CDE Detailed Report

Disease: content
Subdomain Name: History of Disease/Injury Event
CRF: welcome

Displaying 1 - 14 of 14
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
C12650 Osserman classification type OssermanClassTyp Osserman classification of Myasthenia Gravis Osserman classification of myasthenia gravis Osserman classification I;IIA;IIB;drug response less than satisfactory;III;IV Ocular myasthenia;Mild generalized myasthenia with slow progression: no crises, responsive to drugs;Moderately severe generalized myasthenia : severe skeletal and bulbar involvement but no crises;;Acute fulminating myasthenia, rapid progression of severe symptoms, with respiratory crises and poor drug response;Late severe myasthenia, same as III but progression over 2 years from class I to II Alphanumeric

Taken at the maximum severity of Myasthenia Gravis symptoms

Ossermann KE. Myasthenia gravis. New York: Grune and Stratton; 1958. Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C08006 Symptoms first appear date and time SymptmFirstAppearDateTime Date (and time if applicable and known) the symptoms for the disease or disorder first appeared as confirmed by the participant's/subject's medical history obtained by a physician Date (and time if applicable and known) the symptoms for the disease or disorder first appeared as confirmed by the participant's/subject's medical history obtained by a physician Date of first symptoms 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 2022-06-01 10:41:43.0 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events

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C12651 Oosterhuis score OosterhiusScore Oosterhuis score for Myasthenia Gravis Oosterhuis score for myasthenia gravis Oosterhius score 0;1;2;3;4;5 Remission, no medication;Minimal signs and sympotms;Mildly disabled;Moderately disabled;Severely disabled;Respiratory supported needed Numeric Values

Taken at the maximum severity of Myasthenia Gravis symptoms

Oosterhuis HJGH. The natural course of myasthenia gravis: a long-term followup study. J Neurol Neurosurg Psychiatry 1989;52:1121-1127. Oosterhuis HJ. Myasthenia gravis. A survey. Clin Neurol Neurosurg 1981;83:105-35. Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C08007 Diagnosis first given date and time DiagnosFirstGivnDateTime Date (and time if applicable and known) the participant/subject was initially diagnosed with the disease or disorder Date (and time if applicable and known) the participant/subject was initially diagnosed with the disease or disorder Date of diagnosis 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 11:38:01.2 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events

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C18802 Symptom first experienced other text SymptmFirstExpOTH The free-text field related to 'Symptom first experienced text' specifying other text. First symptom of the disease/disorder experienced by the participant/subject The free-text field related to 'Symptom first experienced text' specifying other text. First symptom of the disease/disorder experienced by the participant/subject What were the first symptoms Alphanumeric

Describe using free text the first symptom(s) that appeared

No references available Adult;Pediatric Core 3.00 2013-07-24 21:00:23.88 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events 4000

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C12642 Symptom first experienced distribution category SymptmFirstExpDistrCat System or region of the body that exhibited the first symptoms of the disease/disorder System or region of the body that exhibited the first symptoms of the disease/disorder Initial distribution of symptoms Ocular;Limb;Bulbar;Respiratory;Other, specify Ocular;Limb;Bulbar;Respiratory;Other, specify Alphanumeric

Choose all that apply

No references available Adult;Pediatric Core 3.00 2013-07-24 21:00:23.88 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events

Multiple Pre-Defined Values Selected

C18865 Symptom first experienced distribution other text SymptmFirstExpDistrOTH The free-text field related to 'Symptom first experienced distribution category' specifying other text. System or region of the body that exhibited the first symptoms of the disease/disorder The free-text field related to 'Symptom first experienced distribution category' specifying other text. System or region of the body that exhibited the first symptoms of the disease/disorder Other, specify Alphanumeric

Choose all that apply

No references available Adult;Pediatric Core 3.00 2013-07-24 21:00:23.88 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events 4000

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C12643 Myasthenia Gravis Foundation of America (MGFA) classification type MGFAClassTyp The Myasthenia Gravis Foundation of America (MGFA) classification of the maximum severity of Myasthenia Gravis symptoms The Myasthenia Gravis Foundation of America (MGFA) classification of the maximum severity of Myasthenia Gravis symptoms MGFA class Class I;Class IIa;Class IIb;Class IIIa;Class IIIb;Class IVa;Class IVb;Class V Class I;Class IIa;Class IIb;Class IIIa;Class IIIb;Class IVa;Class IVb;Class V Alphanumeric

Choose one

No references available Adult;Pediatric Core 3.00 2013-07-24 21:00:23.88 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events

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 Participant/Subject's total score for the Fondazione Istituto Neurologico "Carlo Besta" (INNCB) Myasthenia Gravis Scale INNCB MG scale Numeric Values

Taken at the maximum severity of Myasthenia Gravis symptoms

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events

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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 score Numeric Values

Taken at the maximum severity of Myasthenia Gravis symptoms

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events

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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 the maximum severity of Myasthenia Gravis symptoms

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 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events

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 the maximum severity of Myasthenia Gravis symptoms

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 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events

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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 the maximum severity of Myasthenia Gravis symptoms

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 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events

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) Participant/Subject's Myasthenia Gravis Activities of Daily Living (MG-ADL) score (0-24) MG ADL score Numeric Values

Taken at the maximum severity of Myasthenia Gravis symptoms

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 Medical History of MG - MG History of Disease/Injury Event Disease/Injury Related Events

Free-Form Entry

0 24
CSV