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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: Global Outcome
CRF: MG Status - MG
Item count: 12 (12 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
C06005
Data collected date and time
DataCollDateTime
Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed.
Date of Visit
  
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
7/24/2013
Aliases for variable name not defined
MG Status - MG
Global Outcome
Outcomes and End Points
Data collected date and time
 
Free-Form Entry
       
C12652
Myasthenia Gravis Foundation of America (MGFA) - post-intervention status
MFGAPostIntrvntnStatus
The Myasthenia Gravis Foundation of America (MGFA) post intervention status
MGFA Post Intervention Status
CSR;PR;MM-0;MM-1;MM-2;MM-3;Improved;Unchanged;Worse;Exacerbation;Died of MG;
Complete Stable Remission (CSR) – The patient has no symptoms or signs of MG for at least 1 year and has received no therapy for MG during that time. There is no weakness of any muscle on careful examination by someone skilled in the evaluation of neuromuscular disease. Isolated weakness of eye closure is accepted.;Pharmacologic Remissions (PR) – The same criteria as for CSR except that the patient continues to take some form of therapy for MG. Patients taking cholinesterase inhibitors are excluded from this category because their use suggests the presence of weakness.;Minimal Manifestation (MM) – The patient has no symptoms or functional limitations from MG but has some weakness on examination of some muscles. This class recognizes that some patients who otherwise meet the definition of CSR or PR do have weakness that is only detectable by careful examination. MM-0: The patient has received no MG treatment for at least [1 year]. The duration of post-intervention status of outcome is left to the discretion of the Investigator, but should be predetermined.;Minimal Manifestation (MM) – The patient has no symptoms or functional limitations from MG but has some weakness on examination of some muscles. This class recognizes that some patients who otherwise meet the definition of CSR or PR do have weakness that is only detectable by careful examination. MM-1: The patient continues to receive some form of immunosuppression but no cholinesterase inhibitors or other symptomatic therapy.;Minimal Manifestation (MM) – The patient has no symptoms or functional limitations from MG but has some weakness on examination of some muscles. This class recognizes that some patients who otherwise meet the definition of CSR or PR do have weakness that is only detectable by careful examination. MM-2: The patient has received only low dose cholinesterase inhibitors (< 120 mg pyridostigmine per day), for at least [1 year]. The duration of post-intervention status of outcome is left to the discretion of the Investigator, but should be predetermined.;Minimal Manifestation (MM) – The patient has no symptoms or functional limitations from MG but has some weakness on examination of some muscles. This class recognizes that some patients who otherwise meet the definition of CSR or PR do have weakness that is only detectable by careful examination. MM-3: Patient has received cholinesterase inhibitors or other symptomatic therapy and some form of immunosuppression during the past year.;Improved (I) – A substantial decrease in pre-treatment clinical manifestations or a sustained substantial reductions in MG medications as defined in the protocol. In prospective studies, this should be defined as a specific decrease in a predetermined quantitative score, if the patient has not met minimal manifestations or better.;Unchanged (U) – No substantial change in pre-treatment clinical manifestations or reduction in MG medications as defined in the protocol. In prospective studies, this should be defined in terms of a maximum change in a predetermined quantitative score, if the patient has not met minimal manifestations or better.;Worse (W) – A substantial increase in pre-treatment clinical manifestations or a substantial increase in MG medications as defined in the protocol. In prospective studies, this should be defined as a specific increase in a predetermined quantitative score.;Exacerbation (E) – Patients who have fulfilled criteria for CSR, PR, or MM but subsequently developed clinical findings greater than permitted by these criteria. In prospective studies, this should be defined in terms of a change in a predetermined quantitative score.;Died of MG (D of MG) – Patients who died of MG, of complications of MG therapy, or within 30 days after thymectomy. List the cause.;
Alphanumeric
Complete Stable Remission (CSR) – The patient has no symptoms or signs of MG for at least 1 year and has received no therapy for MG during that time. There is no weakness of any muscle on careful examination by someone skilled in the evaluation of neuromuscular disease. Isolated weakness of eye closure is accepted.;Pharmacologic Remissions (PR) – The same criteria as for CSR except that the patient continues to take some form of therapy for MG. Patients taking cholinesterase inhibitors are excluded from this category because their use suggests the presence of weakness.;Minimal Manifestation (MM) – The patient has no symptoms or functional limitations from MG but has some weakness on examination of some muscles. This class recognizes that some patients who otherwise meet the definition of CSR or PR do have weakness that is only detectable by careful examination. MM-0: The patient has received no MG treatment for at least [1 year]. The duration of post-intervention status of outcome is left to the discretion of the Investigator, but should be predetermined.;Minimal Manifestation (MM) – The patient has no symptoms or functional limitations from MG but has some weakness on examination of some muscles. This class recognizes that some patients who otherwise meet the definition of CSR or PR do have weakness that is only detectable by careful examination. MM-1: The patient continues to receive some form of immunosuppression but no cholinesterase inhibitors or other symptomatic therapy.;Minimal Manifestation (MM) – The patient has no symptoms or functional limitations from MG but has some weakness on examination of some muscles. This class recognizes that some patients who otherwise meet the definition of CSR or PR do have weakness that is only detectable by careful examination. MM-2: The patient has received only low dose cholinesterase inhibitors (< 120 mg pyridostigmine per day), for at least [1 year]. The duration of post-intervention status of outcome is left to the discretion of the Investigator, but should be predetermined. ;Minimal Manifestation (MM) – The patient has no symptoms or functional limitations from MG but has some weakness on examination of some muscles. This class recognizes that some patients who otherwise meet the definition of CSR or PR do have weakness that is only detectable by careful examination. MM-3: Patient has received cholinesterase inhibitors or other symptomatic therapy and some form of immunosuppression during the past year.;Improved (I) – A substantial decrease in pre-treatment clinical manifestations or a sustained substantial reductions in MG medications as defined in the protocol. In prospective studies, this should be defined as a specific decrease in a predetermined quantitative score, if the patient has not met minimal manifestations or better.;Unchanged (U) – No substantial change in pre-treatment clinical manifestations or reduction in MG medications as defined in the protocol. In prospective studies, this should be defined in terms of a maximum change in a predetermined quantitative score, if the patient has not met minimal manifestations or better. ;Worse (W) – A substantial increase in pre-treatment clinical manifestations or a substantial increase in MG medications as defined in the protocol. In prospective studies, this should be defined as a specific increase in a predetermined quantitative score.;Exacerbation (E) – Patients who have fulfilled criteria for CSR, PR, or MM but subsequently developed clinical findings greater than permitted by these criteria. In prospective studies, this should be defined in terms of a change in a predetermined quantitative score.;Died of MG (D of MG) – Patients who died of MG, of complications of MG therapy, or within 30 days after thymectomy. List the cause.
No references available
Adult;Pediatric
Core
3.0
7/24/2013
Aliases for variable name not defined
MG Status - MG
Global Outcome
Outcomes and End Points
MGFA post intervention status
 
Single Pre-Defined Value Selected
       
C12644
Institute of Neurology Carlo Besta (INNCB) Myasthenia Gravis scale - total score
INNCBMGScaleTotalScore
Participant/Subject's total score for the Fondazione Istituto Neurologico “Carlo Besta” (INNCB) Myasthenia Gravis Scale
Total Score
  
Numeric Values
Taken at each study visit
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
MG Status - MG
Global Outcome
Outcomes and End Points
INNCB MG scale total score
 
Free-Form Entry
       
C12645
Institute of Neurology Carlo Besta (INNCB) Myasthenia Gravis scale - muscle fatigue score
INNCBMGScalMuScaleFatigScore
Participant/Subject's Muscle fatigability score for the Fondazione Istituto Neurologico “Carlo Besta” (INNCB) Myasthenia Gravis Scale
Muscle Fatigability
  
Numeric Values
Taken at each study visit
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
MG Status - MG
Global Outcome
Outcomes and End Points
INNCB MG scale muscle fatigability score
 
Free-Form Entry
       
C12646
Quantitative Myasthenia Gravis (QMG) - score
QMGScore
Participant/Subject's Quantitative Myasthenia Gravis (QMG) score (0-39)
QMG Score
  
Numeric Values
Taken at each study visit
Jaretzki A, III, Barohn RB, Ernstoff RM, Kaminski HJ, Keesey JC, Penn AS, et al. Myasthenia gravis: recommendations for clinical research standards. Neurology 2000; vol 55:16-23. Wolfe GI, Herbelin LL, Nations SP, et al. Myasthenia gravis activity of daily living profile. Neurology 1999; 52:1487-1489.
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
MG Status - MG
Global Outcome
Outcomes and End Points
QMG score
 
Free-Form Entry
0
39
     
C12647
Myasthenia gravis muscle manual testing (MG-MMT) - score
MGMMTScore
Participant/subject's score on the Myasthenia gravis muscle manual testing (MG-MMT)
MG-MMT Score
  
Numeric Values
Taken at each study visit
Sanders DB, Tucker-Lipscomb B, Massey JM. A simple manual muscle test for myasthenia gravis: validation and comparison with the QMG score. Ann N Y Acad Sci. 2003 Sep;998:440-4.
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
MG Status - MG
Global Outcome
Outcomes and End Points
MG-MMT score
 
Free-Form Entry
       
C12648
Myasthenia gravis composite score
MGCompositeScore
Participant/Subject's Myasthenia Gravis (MG) Composite score (0-50)
MG Composite
  
Numeric Values
Taken at each study visit
Burns TM, Conaway M, Sanders DB; MG Composite and MG-QOL15 Study Group. The MG Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology. 2010 May 4;74(18):1434-40.
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
MG Status - MG
Global Outcome
Outcomes and End Points
MG composite score
 
Free-Form Entry
0
50
     
C12649
Myasthenia Gravis Activities of Daily Living (MG-ADL) - score
MGADLScore
Participant/Subject's Myasthenia Gravis Activities of Daily Living (MG-ADL) score (0-24)
MG-ADL Score
  
Numeric Values
Taken at each study visit
Muppidi S, Wolfe GI, Conaway M, Burns TM; MG-ADL: still a relevant outcome measure.; Muscle Nerve; 2011 Nov; 44(5); 727-731
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
MG Status - MG
Global Outcome
Outcomes and End Points
MG-ADL score
 
Free-Form Entry
0
24
     
C12653
Myasthenia Gravis Quality-of-Life Scale (MG-QOL15) - score
MGQOL15Score
The participant/subject's 15-item Myasthenia Gravis Quality-of-Life Scale (MG-QOL15) score
MG-QOL 15 Score
  
Numeric Values
Taken at each study visit
Muscle and Nerve 2008;38:957-963. Muscle and Nerve;2010;41:219-226. Muscle and Nerve;2011;43:14-18
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
MG Status - MG
Global Outcome
Outcomes and End Points
MG-QOL 15 score
 
Free-Form Entry
       
C12654
Global impression change patient score
GloblImprssnChngPatntScore
The patient reported global impression of change score
Global Impression of Change, Patient
  
Numeric Values
No additional instructions
Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville, MD, U.S. Department of Health, Education, and Welfare
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
MG Status - MG
Global Outcome
Outcomes and End Points
Global impression of change patient score
 
Free-Form Entry
       
C12655
Global impression change physician score
GloblImprssnChngPhyscnScore
The physician reported global impression of change score
Global Impression of Change, Physician
  
Numeric Values
No additional instructions
Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville, MD, U.S. Department of Health, Education, and Welfare
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
MG Status - MG
Global Outcome
Outcomes and End Points
Global impression of change physician score
 
Free-Form Entry
       
C17981
Other measure severity text
OthrMeasrSevrtyTxt
The text describing the specifics of the other measures of severity to test MG
Other measures of severity specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
MG Status - MG
Global Outcome
Outcomes and End Points
 
255
Free-Form Entry
       
07-15-2019
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