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CDE ID | CDE Name | Variable Name | Definition / Description | Question Text | Permissible Value | Description | Data Type | Instructions | References | Population | Classification (e.g., Core) | Version # | Version Date | Aliases for Variable Name | CRF Module / Guideline | © or TM | Sub-Domain | Domain | Previous Title | Size | Input Restrictions | Min Value | Max Value | Measurement Type | LOINC ID | SNOMED | caDSR ID | CDISC ID |
C10626 | Condition diary date and time | CondDiaryDateTime | Date (and time, if applicable and known) the diary data are recorded | Date | | | 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.).
Supplemental - Highly Recommended | No references available | Adult;Pediatric | Supplemental–Highly Recommended | 3.0 | 8/28/2013 | Aliases for variable name not defined | Seizure Diary | | Patient Reported Outcomes | Outcomes and End Points | Diary date and time | | Free-Form Entry | | | | | | | |
C14136 | Seizure daily diary no seizure indicator | SeizDlyDiaryNoSeizInd | The indicator of whether the participant/subject experienced NO seizures on the corresponding date | No Seizures | No seizures; | No seizures; | Alphanumeric | Mark the no seizure box if you did not have any seizures for a day.
Supplemental - Highly Recommended | No references available | Adult;Pediatric | Supplemental–Highly Recommended | 3.0 | 8/28/2013 | Aliases for variable name not defined | Seizure Diary | | Patient Reported Outcomes | Outcomes and End Points | Diary day seizure indicator | | Single Pre-Defined Value Selected | | | | | | | |
C10635 | Seizure daily diary seizure type | SeizDlyDiarySeizTyp | Type of seizure experienced by the participant/subject on the specific date | Seizure code | Generalized Tonic Clonic (in any combination);Generalized Absence;Generalized Absence-Typical;Generalized Absence-Atypical;Generalized Absence-Myoclonic absence;Generalized Absence-Eyelid myoclonia;Generalized Myoclonic;Generalized Myoclonic-Myoclonic atonic;Generalized Myoclonic-Myoclonic tonic;Generalized Clonic;Generalized Tonic;Generalized Atonic;Epileptic spasms, focal or generalized;Focal without impairment of consciousness or responsiveness;Focal without impairment of consciousness or responsiveness -With observable motor or autonomic components (roughly corresponds to the concept of “simple partial seizure”);Focal without impairment of consciousness or responsiveness- Involving subjective sensory or psychic phenomena only (corresponds to the concept of “aura”);Focal with impairment of consciousness or responsiveness (roughly corresponds to the concept of “complex partial seizure”);Focal evolving to a bilateral, convulsive seizure (involving tonic, clonic, or tonic and clonic components - replaces the term “secondarily generalized seizure”);Unclassified seizure type; | Generalized Tonic Clonic (in any combination);Generalized Absence;Generalized Absence-Typical;Generalized Absence-Atypical;Generalized Absence-Myoclonic absence;Generalized Absence-Eyelid myoclonia;Generalized Myoclonic;Generalized Myoclonic-Myoclonic atonic;Generalized Myoclonic-Myoclonic tonic;Generalized Clonic;Generalized Tonic;Generalized Atonic;Epileptic spasms, focal or generalized;Focal without impairment of consciousness or responsiveness;Focal without impairment of consciousness or responsiveness -With observable motor or autonomic components (roughly corresponds to the concept of “simple partial seizure”);Focal without impairment of consciousness or responsiveness- Involving subjective sensory or psychic phenomena only (corresponds to the concept of “aura”);Focal with impairment of consciousness or responsiveness (roughly corresponds to the concept of “complex partial seizure”);Focal evolving to a bilateral, convulsive seizure (involving tonic, clonic, or tonic and clonic components - replaces the term “secondarily generalized seizure”);Unclassified seizure type; | Alphanumeric | Record the number of seizures and the type of seizure (using the assigned code) on the diary. The physician/coordinator will review the diary with the patient and ask them to describe each of his/her seizures. Each seizure type will then be classified using the standard seizure terminology and be assigned a single code (A - F) for use on the diary.
Supplemental - Highly Recommended | No references available | Adult;Pediatric | Supplemental–Highly Recommended | 3.0 | 8/28/2013 | Aliases for variable name not defined | Seizure Diary | | Patient Reported Outcomes | Outcomes and End Points | Diary day seizure type | | Single Pre-Defined Value Selected | | | | | | | |
C14138 | Seizure daily diary seizure type count | SeizDlyDiarySeizTypCt | The number of seizures of the particular seizure type that the participant/subject experienced on the corresponding date | | | | Numeric Values | Indicate number of seizures for each type of seizure identified.
Supplemental - Highly Recommended | No references available | Adult;Pediatric | Supplemental–Highly Recommended | 3.0 | 8/28/2013 | Aliases for variable name not defined | Seizure Diary | | Patient Reported Outcomes | Outcomes and End Points | Diary day seizure type count | | Free-Form Entry | 0 | 99 | | | | | |
C14139 | Seizure diary completer type | SeizDiaryCompltrTyp | The type of person recording the diary data | Who is completing the seizure diary? | Participant/subject;Caregiver;Other, specify; | Participant/subject;Caregiver;Other, specify; | Alphanumeric | Choose only one
Supplemental - Highly Recommended | No references available | Adult;Pediatric | Supplemental–Highly Recommended | 3.0 | 8/28/2013 | Aliases for variable name not defined | Seizure Diary | | Patient Reported Outcomes | Outcomes and End Points | Diary reporter type | | Single Pre-Defined Value Selected | | | | | | | |
C18904 | Seizure diary completer other text | SeizDiaryCompltrOTH | The free-text field related to 'Seizure diary completer type' specifying other text. The type of person recording the diary data | Other, specify | | | Alphanumeric | Choose only one
Supplemental - Highly Recommended | No references available | Adult;Pediatric | Supplemental | 3.0 | 8/28/2013 | Aliases for variable name not defined | Seizure Diary | | Patient Reported Outcomes | Outcomes and End Points | | 4000 | Free-Form Entry | | | | | | | |