CDE Detailed Report

Disease: Myasthenia Gravis
Sub-Domain: Global Outcome
CRF: MG Status - MG

Displaying 1 - 12 of 12
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
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) 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 3.00 2013-07-24 21:00:23.88 MG Status - MG Global Outcome Outcomes and End Points

Free-Form Entry

0 24
C12652 Myasthenia Gravis Foundation of America (MGFA) - post-intervention status MFGAPostIntrvntnStatus The Myasthenia Gravis Foundation of America (MGFA) post intervention status 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 (

No references available Adult;Pediatric Core 3.00 2013-07-24 21:00:23.88 MG Status - MG Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

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 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 3.00 2013-07-24 21:00:23.88 MG Status - MG Global Outcome Outcomes and End Points

Free-Form Entry

C12654 Global impression change patient score GloblImprssnChngPatntScore The patient reported global impression of change score 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 3.00 2013-07-24 21:00:23.88 MG Status - MG Global Outcome Outcomes and End Points

Free-Form Entry

C12655 Global impression change physician score GloblImprssnChngPhyscnScore The physician reported global impression of change score 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 3.00 2013-07-24 21:00:23.88 MG Status - MG Global Outcome Outcomes and End Points

Free-Form Entry

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 (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 3.00 2013-07-24 21:00:23.88 MG Status - MG Global Outcome Outcomes and End Points

Free-Form Entry

C17981 Other measure severity text OthrMeasrSevrtyTxt The text describing the specifics of the other measures of severity to test MG The text describing the specifics of the other measures of severity to test MG Other measures of severity specify Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 MG Status - MG Global Outcome Outcomes and End Points 255

Free-Form Entry

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 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 3.00 2013-07-24 21:00:23.88 MG Status - MG Global Outcome Outcomes and End Points

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 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 3.00 2013-07-24 21:00:23.88 MG Status - MG Global Outcome Outcomes and End Points

Free-Form Entry

C12646 Quantitative Myasthenia Gravis (QMG) - score QMGScore Participant/Subject's Quantitative Myasthenia Gravis (QMG) score (0-39) 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 3.00 2013-07-24 21:00:23.88 MG Status - MG Global Outcome Outcomes and End Points

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) 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 3.00 2013-07-24 21:00:23.88 MG Status - MG Global Outcome Outcomes and End Points

Free-Form Entry

C12648 Myasthenia gravis composite score MGCompositeScore Participant/Subject's Myasthenia Gravis (MG) Composite score (0-50) 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 3.00 2013-07-24 21:00:23.88 MG Status - MG Global Outcome Outcomes and End Points

Free-Form Entry

0 50
CSV