CDE Detailed Report
Disease: Multiple Sclerosis
Subdomain Name: Classification
CRF: Diagnosis and Disease Characteristics
Displaying 1 - 33 of 33
Subdomain Name: Classification
CRF: Diagnosis and Disease Characteristics
Displaying 1 - 33 of 33
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C59004 | Relapsing NMO spectrum disorder type | RlpseNmoSpcDsrdrTyp | Type of relapsing Neuromyelitis Optica (NMO) spectrum disorder the participant/subject is experiencing | Type of relapsing Neuromyelitis Optica (NMO) spectrum disorder the participant/subject is experiencin | If Relapsing | Recurrent optic neuritis;Combination;Recurrent transverse myelitis | Recurrent optic neuritis;Combination;Recurrent transverse myelitis | Alphanumeric | Wingerchuck, D.M., Banwell, B., Bennett, J.L., Cabre, P., Carroll, W., Chitnis, T., …Weinshenker, B.G. (2015) International consensus diagnostic criteria for neuromyelitis optica spectrum disorders Neurology, 85(2): 177-189. doi:10.1212/WNL.0000000000001729 | Adult;Pediatric | Supplemental | 1.00 | 2021-03-23 11:48:17.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C59002 | Relapsing remitting multiple sclerosis status | RRMSStat | The status of the participant/subjects disease course of relapsing remitting multiple sclerosis (MS) | The status of the participant/subjects disease course of relapsing remitting multiple sclerosis (MS | If RRMS, indicate if active or not active: | Active;Not active | Active;Not active | Alphanumeric | Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014;83(3):278-286. doi:10.1212/WNL.0000000000000560 | Adult;Pediatric | Supplemental | 1.00 | 2021-03-23 10:09:11.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C59003 | Progressive multiple sclerosis status | PrgrssveMSStat | The status of the participant/subjects disease course of progressive Multiple Sclerosis (MS) | The status of the participant/subjects disease course of progressive Multiple Sclerosis (MS | If SPMS or PPMS, indicate if: | Not active and without progression (stable disease);Active and with progression;Active but without progression;Not active but with progression | Not active and without progression (stable disease);Active and with progression;Active but without progression;Not active but with progression | Alphanumeric | Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014;83(3):278-286. doi:10.1212/WNL.0000000000000560 | Adult;Pediatric | Supplemental | 1.00 | 2021-03-23 10:26:15.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C02411 | Laterality type | LatTyp | Laterality type relative to the anatomic site of the body examined or affected | Laterality type relative to the anatomic site of the body examined or affected | Specify laterality | Bilateral;Left;Right;Unknown | Bilateral;Left;Right;Unknown | Alphanumeric |
For MS: Only answered if "Optic neuritis" is answered for "If one of the NMO spectrum disorder types above, choose all that apply" For SCI: This element, and the 'SCI Classification motor exam anatomic site' and 'SCI Classification sensory exam anatomic site' elements as applicable, should be used with the subsequent motor and sensory grades and scores to identify with which anatomic site and side (i.e., left or right) each motor and sensory grade/score is associated. To be answered for each location on the body The laterality and anatomic site of each pain problem should be documented. Record the fixed dynamometry result for each muscle and side Record the hand held dynamometry result for each muscle and side Record the grip strength results for each hand side If muscle is not tested, check box in Not Tested column. If muscle is tested, do not check box in Not Tested column. |
Duhaime AC, Gean AD, Haacke EM, Hicks R, Wintermark M, Mukherjee P, Brody D, Latour L, Riedy G; Common Data Elements Neuroimaging Working Group Members, Pediatric Working Group Members. Common data elements in radiologic imaging of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1661-6. Haacke, E.M., Duhaime, A.C., Gean, A.D., Riedy, G., Wintermark, M., Mukherjee, P., Brody, D.L., DeGraba, T., Duncan, T.D., and Elovic, E. (2010). Common data elements in radiologic imaging of traumatic brain injury. Journal of Magnetic Resonance Imaging 32:516-543. Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele J-J. International urinary tract imaging basic spinal cord injury data set. Spinal Cord 2009 May;47(5):379-83. WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Used with permission of the American Spinal Injury Association: International Standards for Neurological Classification of Spinal Cord Injury, revised 2002: Atlanta, GA. Karlsson AK, Krassioukov A, Alexander MS, Donovan W, Biering-SØrensen F. International Spinal Cord Injury Skin and Thermoregulation Function Basic Data Set. Spinal Cord. 2012; 50(7):512-6. Pediatric Stroke Outcome Measure-Neuro Exam. Children's Stroke Program, Hospital for Sick Children, Toronto, Canada. G. deVeber, D. MacGregor, R. Curtis, T. Soman, R. Ichord et al. Version October 2003, format revised November 2005. Beck M, Giess R, Wuerffel W, Magnus T, Ochs, G, Toyka KV. Comparison of Maximal Voluntary Isometric Contraction and Drachman's Hand-Held Dynamometry in Evaluating Patients with Amyotrophic Lateral Sclosis. Muscle Nerve. 1999; 22: 1265-1270. Bohannon RW. Hand-Held Dynamometry; Stability of Muscle Strength Over Multiple Measurements. Clinical Biomechanics. 1986: 2:74-77. Wang CY, Olson SL, Protas EJ. Test-Retest Strength Reliability: Hand-Held Dynamometry in Community-Dwelling Elderly Faller. Arch Phys Med Rehabil. 2002; 83: 811-5. Shefner J, Cudkowicz ME, Maragakis N, Cedarbaum JM, Lee J, Jones D, Watson ML, Shaver K, Chen M, Saikali K, Mao J, Russell AK, Hansen L, Malik F, Wolff AA, for the NEALS/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in Amyotrophic Lateral Sclerosis. (submitted for publication). | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C16126 | Acute disseminated encephalomyelitis (ADEM) characteristics type | AdemCharTyp | The signs and characteristics of acute disseminated encephalomyelitis (ADEM) experienced by the participant/subject | The signs and characteristics of acute disseminated encephalomyelitis (ADEM) experienced by the participant/subject | Signs/Characteristics experienced | ADEM followed by a new clinical event also meeting criteria for ADEM, but involving different anatomic areas of the CNS;Improvement by clinical exam, MRI or both after acute event;Multifocal lesions predominantly involving white matter;New event of ADEM, 3 or more months after the initial event with recurrence of the initial symptoms and signs (recurrent ADEM);Presence of encephalopathy (behavioral change or alteration in consciousness) | ADEM followed by a new clinical event also meeting criteria for ADEM, but involving different anatomic areas of the CNS;Improvement by clinical exam, MRI or both after acute event;Multifocal lesions predominantly involving white matter;New event of ADEM, 3 or more months after the initial event with recurrence of the initial symptoms and signs (recurrent ADEM);Presence of encephalopathy (behavioral change or alteration in consciousness) | Alphanumeric |
Choose all that apply. See IPMSSG definitions for details regarding new event for ADEM or new clinical event options. |
Krupp LB, Banwell B and Tenembaum S. Consensus definitions proposed for pediatric multiple sclerosis and related disorders. Neurology. 2007; 68: S7-12. | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Multiple Pre-Defined Values Selected |
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| C16139 | Localization region anatomic site | LoclzRegnAntmicSite | Regions of possible onset of clinical event experience by participant/subject | Regions of possible onset of clinical event experience by participant/subject | Localization of clinical event | Optic nerve;Cerebrum;Brainstem/Cerebellar;Spinal Cord | Optic nerve;Cerebrum;Brainstem/Cerebellar;Spinal Cord | Alphanumeric |
No additional instructions |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Multiple Pre-Defined Values Selected |
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| C05404 | Symptom onset date and time | SymptmOnsetDateTime | Date (and time, if applicable and known) reported for onset of participant's/subject's symptoms | Date (and time, if applicable and known) reported for onset of participant's/subject's symptoms | Month/Year 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.). Symptom is referring to dysphasia, dysarthria, focal weakness, shortness of breath, gait disturbance. Symptom does NOT refer to cramps, fatigue or fasciculati The time of symptom discovery is either the time at which the patient was first noted by another person to have stroke symptoms or the self-reported time by an individual who may not be accurate or reliable in their assessment of stroke symptoms onset (e.g., in the setting of neglect or anosagnosia, or aphasia). When the event is witnessed by another person, then the time of discovery is identical to the time of last known well; however, when unwitnessed or self-reported by an unreliable patient, this time of discovery will be later chronologically than the time last known well. For Multiple Sclerosis studies, it is sufficient to just record the month and year of first symptoms in the format MM/YYYY. |
Get With The Guidelines (GWTG) Stroke Patient Management Tool Coding Instructions (Updated on 11/4/2009); Paul Coverdell National Acute Stroke Registry | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Free-Form Entry |
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| C16127 | CNS other demyelinating disorder name | CNSOthDemyltsDisorderNme | Name of other central nervous system (CNS) demyelinating disorder experienced by the participant/subject | Name of other CNS demyelinating disorder experienced by the participant/subject | Specify disorder | Alphanumeric |
Specify type of disorder |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events | 255 |
Free-Form Entry |
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| C16140 | Localization region indicator | LoclzRegnInd | The presence or absence of symptoms experienced by the participant/subject in specific localization regions | The presence or absence of symptoms experienced by the participant/subject in specific localization regions | Localization of clinical event | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Answered for all localization regions |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| 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 | Year of first diagnosis | Date or Date & Time |
For Multiple Sclerosis studies, it is sufficient to just record the year of first diagnosis in the format YYYY. 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 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Free-Form Entry |
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| C16128 | CNS other demyelinating disorder type | CNSOthDemyltsDisorderTyp | Type of other central nervous system (CNS) demyelinating disorder experienced by the participant/subject | Type of other CNS demyelinating disorder experienced by the participant/subject | Type | Monophasic;Unknown;Other, specify;Recurrent | Monophasic;Unknown;Other, specify;Recurrent | Alphanumeric |
No additional instructions |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C16141 | Observation method of localization region type | ObsMethdLoczRegTyp | Observation method used in listed regions | Observation method used in listed regions | Specify observation method (choose all that apply) | Exam;MRI;History;Unknown | Exam;MRI;History;Unknown | Alphanumeric |
Choose all that apply for each localization region |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Multiple Pre-Defined Values Selected |
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| C16118 | MS current diagnosis type | MSCurntDiagnosTyp | The current Multiple Sclerosis (MS) diagnosis of the participant/subject | The current MS diagnosis of the participant/subject | What is the current diagnosis | RIS;CIS;MS;NMO;ADEM;Other | Radiologically isolated syndrome;Clinically isolated syndrome;Multiple sclerosis;Neuromyelitis optica spectrum disorder;Acute Disseminated Encephalomyelitis;Other CNS demyelinating disorder | Alphanumeric |
Choose only one. If "MS" is answered, go to question 2 to specify clinical course, then skip to question 6. If "NMO" is answered, go to question 3 to specify clinical course, then skip to question 7. If "ADEM" is answered, go to question 4 to specify clinical course, then skip to question 7. If "Other CNS demyelinating disorder" is answered, go to question 5 to specify clinical course, then skip to question 7. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C16129 | MS diagnostic criterion type | MSDiagnosCriterionTyp | Diagnostic criteria the participant/subject diagnosed with Multiple Sclerosis (MS) fulfills | Diagnostic criteria the participant/subject diagnosed with MS fulfills | Indicate which diagnostic criteria the patient fulfills | RRMS, >= 2 attacks, objective clinical evidence of >= 2 lesions or objective clinical evidence of 1 lesion with reasonable historical evidence of a prior attack;RRMS, >= 2 attacks, objective clinical evidence of 1 lesion;RRMS, 1 attack, objective clinical evidence of >= 2 lesions;RRMS, 1 attack, objective clinical evidence of 1 lesion (clinically isolated syndrome);PPMS, 1 year of disease progression plus 2 of 3 of following: 1) Evidence for DIS in brain based on >= 1 T2 lesions in MS-characteristic regions, 2) Evidence for DIS in spinal cord, 3) Positive CSF;SPMS, Initial RR disease course followed by progression with or without occasional relapses, minor remissions, and plateaus | Relapsing Remitting Multiple Sclerosis, >= 2 attacks, objective clinical evidence of >= 2 lesions or objective clinical evidence of 1 lesion with reasonable historical evidence of a prior attack;Relapsing Remitting Multiple Sclerosis, >= 2 attacks, objective clinical evidence of 1 lesion [Dissemination in space demonstrated by: >= 1 T2 lesion in at least 2 of 4 MS-typical regions of the CNS (periventricular, juxtacortical, infratentorial, or spinal cord)];Relapsing Remitting Multiple Sclerosis, 1 attack, objective clinical evidence of >= 2 lesions [Dissemination in time, demonstrated by: Simultaneous presence of symptomatic or asymptomatic gadolinium-enhancing and nonenhancing lesions at any time, or A new T2 and/or gadolinium-enhancing lesion(s) on follow-up MRI, irrespective of its timing with reference to a baseline scan or CSF-specific oligoclonal bands];Relapsing Remitting Multiple Sclerosis, 1 attack, objective clinical evidence of 1 lesion (clinically isolated syndrome) [Dissemination in space and time, demonstrated by: Additional attack implicating different CNS site,>= 1 T2 lesion in at least 2 of 4 MS-typical regions of the CNS (periventricular, juxtacortical/cortical, infratentorial, or spinal cord)| and For DIT: Simultaneous presence of symptomatic or asymptomatic gadolinium-enhancing and nonenhancing lesions at any time, or A new T2 and/or gadolinium-enhancing lesion(s) on follow-up MRI, irrespective of its timing with reference to a baseline scan, CSF-specific oligoclonal bands];Primary Progressive Multiple Sclerosis, 1 year of disease progression (retrospectively or prospectively determined) plus 2 of 3 of the following: (1) Evidence for DIS in the brain based on >= 1 T2 symptomatic or asymptomatic lesions in the MS-characteristic (periventricular, juxtacortical/cortical, or infratentorial) regions, (2) Evidence for DIS in the spinal cord based on >= 2 T2 lesions in the cord, (3) Positive CSF (isoelectric focusing evidence of oligoclonal bands and/or elevated IgG index);Secondary Progressive Multiple Sclerosis, Initial Relapsing Remitting disease course followed by progression with or without occasional relapses, minor remissions, and plateaus | Alphanumeric |
To be answered by MS participant's/subject's only. Choose only one MS diagnostic criteria. For RRMS, choose only one. The study team should determine when to apply these criteria. |
For RRMS and PPMS: Polman CH, Reingold SC, Banwell B, et al. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Annals of neurology. 2011; 69: 292-302. For SPMS and PRMS: Lublin FD and Reingold SC. Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology. 1996; 46: 907-11. | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C17457 | MS family medical history indicator | MSFamlyMedclHistInd | The indicator for family having medical history of Multiple Sclerosis | The indicator for family having medical history of Multiple Sclerosi | Do you have a family history of MS | Yes;No;Unknown;Not applicable | Yes;No;Unknown;Not applicable | Alphanumeric | No references available | Adult;Pediatric | Core | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C16119 | MS onset course type | MSOnsetCrseTyp | Type of onset experienced by participant/subject diagnosed with MS | Type of onset experienced by participant/subject diagnosed with MS | Onset Course | Relapsing;Progressive | Relapsing;Progressive | Alphanumeric |
No additional instructions |
No references available | Adult;Pediatric | Core | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C16131 | Clinical event occurrence range | ClinEvntOccurenceRng | Timeframe of when clinical event occurred | Timeframe of when clinical event occurred | Did occurrence of onset clinical event occur | Within 1 months post-infection;Within 1 months post-vaccination;Neither | Within 1 months post-infection;Within 1 months post-vaccination;Neither | Alphanumeric |
No additional instructions |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C19047 | Neuromyelitis Optica (NMO) spectrum disorder other text | NMOSpectDisorderOTH | The free-text field related to 'Neuromyelitis Optica (NMO) spectrum disorder type' specifying other text. Type of Neuromyelitis Optica (NMO) spectrum disorder experienced by participant/subject | The free-text field related to 'Neuromyelitis Optica (NMO) spectrum disorder type' specifying other text. Type of Neuromyelitis Optica (NMO) spectrum disorder experienced by participant/subject | Other, specify | Alphanumeric |
No additional instructions |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events | 4000 |
Free-Form Entry |
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| C16120 | MS current disease course type | MSCurntDisesCrseTyp | Current Multiple Sclerosis (MS) disease course the participant/subject is experiencing | Current MS disease course the participant/subject is experiencing | Current Disease Course | Relapsing remitting;Secondary progressive;Primary progressive;Progressive relapsing;Uncertain | Relapsing remitting;Secondary progressive;Primary progressive;Progressive relapsing;Uncertain | Alphanumeric |
Highly recommended for: |
Lublin, F. D., Reingold, S. C., Cohen, J. A., Cutter, G. R., SØrensen, P. S., Thompson, A. J., … Polman, C. H. (2014). Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology, 83(3), 278-286. doi:10.1212/WNL.0000000000000560 | Adult;Pediatric | Core | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C16132 | MS first onset type | MS1stOnsetTyp | Disposition of first onset of event of multiple sclerosis (MS) | Disposition of first onset of event | First onset | Unifocal;Multifocal | Unifocal;Multifocal | Alphanumeric |
Choose only one |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C19048 | Acute disseminated encephalomyelitis (ADEM) clinical course other text | AdemClinCrseOTH | The free-text field related to 'Acute disseminated encephalomyelitis (ADEM) clinical course type' specifying other text. The diagnosed type of acute disseminated encephalomyelitis (ADEM) experienced by the participant/subject | The free-text field related to 'Acute disseminated encephalomyelitis (ADEM) clinical course type' specifying other text. The diagnosed type of acute disseminated encephalomyelitis (ADEM) experienced by the participant/subject | Other, specify | Alphanumeric |
No additional instructions |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events | 4000 |
Free-Form Entry |
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| C16121 | Neuromyelitis Optica (NMO) spectrum disorder type | NMOSpectDisorderTyp | Type of Neuromyelitis Optica (NMO) spectrum disorder experienced by participant/subject | Type of NMO spectrum disorder experienced by participant/subject | Type | Monophasic;Relapsing;Other, specify | Monophasic;Relapsing;Other, specify | Alphanumeric |
No additional instructions |
Wingerchuk DM, Banwell B, Bennett JL, et al. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology. 2015;85(2):177-189. doi:10.1212/WNL.0000000000001729 | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C16133 | Treatment for clinical event indicator | TreatmtClinEvntInd | Indicates whether the participant/subject received treatment for the clinical event | Indicates whether the participant/subject received treatment for the clinical event | Did the patient receive treatment for clinical event | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
No additional instructions |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C19049 | CNS other demyelinating disorder other text | CNSOthDemyltsDisorderOTH | The free-text field related to 'CNS other demyelinating disorder type' specifying other text. Type of other central nervous system (CNS) demyelinating disorder experienced by the participant/subject | The free-text field related to 'CNS other demyelinating disorder type' specifying other text. Type of other central nervous system (CNS) demyelinating disorder experienced by the participant/subject | Other, specify | Alphanumeric |
No additional instructions |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events | 4000 |
Free-Form Entry |
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| C16122 | Neuromyelitis Optica (NMO) spectrum disorder sub-disease type | NMOSpectDisorderSubDiseaseTyp | Details of the Neuromyelitis Optica (NMO) spectrum disorder selected experienced by the participant/subject | Sub-disease of the NMO spectrum disorder selected experienced by the participant/subject | If one of the NMO spectrum disorder types above, choose all that apply | Contiguous spinal cord lesion on MRI >= 3 vertebral segments;Brain MRI not meeting diagnostic criteria for MS;MOG-IgG seropositive;MOG-IgG seronegative;NMO IgG sero status unknown;NMO IgG seronegative;NMO-IgG seropositive;Acute myelitis;Optic neuritis | Contiguous spinal cord lesion on MRI >= 3 vertebral segments;Brain MRI not meeting diagnostic criteria for MS;MOG-IgG seropositive;MOG-IgG seronegative;NMO IgG sero status unknown;NMO IgG seronegative;NMO-IgG seropositive;Acute myelitis;Optic neuritis | Alphanumeric |
Choose all that apply. See NMO 2006 criteria for details regarding contiguous spinal cord lesion option. |
Wingerchuk DM, Lennon VA, Pittock SJ, Lucchinetti CF and Weinshenker BG. Revised diagnostic criteria for neuromyelitis optica. Neurology. 2006; 66: 1485-9. | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Multiple Pre-Defined Values Selected |
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| C16134 | Treatment for clinical event type | TreatmtclinEvntTyp | Type of treatment participant/subject received for clinical event | Type of treatment participant/subject received for clinical event | Indicate treatment (choose all that apply) | IVIg;Plasmapheresis;Steroids | IVIg;Plasmapheresis;Steroids | Alphanumeric |
Choose all that apply |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Multiple Pre-Defined Values Selected |
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| C19050 | Symptoms initial category other text | SymptInitialCategoryOTH | The free-text field related to 'Symptoms initial category type' specifying other text. The body system or other categories describing where initial symptoms were present | The free-text field related to 'Symptoms initial category type' specifying other text. The body system or other categories describing where initial symptoms were present | Other, specify | Alphanumeric |
No additional instructions |
No references available | Adult | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events | 4000 |
Free-Form Entry |
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| C16123 | Acute myelitis segment anatomic site | AcuteMyltsSgmntAntmicSite | The anatomic site(s) of segments in the vertebral column involved in acute myelitis | The anatomic site(s) of segments in the vertebral column involved in acute myelitis | Specify involvement of which segments | Cervical (C);Thoracic (T);Lumbar (L) | Cervical vertebrae are the 7 spinal bones that support the neck;Thoracic vertebrae are the 12 spinal bones that connect to the rib cage;Lumbar vertebrae are the 5 lowest and largest bones of the spinal column. Most of the body's weight and stress falls on the lumbar vertebrae | Alphanumeric |
Choose all that apply. Only answered if "Acute myelitis" is answered for "If one of the NMO spectrum disorder types above, choose all that apply" |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Multiple Pre-Defined Values Selected |
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| C16135 | MS full recovery of relapse within year indicator | MSFullRcvryRlpseYrInd | Indicates whether the participant/subject with Multiple Sclerosis was fully recovered from this relapse/exacerbation within a year | Indicates whether the participant/subject with Multiple Sclerosis was fully recovered from this relapse/exacerbation within a year | Was the patient fully recovered from this relapse within a year | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
No additional instructions |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C16124 | First optic neuritis and first myelitis onset elapsed time value | FstOptcNeuritsMyltsElpsdTypVal | Time between the onset of the first optic neuritis and first myelitis | Time between the onset of the first optic neuritis and first myelitis | Time between onset of first optic neuritis and first myelitis | Numeric Values |
Record the elapsed time between onset of the first optic neuritis and the first myelitis in months, or select N/A if not applicable. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Free-Form Entry |
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| C16137 | Symptoms initial category type | SymptInitialCategoryTyp | The body system or other categories describing where initial symptoms were present | Categories of initial symptoms | Initial symptoms | Vision;Motor;Sensory;Coordination;Bowel/Bladder;Fatigue;Cognitive;Encephalopathy;Other, specify | Vision;Motor;Sensory;Coordination;Bowel/Bladder;Fatigue;Cognitive;Encephalopathy;Other, specify | Alphanumeric |
No additional instructions |
No references available | Adult | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Multiple Pre-Defined Values Selected |
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| C16125 | Acute disseminated encephalomyelitis (ADEM) clinical course type | AdemClinCrseTyp | The diagnosed type of acute disseminated encephalomyelitis (ADEM) experienced by the participant/subject | The diagnosed type of acute disseminated encephalomyelitis (ADEM) experienced by the participant/subject | Type | Monophasic;Unknown;Other, specify;Recurrent;Multiphasic | Monophasic;Unknown;Other, specify;Recurrent;Multiphasic | Alphanumeric |
No additional instructions |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C16138 | Symptoms initial category indicator | SymptInitialCategoryInd | The presence or absence of symptoms first experienced by the participant/subject | The presence or absence of symptoms first experienced by the participant/subject | Initial symptoms | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Answered for all initial symptom categories |
No references available | Adult | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Diagnosis and Disease Characteristics | Classification | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
