Stroke / TIA
AE / SAE Number
integer
Date of Onset
date
Time of Onset
time
Was the subject hospitalized for this event?
boolean
If Yes, please record AE / SAE Number
integer
Date of hospitalization
date
If No, did this event occur during an ongoing hospitalization?
boolean
if Yes, please record details on the Death form
boolean
Do you consider that the event being reported occurred as a direct consequence of any procedure / operation?
boolean
If Yes, specify procedure / operation:
text
Date of procedure/operation
date
AE / SAE Number
integer
Neurological Signs / Symptoms
Focal weakness / paralysis (i.e weakness affecting one side of the body)
boolean
If Yes, please check all that apply
integer
Focal numbness / sensory change (i.e sensory change affecting one side)
boolean
If Yes, check all that apply
integer
Change in level of consciousness (e.g., coma)
boolean
Dysplasia / Aphasia
boolean
Hemianopia (loss of half of the field of vision of one or both eyes)
boolean
Complete / partial loss of vision of one eye
boolean
Other neurological sign(s) / symptom(s)
boolean
If Yes, specify
text
Neurological Signs / Symptoms Tendencies
Did the neurological signs / symptoms have a rapid onset?
text
Did the neurological signs/symptoms last for >=24 hours?
boolean
e.g. tissue plasminogen activator (t-PA)
boolean
e.g. intracranial angioplasty
boolean
If Yes, specify
text
Date of Procedure
date
Was there any readily identifiable cause for the clinical representation other that stroke or TIA (transient ishaemic attack)?
boolean
If Yes, please specify
text
Did a specialist in neurology or neurosurgery examine the subject?
boolean
If Yes, in the opinion of this specialist, did a stroke occur?
boolean
Diagnostic Investigations - CT Brain Scan
Was a CT brain scan performed?
boolean
If possible, please submit a copy of the report of the imaging studies
date
Did this show any evidence of intracerebral haemorrhage?
boolean
Did this show any evidence of subarachnoid haemorrhage?
boolean
Did this show any evidence of infarction?
boolean
Did this show any other finding of clinical significance?
boolean
If Yes, specify
text
Diagnostic Investigations - MRI Brain Scan
If possible, please submit a copy of the report of the imaging studies
boolean
If Yes, date of scan
date
Did this show any evidence of intracerebral haemorrhage?
boolean
Did this show any evidence of subarachnoid haemorrhage?
boolean
Did this show any evidence of infarction?
boolean
Did this show any other finding of clinical significance?
boolean
If Yes, please specify
text
Diagnostic Investigations - Cerebral Angiography
If possible, please submit a copy of the report of the imaging studies
boolean
If Yes, date of cerebral angiography
date
any evidence of aneurysm or arteriovenous malformation?
boolean
any significant obstructive disease or occlusion?
boolean
any other finding or clinical significance?
boolean
If Yes, specify
text
Diagnostic Investigations - Lumbar Puncture
Was a Lumbar Puncture performed?
boolean
Date of Lumbar Puncture
date
Was spinal fluid examination diagnostic of intracranial haemorrhage?
boolean
If possible, please submit a copy of the report of the imaging studies
boolean
If Yes, please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant finding(s):
text
Date of Investigation
text
Please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant finding(s):
text
Date of Investigation
date
Final Clinical Diagnosis
Narrative
Please include clinical presentation, duration of events, therapy for the events, results of relevant investigations (e.g. CT brain scan) and/or neurology consultation and outcome, including autopsy if appropriate. Please provide sufficient information to allow the Endpoint Committee to accurately classify this event.
text
Was modified Rankin Criteria evaluated at first follow-up visit for subject after stroke?
boolean
Date of first follow-up visit for subject after stroke
date
Outcome of Stroke Event
text