CDE Detailed Report

Disease: content
Subdomain Name: Classification
CRF: welcome

Displaying 1 - 26 of 26
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
C58666 Communication type CommunicationTyp Type of communication as indicated by the Communication Function Classification System (CFCS) Type of communication as indicated by the Communication Function Classification System (CFCS) Communication CFCS Level I;CFCS Level II;CFCS Level III;CFCS Level IV;CFCS Level V;Unknown CFCS Level I;CFCS Level II;CFCS Level III;CFCS Level IV;CFCS Level V;Unknown Alphanumeric

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CFCS Level I: A person independently and effectively alternates between being a sender and receiver of information with most people in most environments
CFCS Level II: A person independently alternates between being a sender and receiver with most people in most environments, but the conversation may be slower
CFCS Level III: A person usually communicates effectively with familiar communication partners, but not unfamiliar partners, in most environments
CFCS Level IV: The person is not always consistent at communicating with familiar communication partners
CFCS Level V: A person is seldom able to communicate effectively even with familiar people

 Hidecker MJ, Paneth N, Rosenbaum PL, Kent RD, Lillie J, Eulenberg JB, Chester K Jr, Johnson B, Michalsen L, Evatt M, Taylor K. Developing and validating the Communication Function Classification System for individuals with cerebral palsy. Dev Med Child Neurol. 2011;53(8):704-710. Adult;Pediatric Supplemental-Highly Recommended 1.00 2020-01-02 12:28:35.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C00001 Gestational age value GestatnlAgeVal Time elapsed in weeks between the first day of the last normal menstrual period and the day of delivery of the participant/subject Time elapsed in weeks between the first day of the last normal menstrual period and the day of delivery of the participant/subjec Gestational age Numeric Values

Record the gestational age of the participant/subject in weeks and days. This element is intended for pediatric clinical studies.

 Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Participant Condition Characteristics Classification Disease/Injury Related Events

Free-Form Entry

 0 52 week 3192017
C58661 Post-neonatal specific exact cause text PostNeonaSpecExactTxt Text describing the cause of the post-neonatal injury or abnormality Text describing the cause of the post-neonatal injury or abnormality Specific cause(s) if known Alphanumeric Adult;Pediatric Supplemental 1.00 2020-01-02 11:28:52.0 Participant Condition Characteristics Classification Disease/Injury Related Events 255

Free-Form Entry
C58673 Respiratory ventilation support assist indicator RespirVentaltnSuppAsstInd Indicator of whether respiratory support and ventilation assistance of the participant/subject Indicator of whether respiratory support and ventilation assistance of the participant/subject Respiratory support / ventilation assist No;Yes No;Yes Alphanumeric

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 Adult;Pediatric Supplemental 1.00 2020-01-03 14:32:37.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C05460 Seizure indicator SeizInd Indicator of seizure activity Indicator of seizure activity Seizures/Epilepsy Yes;No;Suspected;Unknown Yes;No;Suspected;Unknown Alphanumeric

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 Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Participant Condition Characteristics Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C58662 Predominant MRI brain pattern type PredomMRIBrainPatternTyp Type of predominant brain pattern associated with MRI findings Type of predominant brain pattern associated with MRI findings Predominant Brain Pattern (MRI) Maldevelopments;Miscellaneous;Normal;Predominately gray matter injury;Predominately white matter injury Maldevelopments;Miscellaneous;Normal;Predominately gray matter injury;Predominately white matter injury Alphanumeric

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MRI Classification System (MRICS)
A. Maldevelopments include:A1 Disorders of proliferation, migration or organization;A2 Other malformations (among others: holoprosencephaly, Dandy Walker malformation, corpus callosum agenesis, cerebellar hypoplasia…)
B. Predominant white matter injury: B1 Periventricular leucomalacia (PVL) (mild / severe); B2 Sequelae of intraventricular hemorrhage (IVH) or periventricular hemorrhagic infarction (PVHI); B3 Combination of PVL and IVH sequelae
C. Predominant grey matter injury: C1 Basal ganglia/thalamus lesions (mild/moderate/severe); C2 Cortical-subcortical lesions only (watershed lesions in parasagittal distribution / multicystic encephaliamalacia) not covered by C3, arterial infarctions; C3 Arterial infarctions: (middle cerebral artery/other)
D. Miscellaneous (among others: cerebellar atrophy, cerebral atrophy, delayed myelination, ventriculomegaly not covered by B, hemorrhage not covered by B, brainstem lesions, calcifications)
E. Normal

 Himmelmann K, Horber V, De La Cruz J, Horridge K, Mejaski-Bosnjak V, Hollody K, Kr?geloh-Mann I; SCPE Working Group. MRI classification system (MRICS) for children with cerebral palsy: development, reliability, and recommendations. Dev Med Child Neurol. 2017;59(1):57-64.<br />SCPE Collaborative Group. Surveillance of cerebral palsy in Europe: a collaboration of cerebral palsy surveys and registers. Dev Med Child Neurol. 2000;42:816-824. Adult;Pediatric Supplemental-Highly Recommended 1.00 2020-01-02 11:35:24.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C58674 Respiratory ventilation support assist type RespirVentaltnSuppAsstTyp Type of respiratory support / ventilation assist type used by the participant/subject Type of respiratory support / ventilation assist type used by the participant/subject If yes, indicate type (Choose all that apply) CPAP/BiPAP;Mucus clearance device;Other, specify;Oxygen at home;Tracheostomy;Unknown;Ventilator CPAP/BiPAP;Mucus clearance device;Other, specify;Oxygen at home;Tracheostomy;Unknown;Ventilator Alphanumeric

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 No references available. Adult;Pediatric Supplemental 1.00 2020-01-03 14:36:40.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C19500 Assessment performed date AssessmentPerformedDate The date of assessment of the examination being performed The date of assessment of the examination being performed Date of assessment Date or Date & Time Adult;Pediatric Supplemental 1.00 2014-06-18 08:10:12.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Free-Form Entry
C58663 Cerebral palsy gross motor function type CPGrossMotorFuncTyp Type of gross motor function as indicated by the Gross Motor Function Classification System (GMFC) scale Type of gross motor function as indicated by the Gross Motor Function Classification System (GMFC) scale CP Gross Motor Function GMFCS Level I;GMFCS Level II;GMFCS Level III;GMFCS Level IV;GMFCS Level V;Unknown GMFCS Level I;GMFCS Level II;GMFCS Level III;GMFCS Level IV;GMFCS Level V;Unknown Alphanumeric

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GMFCS Level I: Children walk at home, school, outdoors and in the community. They can climb stairs without the use of a railing. Children perform gross motor skills such as running and jumping, but speed, balance and coordination are limited
GMFCS Level II: Children walk in most settings and climb stairs holding onto a railing. They may experience difficulty walking long distances and balancing on uneven terrain, inclines, in crowded areas or confined spaces. Children may walk with physical assistance, a hand-held mobility device or use wheeled mobility over long distances. Children have only minimal ability to perform gross motor skills such as running and jumping
GMFCS Level III: Children walk using a hand-held mobility device in most indoor settings. They may climb stairs holding onto a railing with supervision or assistance. Children use wheeled mobility when traveling long distances and may self-propel for shorter distances
GMFCS Level IV: Children use methods of mobility that require physical assistance or powered mobility in most settings. They may walk for short distances at home use powered mobility or a body support walker when positioned. At school, outdoors and in the community, children are transported in a manual wheelchair or use powered mobility
GMFCS Level V: Children are transported in a manual wheelchair in all settings. Children are limited in their ability to maintain antigravity head and trunk postures and control leg and arm movements

 Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997;39(4):214-223. <br /><br />Palisano RJ, Rosenbaum P, Bartlett D, Livingston MH. Content validity of the expanded and revised Gross Motor Function Classification System. Dev Med Child Neurol. 2008;50(10):744-750. Adult;Pediatric Supplemental-Highly Recommended 1.00 2020-01-02 12:14:50.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C58675 Respiratory ventilation support assist other type text RespirVentaltnSupAsstOthTypTxt Text describing another type of respiratory ventilation or support assist used by participant/subject Text describing another type of respiratory ventilation or support assist used by participant/subject Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2020-01-03 14:43:09.0 Participant Condition Characteristics Classification Disease/Injury Related Events 255

Free-Form Entry
C58653 Cerebral palsy predominant motor type CPPredominantMotorTyp Type of predominant neuromotor movement experienced by the participant/subject Type of predominant neuromotor movement experienced by the participant/subject CP Predominant Motor Type Spastic;Dyskinetic-Dystonia;Dyskinetic-Choreoathetosis;Ataxic;Hypotonic Spastic;Dyskinetic-Dystonia;Dyskinetic-Choreoathetosis;Ataxic;Hypotonic Alphanumeric

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 SCPE Collaborative Group. Surveillance of cerebral palsy in Europe: a collaboration of cerebral palsy surveys and registers. Dev Med Child Neurol. 2000;42:816-824. Adult;Pediatric Supplemental-Highly Recommended 1.00 2020-01-02 10:27:12.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C58664 Cerebral palsy fine motor function type CPFineMotorFuncTyp Type of fine motor function as indicated by the Bimanual Fine Motor Function (BFMF) scale Type of fine motor function as indicated by the Bimanual Fine Motor Function (BFMF) scale CP Fine Motor Function BFMF Level I;BFMF Level II;BFMF Level III;BFMF Level IV;BFMF Level V;Unknown BFMF Level I;BFMF Level II;BFMF Level III;BFMF Level IV;BFMF Level V;Unknown Alphanumeric

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BFMF Level I: One hand: manipulates without restrictions. The other hand: manipulates without restrictions or limitations in more advanced fine motor skills
BFMF Level II: (a) One hand: manipulates without restrictions. The other hand: only ability to grasp or hold (b) Both hands: limitations in more advance fine motor skills
BFMF Level III: (a) One hand: manipulates without restrictions. The other hand no functional ability (b) One hand: limitations in more advanced fine motor skills. The other hand: only ability to grasp or worse
BFMF Level IV: (a) Both hands: only ability to grasp (b) One hand: only ability to grasp. The other hand: only ability to hold or worse
BFMF Level V: Both hands: only ability to hold or worse

 Elvrum AG, Beckung E, S?ther R, Lydersen S, Vik T, Himmelmann K. Bimanual Capacity of Children With Cerebral Palsy: Intra- and Interrater Reliability of a Revised Edition of the Bimanual Fine Motor Function Classification. Phys Occup Ther Pediatr. 2017;37(3):239-251. <br /><br />Elvrum AK, Andersen GL, Himmelmann K, Beckung E, &Ouml;hrvall AM, Lydersen S, Vik T. Bimanual Fine Motor Function (BFMF) Classification in Children with Cerebral Palsy: Aspects of Construct and Content Validity. Phys Occup Ther Pediatr. 2016;36(1):1-16. Adult;Pediatric Supplemental-Highly Recommended 1.00 2020-01-02 12:19:04.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C58654 Cerebral palsy secondary motor type CPSecondaryMotorTyp Type of secondary neuromotor movement experienced by the participant/subject Type of secondary neuromotor movement experienced by the participant/subject CP Secondary Motor Type Spastic;Dyskinetic-Dystonia;Dyskinetic-Choreoathetosis;Ataxic;Hypotonic Spastic;Dyskinetic-Dystonia;Dyskinetic-Choreoathetosis;Ataxic;Hypotonic Alphanumeric

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 SCPE Collaborative Group. Surveillance of cerebral palsy in Europe: a collaboration of cerebral palsy surveys and registers. Dev Med Child Neurol. 2000;42:816-824. Adult;Pediatric Supplemental-Highly Recommended 1.00 2020-01-02 10:27:12.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C58665 Cerebral palsy upper limb function type CPUpperLimbFuncTyp Type of upper limb function as indicated by the Manual Ability Classification System (MACS) scale Type of upper limb function as indicated by the Manual Ability Classification System (MACS) scale CP Fine Motor Function MACS Level I;MACS Level II;MACS Level III;MACS Level IV;MACS Level V;Unknown MACS Level I;MACS Level II;MACS Level III;MACS Level IV;MACS Level V;Unknown Alphanumeric

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MACS Level I: Handles objects easily and successfully. At most, limitations in the ease of performing manual tasks requiring speed and accuracy. However, any limitations in manual abilities do not restrict independence in daily activities
MACS Level II: Certain activities may be avoided or be achieved with some difficulty, alternative ways of performance might be used but manual abilities do not usually restrict independence in daily activities
MACS Level III: Handles objects with difficulty, needs help to prepare and/or modify activities. The performance is slow and achieved with limited success regarding quality and quantity. Activities are performed independently if they have been set up or adapted
MACS Level IV: Handles a limited selection of easily managed objects in adapted situations. Performs parts of activities with effort and with limited success. Requires continuous support and assistance and/or adapted equipment, for even partial achievement of the activity
MACS Level V: Does not handle objects and has severely limited ability to perform even simple actions. Requires total assistance

 Eliasson AC, Krumlinde-Sundholm L, R&Ouml;sblad B, Beckung E, Arner M, &Ouml;hrvall AM, Rosenbaum P. The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol. 2006;48(7):549-554. Adult;Pediatric Supplemental-Highly Recommended 1.00 2020-01-02 12:22:58.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C58655 Cerebral palsy distribution type CPDistributionTyp Type of condition distribution (spasticity subtype) experienced by the participant/subject Type of condition distribution (spasticity subtype) experienced by the participant/subject CP Distribution Primarily bilateral;Primarily unilateral Primarily bilateral;Primarily unilateral Alphanumeric

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 SCPE Collaborative Group. Surveillance of cerebral palsy in Europe: a collaboration of cerebral palsy surveys and registers. Dev Med Child Neurol. 2000;42:816-824. Adult;Pediatric Supplemental 1.00 2020-01-02 10:38:16.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C58667 Eating drinking type EatingDrinkingTyp Type of eating and drinking as indicated by the Eating and Drinking Classification System (EDACS) Type of eating and drinking as indicated by the Eating and Drinking Classification System (EDACS) Eating and Drinking EDACS Level I;EDACS Level II;EDACS Level III;EDACS Level IV;EDACS Level V;Unknown EDACS Level I;EDACS Level II;EDACS Level III;EDACS Level IV;EDACS Level V;Unknown Alphanumeric

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EDACS Level I: Eats and drinks safely and efficiently
EDACS Level II: Eats and drinks safely but with some limitations to efficiency
EDACS Level III: Eats and drinks with some limitations to safely, there many be limitations to efficiency
EDACS Level IV: Eats and drinks with significant limitations to safety
EDACS Level V: Unable to eat and drink safely - tube feeding may be considered to provide nutrition

 Sellers D, Mandy A, Pennington L, Hankins M, Morris C. Development and reliability of a system to classify the eating and drinking ability of people with cerebral palsy. Dev Med Child Neurol. 2014;56(3):245-251. Adult;Pediatric Supplemental-Highly Recommended 1.00 2020-01-03 09:22:22.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C58656 Cerebral palsy distribution primarily unilateral type CPDistribPrimarlyUnilatTyp Type of CP distribution primarily unilateral subtype experienced by the participant/subject Type of CP distribution primarily unilateral subtype experienced by the participant/subject Primarily unilateral Hemiplegia;Monoplegia Hemiplegia;Monoplegia Alphanumeric

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 No references available. Adult;Pediatric Supplemental 1.00 2020-01-02 10:42:20.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C58668 Intellectual impairment type IntellectualImpairTyp Type of intellectual impairment of the participant/subject Type of intellectual impairment of the participant/subject Intellectual impairment Mild intellectual impairment;Moderate intellectual impairment;Normal/No intellectual impairment;Profound intellectual impairment;Severe intellectual impairment;Unknown Mild intellectual impairment;Moderate intellectual impairment;Normal/No intellectual impairment;Profound intellectual impairment;Severe intellectual impairment;Unknown Alphanumeric

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Normal/No intellectual impairment
Mild intellectual impairment: (Approximate IQ range 50-69) Can live independently with minimum levels of support
Moderate intellectual impairment: (Approximate IQ range 36-49): Independent living may be achieved with moderate levels of support, such as those available in group homes
Severe intellectual impairment: (Approximate IQ range 20-35) Requires daily assistance with self-care activities and safety supervision
Profound intellectual impairment: (IQ

American Psychiatric Association (1994). Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition). Washington, DC, American Psychiatric Association. Adult;Pediatric Supplemental 1.00 2020-01-03 09:29:16.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C58657 Hemiplegia laterality type HemiplegiaLateralTyp Hemiplegia laterality of interest Hemiplegia laterality of interest Hemiplegia Left;Right Left;Right Alphanumeric

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 No references available. Adult;Pediatric Supplemental 1.00 2020-01-02 10:46:22.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C58669 Visual impairment indicator VisualImpairmentInd Indicator of whether participant has visual impairment Indicator of whether participant has visual impairment Visual impairment No;Yes;Unknown No;Yes;Unknown Alphanumeric

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 Adult;Pediatric Supplemental 1.00 2020-01-03 09:40:06.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C58658 Monoplegia laterality type MonoplegiaLateralTyp Monoplegia laterality of interest Monoplegia laterality of interest Monoplegia Left;Right Left;Right Alphanumeric

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 No references available. Adult;Pediatric Supplemental 1.00 2020-01-02 10:46:22.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C58670 Visual impairment severity type VisualImpairmentSeverityTyp Type of visual impairment severity of the participant/subject Type of visual impairment severity of the participant/subject If yes, severity of visual impairment? Normal;Some impairment;Blind;Unknown Normal;Some impairment;Blind;Unknown Alphanumeric

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Normal: No impairment
Some impairment: some visual impairment (wears glasses)
Blind: Functionally blind (may have light perception, ability to see colour differences, see shadows but unable to use)
Unknown: Visual status unknown

 No references available. Adult;Pediatric Supplemental 1.00 2020-01-03 09:44:51.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C58659 Cerebral palsy distribution primarily bilateral type CPDistribPrimarlyBilatTyp Type of CP distribution primarily bilateral subtype experienced by the participant/subject Type of CP distribution primarily bilateral subtype experienced by the participant/subject Primarily bilateral Diplegia;Quadriplegia;Triplegia Diplegia;Quadriplegia;Triplegia Alphanumeric

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 No references available. Adult;Pediatric Supplemental 1.00 2020-01-02 11:15:52.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C58671 Hearing impairment indicator HearingImpairmntInd Indicator of whether participant/subject has hearing impairment Indicator of whether participant/subject has hearing impairment Hearing impairment No;Yes;Unknown No;Yes;Unknown Alphanumeric

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 Adult;Pediatric Supplemental 1.00 2020-01-03 09:50:47.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C58660 Timing injury abnormality type TimeInjAbnormalTyp Type as related to the point in time of injury or abnormality Type as related to the point in time of injury or abnormality Timing of injury/abnormality Perinatal;Prenatal;Post-neonatal (after 28 days, before age 2);Unknown Perinatal;Prenatal;Post-neonatal (after 28 days, before age 2);Unknown Alphanumeric

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 No references available. Adult;Pediatric Supplemental-Highly Recommended 1.00 2020-01-02 11:20:45.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C58672 Hearing impairment severity type HearingImpairmentSeverityTyp Type of hearing impairment severity of the participant/subject Type of hearing impairment severity of the participant/subject Severity of hearing impairment Normal;Some impairment;Bilateral deafness;Unknown Normal;Some impairment;Bilateral deafness;Unknown Alphanumeric

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Normal: No impairment
Some Impairment: Partial inability to hear
Bilateral deafness: Total inability to hear, with or without amplification
Unknown: Hearing status unknown

 No references available. Adult;Pediatric Supplemental 1.00 2020-01-03 14:25:08.0 Participant Condition Characteristics Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
CSV