CDE Detailed Report
Disease: content
Subdomain Name: Patient Reported Outcomes
CRF: welcome
Displaying 1 - 6 of 6
Subdomain Name: Patient Reported Outcomes
CRF: welcome
Displaying 1 - 6 of 6
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.). |
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 |
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| 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. |
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 |
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| 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. |
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 |
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| 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. |
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 |
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 |
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| 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 |
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 |
