Study Medication Prior To Event
Item
1. Was the patient on study medication within the 7 days prior to the event?
boolean
Item
If NO, indicate which medication the patient was not taking (please indicate all that apply):
integer
C0030705 (UMLS CUI [1,1])
C0457432 (UMLS CUI [1,2])
Code List
If NO, indicate which medication the patient was not taking (please indicate all that apply):
CL Item
Blister card C (3)
CL Item
Blister card D (4)
Date of onset stroke symptoms
Item
2. Date of onset stroke symptoms (dd mon yy)
date
Time of onset stroke symptoms
Item
3. Time of onset stroke symptoms (24 hour clock time-hh:mm)
time
Item
4. Duration of symptoms:
integer
C0449238 (UMLS CUI [1])
Code List
4. Duration of symptoms:
Item
5. Decreased consciousness
integer
Code List
5. Decreased consciousness
Item
6. Headache
integer
C0018681 (UMLS CUI [1])
Item
7. Nausea-Vomiting
integer
C0027498 (UMLS CUI [1])
Code List
7. Nausea-Vomiting
Item
8. Dysphasia
integer
C0973461 (UMLS CUI [1])
Item
9. Neglect
integer
C0422887 (UMLS CUI [1])
Item
10. Dysarthria
integer
C0013362 (UMLS CUI [1])
Item
11. Hemaniopia
integer
C0018979 (UMLS CUI [1])
Item
12. Ataxia
integer
C0004134 (UMLS CUI [1])
Item
13. Diplopia
integer
C0012569 (UMLS CUI [1])
Item
14. Monocular vision loss
integer
Code List
14. Monocular vision loss
Item
15. Vertigo
integer
C0042571 (UMLS CUI [1])
Item
16. Motor Power Face
integer
Code List
16. Motor Power Face
CL Item
Left Abnormal (2)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
Item
17. Motor power arm
integer
Code List
17. Motor power arm
CL Item
Left Abnormal (2)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
Item
18. Motor power leg
integer
Code List
18. Motor power leg
CL Item
Left Abnormal (2)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
Item
19. Sensation Face
integer
Code List
19. Sensation Face
CL Item
Left Abnormal (2)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
Item
20. Sensation arm
integer
Code List
20. Sensation arm
CL Item
Left Abnormal (2)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
Item
21. Sensation leg
integer
Code List
21. Sensation leg
CL Item
Left Abnormal (2)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
Item
22. Location of new stroke
integer
Code List
22. Location of new stroke
CL Item
left hemispheric (1)
CL Item
right hemispheric (2)
Item
23. Please indicate which of the following were done in conjunction with the stroke:
integer
Code List
23. Please indicate which of the following were done in conjunction with the stroke:
CL Item
Magnetic resonance imaging (1)
CL Item
Computerized Tomography (2)
CL Item
Diffusion weighted imaging (3)
CL Item
Perfusion imaging (4)
CL Item
Doppler/Duplex (6)
CL Item
Treated with Thrombolytics (7)
CL Item
Treated with surgery (8)
Specification
Item
Specify other:
text
C2348235 (UMLS CUI [1])
new stroke confirmed by brain imaging
Item
boolean
Item
1. Please indicate stroke type
integer
C3897486 (UMLS CUI [1])
Code List
1. Please indicate stroke type
CL Item
Ischemic (infarction) (1)
CL Item
Subarachnoid hemorrhage (2)
CL Item
Intracerebral hemorrhage (3)
CL Item
Uncertain type (4)
Ischemic infarction
Item
Was new stroke confined to a central retinal arterial occlusion?
boolean
Item
2. For ischemic stroke, please categories the etiologic subtype below (indicate one only)
integer
C0038454 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Code List
2. For ischemic stroke, please categories the etiologic subtype below (indicate one only)
CL Item
Large-artery atherosclerosis (1)
CL Item
Cardioembolism (2)
CL Item
Small-artery occlusion (lacune) (3)
CL Item
Acute stroke of other determined etiology (4)
CL Item
Stroke of underdetermined etiology (5)
Item
3. Please fill in the Modified Rankin Scale below. (indicate only one) ->Please keep patient on trial medication if possible. It is strongly recommended to continue the treatment until the end of the trial period despite the occurrence of a non-fatal stroke.
integer
C2984908 (UMLS CUI [1])
Code List
3. Please fill in the Modified Rankin Scale below. (indicate only one) ->Please keep patient on trial medication if possible. It is strongly recommended to continue the treatment until the end of the trial period despite the occurrence of a non-fatal stroke.
CL Item
Grade 6 (fatal) (7)
Fatal Event
Item
5. Was the event fatal (death within 28 days)? If yes please complete Death Report Form.
boolean
Item
6. Please indicate which supporting documentation has been supplied:
integer
Code List
6. Please indicate which supporting documentation has been supplied:
CL Item
Brain Imaging (1)
CL Item
Vascular Imaging (2)
CL Item
Cardiac Evaluation (3)
CL Item
Other supporting testing (4)
Invenstigator´s Declaration
Item
8. Invenstigator´s Declaration By signing and dating this page, I declare that I have reviewed for accuracy all case report form pages for this patient; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed in the dates specified.
text
Investigator´s signature
Item
Investigator´s signature
text
C2346576 (UMLS CUI [1])
Date of Signature
Item
Date of Signature
date
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])