Date of onset of symptoms
Item
1. Date of onset of symptoms
date
Time of onset of symptoms
Item
1. Time of onset of symptoms
time
Date of of symptom resolution
Item
2. Date of of symptom resolution
date
Time of of symptom resolution
Item
2. Time of of symptom resolution
date
CL Item
Non-fatal stroke (44)
CL Item
Fatal stroke (45)
Symptoms Motor and/or sensory loss
Item
4. Symptoms: [B01] Motor and/or sensory loss in face,arm,leg
boolean
Symptoms Dysphasia/aphasia
Item
4. Symptoms: [B02] Dysphasia/aphasia (difficulty with language)
boolean
Symptoms Dysarthria/dysphagia
Item
4. Symptoms: [B03] Dysarthria/dysphagia (difficulty with speech and swallowing)
boolean
Symptoms Hemianopsia
Item
4. Symptoms: [B04] Hemianopsia
boolean
Symptoms Dizziness/vertigo
Item
4. Symptoms: [B05] Dizziness/vertigo
boolean
Symptoms Ataxia
Item
4. Symptoms: [B06] Ataxia
boolean
Symptoms Nystagmus
Item
4. Symptoms: [B07] Nystagmus
boolean
Symptoms Diplopia
Item
4. Symptoms: [B08] Diplopia
boolean
Symptoms Acute confusion/cognitive change
Item
4. Symptoms: [B09] Acute confusion/cognitive change
boolean
Symptoms Decreased consciousness
Item
4. Symptoms: [B10] Decreased consciousness
boolean
new focal neurologic deficit
Item
5. Did the subject have a new focal neurologic deficit thought to be of vascular origin, with signs or symptoms lasting >24 hours?
boolean
new brain infarct
Item
5. If neurologic symptoms <24 hours, was new brain lesion confirmed by diffusion-weighted MRI showing the presence of a new brain infarct?
boolean
Item
6. Did neuro-imaging show an ischemic defect matching the clinical symptoms?
text
Code List
6. Did neuro-imaging show an ischemic defect matching the clinical symptoms?
Method of diagnosis Neurological exam
Item
7. Method of diagnosis: [B11] Neurological exam
boolean
Method of diagnosis Neuro-ophthalmologic exam
Item
7. Method of diagnosis: [B12] Neuro-ophthalmologic exam (retinal embolism, infarction)
boolean
Method of diagnosis CT scan
Item
7. Method of diagnosis: [B13] CT scan
boolean
Method of diagnosis MRI scan
Item
7. Method of diagnosis: [B14] MRI scan
boolean
Method of diagnosis Invasive angiography
Item
7. Method of diagnosis: [B15] Invasive angiography
boolean
Method of diagnosis Autopsy
Item
7. Method of diagnosis: [B16] Autopsy
boolean
Method of diagnosis Other
Item
7. Method of diagnosis: [OT] Other
boolean
Item
8. Was there a change in the modified Rankin Scale grade?
text
Code List
8. Was there a change in the modified Rankin Scale grade?
CL Item
Not available (NV)
Most recent pre-event modified Rankin Scale grade
Item
8. Most recent pre-event modified Rankin Scale grade
integer
Date of most recent pre-event modified Rankin Scale grade
Item
8. Date of most recent pre-event modified Rankin Scale grade
date
Latest post-event modified Rankin Scale grade
Item
8. Latest post-event modified Rankin Scale grade
integer
Date of latest post-event modified Rankin Scale grade
Item
8. Date of latest post-event modified Rankin Scale grade
date
Item
9. Type of stroke
text
Code List
9. Type of stroke
CL Item
Cerebral infarction with blood felt to represent hemorrhagic conversion and not a primary hemorrhage (79)
CL Item
Type uncertain (8)
CL Item
Not applicable (NP)
narrative
Item
10. Provide narrative
text
Date documents sent to CEC Document Group
Item
11. Date documents sent to CEC Document Group
date
Item
8. Adjudication
text
Code List
8. Adjudication
CL Item
Does not meet criteria for stroke (NC)
CL Item
Non-fatal stroke (44)
CL Item
Fatal stroke (45)
Item
If non-fatal stroke, select one
integer
Code List
If non-fatal stroke, select one
CL Item
Cerebral infarction with blood felt to represent hemorrhagic conversion and not a primary hemorrhage (79)
CL Item
Type uncertain (8)
Non-fatal stroke type uncertain
Item
If type of non-fatal stroke uncertain, comment
text
Item
If fatal stroke, select one
integer
Code List
If fatal stroke, select one
CL Item
Cerebral infarction with blood felt to represent hemorrhagic conversion and not a primary hemorrhage (79)
CL Item
Type uncertain (8)
Fatal stroke, type uncertain
Item
If type of fatal stroke uncertain, comment
text
criteria for stroke not met, comment
Item
Does not meet criteria for stroke, comment
text
Item
If criteria for stroke are not met, selet one
text
Code List
If criteria for stroke are not met, selet one
criteria for stroke not met, other
Item
If other, please comment
text
Date of adjudication
Item
15. Date of adjudication
date
Trigger number
Item
16. Trigger number
text
Item
17. CEC Status
integer
CL Item
Coordinator Screen check (2)
CL Item
Ready for review (4)
CL Item
In Phase I review (5)
CL Item
Queried (InForm) (6)
CL Item
Additional documents required (7)
CL Item
In Phase II committee (8)
CL Item
Completed event (11)
CL Item
No event to adjudicate (12)
CL Item
QC Random sample (13)
CL Item
In Translation (14)
Date of status change
Item
18. Date of status change
date
Item
19. Physician review #1: Physician
integer
Code List
19. Physician review #1: Physician
Physician review 1 Date sent to reviewer
Item
19. Physician review #1: Date sent to reviewer
date
Physician review 1 Date received from reviewer
Item
19. Physician review #1: Date received from reviewer
date
Item
19. Physician review #2: Physician
integer
Code List
19. Physician review #2: Physician
Physician review 2 Date sent to reviewer
Item
19. Physician review #2: Date sent to reviewer
date
Physician review 2 Date received from reviewer
Item
19. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
21. CEC Coordinator comments
text
CV event number
Item
22. CV event number
text
Adverse event reference identifier
Item
23. Adverse event reference identifier
text
Adverse event term
Item
24. Adverse event term
text