of0
Export
 
CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease:
Sub-Domain: Drugs
CRF: Prior and Current Treatments for MG - MG
Item count: 17 (17 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C19535
Myasthenia gravis treatment other text
MGTrtmntOtherTxt
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
3.0
7/24/2013
Aliases for variable name not defined
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.
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
3.0
7/24/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
 
255
Free-Form Entry
       
C19533
Immunomodulating agent other specify
ImmunomodAgentOth
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
3.0
7/24/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
 
255
Free-Form Entry
       
C12689
Myasthenia gravis treatment type
MGTrtmntTyp
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
3.0
7/24/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
MG treatment type
 
Single Pre-Defined Value Selected
       
C02014
Medication prior or concomitant name
MedctnPriorConcomName
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
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
Medication prior or concomitant name
4000
Free-Form Entry
     
3162728
 
C02025
Medication prior or concomitant RXNorm code
MedctnPriorConcomRxNormCode
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
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
Medication prior or concomitant RXNorm code
255
Free-Form Entry
     
3162728
 
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)
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
3.0
7/24/2013
Aliases for variable name not defined
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.
Total (or average) Daily Dose
  
Numeric Values
Record the strength of the medication the participant/subject is taking.
No references available
Adult;Pediatric
Core
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose
 
Free-Form Entry
     
3162729
 
C02022
Medication prior or concomitant dose unit of measure
MedctnPriorConcomDoseUo
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
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose unit of measure
 
Single Pre-Defined Value Selected
     
3162730
 
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.
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
2.0
3/13/2018
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
     
3162730
 
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).
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
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose unit of measure UCUM code
255
Free-Form Entry
       
C02011
Medication prior or concomitant dose frequency
MedctnPriorConcmtntDoseFreq
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
3.0
7/24/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose frequency
 
Single Pre-Defined Value Selected
     
3162733
 
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.
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
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
Medication prior or concomitant start date and time
 
Free-Form Entry
     
3162752
 
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.
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
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
Medication prior or concomitant end date and time
 
Free-Form Entry
     
3162753
 
C02003
Medication prior or concomitant ongoing indicator
MedctPrConcomOngoingInd
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
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
Medication prior or concomitant ongoing indicator
 
Single Pre-Defined Value Selected
     
2321822
 
C12641
Medication side effect or complication indicator
MedctnSideEffctComplctnInd
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
3.0
7/24/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
Medication prior or concomitant side effect or complication indicator
 
Single Pre-Defined Value Selected
       
C12691
Medication prior or concomitant response text
MedctnPriorConcmtntRespnsTxt
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
3.0
7/24/2013
Aliases for variable name not defined
Prior and Current Treatments for MG - MG
Drugs
Treatment/Intervention Data
Medication prior or concomitant response text
255
Free-Form Entry
       
07-15-2019
Page 1 of 1