CDE Detailed Report

Disease: content
Sub-Domain: Patient Reported Outcomes
CRF: welcome

Displaying 1 - 6 of 6
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
C10626 Condition diary date and time CondDiaryDateTime Date (and time, if applicable and known) the diary data are recorded 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 3.00 2013-08-28 16:08:00.453 Seizure Diary Patient Reported Outcomes Outcomes and End Points

Free-Form Entry

C10635 Seizure daily diary seizure type SeizDlyDiarySeizTyp Type of seizure experienced by the participant/subject on the specific date The type of seizure experienced by the participant/subject on the corresponding 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 3.00 2013-08-28 16:08:00.453 Seizure Diary Patient Reported Outcomes Outcomes and End Points

Single Pre-Defined Value Selected

C14136 Seizure daily diary no seizure indicator SeizDlyDiaryNoSeizInd The indicator of whether the participant/subject experienced NO seizures on the corresponding date 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 3.00 2013-08-28 16:08:00.453 Seizure Diary Patient Reported Outcomes Outcomes and End Points

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 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 3.00 2013-08-28 16:08:00.453 Seizure Diary Patient Reported Outcomes Outcomes and End Points

Free-Form Entry

0 99
C14139 Seizure diary completer type SeizDiaryCompltrTyp The type of person recording the diary data The person completing the diary 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 3.00 2013-08-28 16:08:00.453 Seizure Diary Patient Reported Outcomes Outcomes and End Points

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 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 3.00 2013-08-28 16:08:00.453 Seizure Diary Patient Reported Outcomes Outcomes and End Points 4000

Free-Form Entry

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