453 Prior and Current Treatments for MG - MG Drugs Treatment/Intervention Data 255

Free-Form Entry

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 text. 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

C02014 Medication prior or concomitant name MedctnPriorConcomName Name of the prior/concomitant agent or drug administered. Name of the prior/concomitant agent or drug administered. 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 text. 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

C02016 Medication prior or concomitant start date and time MedctnPriorConcomStrtDateTime 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 3.00 2013-08-28 16:08:00.453 Prior and Current Treatments for MG - MG Drugs Treatment/Intervention Data

Free-Form Entry

3162752
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