CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Assessments and Examinations
CRF: Classification of Seizures

8 results.
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 Source Form Set Form Field Domain CDASH Variable CDASH Definition CDASH Label Controlled Terminology Prompt Essentiality Question Text CDASH imp guidance SDTM IG target csDSR PhenX Data Type CRF Completion Inst SDTMIG Target Var SDTMIG Target Map Codelist Name PVs Pre Pop Value Query Display List Style
C18500 Seizure present status SeizPresentStatus The status indicating whether a classified seizure is present. The status indicating whether a classified seizure is present. Present? No;Possible;Probable;Definite;Unknown;N/A No;Possible;Probable;Definite;Unknown;N/A Alphanumeric Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, Cross JH, van Emde Boas W, Engel J, French J, Glauser TA, Mathern GW, MoshÉ SL, Nordli D, Plouin P, Scheffer IE. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. Epub 2010 Feb 26. Freely available online at: http://www.ilae.org/Visitors/Centre/ctf/ctfoverview.cfm http://www.ilae-epilepsy.org/Visitors/Documents/ClassificationSummaryReportwebAug2009.pdf. Adult;Pediatric Proposed 3.00 2013-07-30 14:29:49.047 Classification of Seizures Assessments and Examinations Physical Examinations

Single Pre-Defined Value Selected

C06005 Data collected date and time DataCollDateTime Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed. Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed. Date form completed 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.).

EPILEPSY: Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, et al. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. http://www.ilae-epilepsy.org/Visitors/Centre/ctf/ctfoverview.cfm Adult;Pediatric Proposed 3.00 2013-07-24 21:00:23.88 Classification of Seizures Assessments and Examinations Physical Examinations

Free-Form Entry

C14125 Seizure unclassifiable classification type SeizUnclassClassTyp Whether the participant/subject has experienced an unclassifiable seizure that is neither focal or generalized. Whether the participant/subject has experienced an unclassifiable seizure that is neither focal or generalized. Unclassified Seizure Type Epileptic spasms, focal or generalized;Seizure type is unclassified;Epileptic spasms, focal or generalized;Seizure type is unclassified Epileptic spasms, focal or generalized;Seizure type is unclassified (If a seizure cannot be adequately classified, it should not be fit into a category to which it does not belong.);Epileptic spasms, focal or generalized;Seizure type is unclassified (If a seizure cannot be adequately classified, it should not be fit into a category to which it does not belong.) Alphanumeric

Choose one for each seizure type or subtype identified.

EPILEPSY: Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, et al. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. http://www.ilae-epilepsy.org/Visitors/Centre/ctf/ctfoverview.cfm Adult;Pediatric Proposed 3.00 2013-08-28 16:08:00.453 Classification of Seizures Assessments and Examinations Physical Examinations

Single Pre-Defined Value Selected

C14126 Seizure classification type SeizClassTyp The type of seizures present by classification. The type of seizures present by classification. Classification of Seizures Generalized;Focal;Unclassified Generalized;Focal;Unclassified seizures are considered unidentifiable due to lack of data and do not fit in to the aforementioned categories for Generalized and Focal Seizures Alphanumeric

Choose all that apply. Each seizure type needs to be answered using the permissible values for the "Seizure type or subtype present likelihood type" data element. It is possible for a participant/subject to have more than one seizure type.

EPILEPSY: Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, et al. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. http://www.ilae-epilepsy.org/Visitors/Centre/ctf/ctfoverview.cfm Adult;Pediatric Proposed 3.00 2013-08-28 16:08:00.453 Classification of Seizures Assessments and Examinations Physical Examinations

Multiple Pre-Defined Values Selected

C14127 Seizure generalized classification type SeizGenClassTyp The type of generalized epileptic seizures, considered to originate at some point within, and rapidly engage, bilaterally distributed networks and may include such bilateral networks as ortical and subcortical structures, but do not necessarily include the entire cortex, experienced by the participant/subject. The type of generalized epileptic seizures, considered to originate at some point within, and rapidly engage, bilaterally distributed networks, experienced by the participant/subject. Generalized Seizure Subtypes Tonic clonic;Absence;Typical;Atypical;Myoclonic absence;Eyelid myoclonia;Myoclonic;Myoclonic atonic;Myoclonic tonic;Clonic;Tonic;Atonic Tonic clonic (in any combination);Absence;Absence-Typical;Absence-Atypical;Absence-Myoclonic absence;Absence-Eyelid myoclonia;Myoclonic;Myoclonic-Myoclonic atonic;Myoclonic-Myoclonic tonic;Clonic;Tonic;Atonic Alphanumeric

Each seizure type needs to be answered using the permissible values for the "Seizure type or subtype present likelihood type" data element. It is possible for a participant/subject to have more than one seizure type. Although individual seizure onsets can appear localized, the location and lateralization are not consistent from one seizure to another. Generalized seizures can be asymmetric.

EPILEPSY: Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, et al. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. http://www.ilae-epilepsy.org/Visitors/Centre/ctf/ctfoverview.cfm Adult;Pediatric Proposed 3.00 2013-08-28 16:08:00.453 Classification of Seizures Assessments and Examinations Physical Examinations

Single Pre-Defined Value Selected

DeBaun Forms
C14130 Seizure focal classification type SeizFocClassTyp The type of focal epileptic seizures, considered to originate within networks limited to one hemisphere, which may be discretely localized or more widely distributed, and may originate in subcortical structures, experience by the participant/subject. The type of focal epileptic seizures, considered to originate within networks limited to one hemisphere, which may be discretely localized or more widely distributed, and may originate in subcortical structures, experience by the participant/subject. Focal Seizure Subtypes Without impairment of consciousness or responsiveness;With observable motor or autonomic components;Involving subjective sensory or psychic phenomena only;With impairment of consciousness or responsiveness;Evolving to a bilateral, convulsive seizure Without impairment of consciousness or responsiveness;Without impairment of consciousness or responsiveness-With observable motor or autonomic components (roughly corresponds to the concept of "simple partial seizure");Without impairment of consciousness or responsiveness-Involving subjective sensory or psychic phenomena only (corresponds to the concept of "aura");With impairment of consciousness or responsiveness (roughly corresponds to the concept of "complex partial seizure");Evolving to a bilateral, convulsive seizure (involving tonic, clonic, or tonic and clonic components replaces the term "secondarily generalized seizure") Alphanumeric

Each seizure type needs to be answered using the permissible values for the "Seizure type or subtype present likelihood type" data element. It is possible for a participant/subject to have more than one seizure type. For each seizure type, ictal onset is consistent from one seizure to another with preferential propagation patterns, which can involve the contralateral hemisphere. In some cases, however, there is more than one epileptogenic network, and more than one seizure type, but each individual seizure type has a consistent site of onset. Focal seizures do not fall into any recognized set of natural classes based on any current understanding of the mechanisms involved.

EPILEPSY: Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, et al. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. http://www.ilae-epilepsy.org/Visitors/Centre/ctf/ctfoverview.cfm Adult;Pediatric Proposed 3.00 2013-08-28 16:08:00.453 Classification of Seizures Assessments and Examinations Physical Examinations

Multiple Pre-Defined Values Selected

C14132 Seizures multiple confidence level distinct type SeizMultConfLvlDistinctTyp Confidence level that two or more seizure types recorded as present are distinct seizure types Confidence level that two or more seizure types recorded as present are distinct seizure types If two or more seizure types were selected as present, rate the confidence level that these are distinct seizure types No confidence;Possible;Probable;Definite;Unknown;N/A Not present;The summary of evidence suggests less than 50% confidence level;The summary of evidence suggests greater than 50% confidence level;The summary of evidence suggests 100% confidence level;The summary of evidence is not sufficient to support a finding;Not Applicable: to be used at the discretion of the Principal Investigator based on study design Alphanumeric

If two or more seizure types were selected as present, rate the confidence level that these are distinct seizure types

EPILEPSY: Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, et al. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. http://www.ilae-epilepsy.org/Visitors/Centre/ctf/ctfoverview.cfm Adult;Pediatric Proposed 3.00 2013-08-28 16:08:00.453 Classification of Seizures Assessments and Examinations Physical Examinations

Single Pre-Defined Value Selected

C14134 Data valid through date and time DataValidThroughDateTime Date (and time, if applicable and known) the data collected are valid through Date the data collected are valid through Information complete up to 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.).

Adult;Pediatric Proposed 3.00 2013-08-28 16:08:00.453 Classification of Seizures Assessments and Examinations Physical Examinations

Free-Form Entry

8 results.
CSV