CDE Detailed Report

Disease: Multiple Sclerosis
Sub-Domain: Classification
CRF: Diagnosis and Disease Characteristics

Displaying 1 - 30 of 30
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
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

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

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;Recurrent optic neuritis;Recurrent myelitis;Unknown;Other, specify Monophasic;Relapsing;Recurrent optic neuritis;Recurrent myelitis;Unknown;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

Single Pre-Defined Value Selected

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

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

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 Optic neuritis;Acute myelitis;Contiguous spinal cord lesion on MRI >= 3 vertebral segments;Brain MRI not meeting diagnostic criteria for MS;NMO-IgG seropositive;NMO IgG seronegative;NMO IgG sero status unknown Optic neuritis;Acute myelitis;Contiguous spinal cord lesion on MRI >= 3 vertebral segments;Brain MRI not meeting diagnostic criteria for MS;NMO-IgG seropositive;NMO IgG seronegative;NMO IgG sero status unknown 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

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

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

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

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

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

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

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

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

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

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 Presence of encephalopathy (behavioral change or alteration in consciousness);Improvement by clinical exam, MRI or both after acute event;Multifocal lesions predominantly involving white matter;New event of ADEM, 3 or more months with recurrence of the initial symptoms and signs (recurrent ADEM);ADEM followed by a new clinical event also meeting criteria for ADEM, but involving anatomic areas of the CNS Presence of encephalopathy (behavioral change or alteration in consciousness);Improvement by clinical exam, MRI or both after acute event;Multifocal lesions predominantly involving white matter;New event of ADEM, 3 or more months with recurrence of the initial symptoms and signs (recurrent ADEM);ADEM followed by a new clinical event also meeting criteria for ADEM, but involving anatomic areas of the CNS 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

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

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 Supplemental 3.00 2013-07-25 08:54:08.2 Diagnosis and Disease Characteristics Classification Disease/Injury Related Events

Free-Form Entry

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

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

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 Supplemental 3.00 2013-07-24 11:38:01.2 Diagnosis and Disease Characteristics Classification Disease/Injury Related Events

Free-Form Entry

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

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

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

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;PRMS, Progressive disease from onset, with clear acute relapses, with or without full recovery, periods between relapses characterized by continuing progression 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 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];Relapsing Remitting Multiple Sclerosis, 1 attack, objective clinical evidence of 1 lesion (clinically isolated syndrome) [Dissemination in space and time, demonstrated by: >= 1 T2 lesion in at least 2 of 4 MS-typical regions of the CNS (periventricular, juxtacortical, infratentorial, or spinal cord)| and For DIT: Simultaneous presence of 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];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 lesions in the MS-characteristic (periventricular, juxtacortical, 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;Progressive Relapsing Multiple Sclerosis, Progressive disease from onset, with clear acute relapses, with or without full recovery, periods between relapses characterized by continuing progression 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

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 Sclerosis. 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

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

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

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

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:
Clinical trials; Outcome studies

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

CSV