Information:
Fel:
ID
33910
Beskrivning
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2
Nyckelord
Versioner (1)
- 2019-01-07 2019-01-07 -
Rättsinnehavare
GSK group of companies
Uppladdad den
7 januari 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Adjudication Events - Stroke / TIA
- StudyEvent: ODM
Similar models
Adjudication Events - Stroke / TIA
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Site
Item
Site
text
Subject
Item
Subject
text
CL Item
Adjudication (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
AE / SAE Number
Item
AE / SAE Number
integer
Date of Onset
Item
Date of Onset
date
Time of Onset
Item
Time of Onset
time
Was the subject hospitalized for this event?
Item
Was the subject hospitalized for this event?
boolean
If Yes, please record AE / SAE Number
Item
If Yes, please record AE / SAE Number
integer
Date of hospitalization
Item
Date of hospitalization
date
If No, did this event occur during an ongoing hospitalization?
Item
If No, did this event occur during an ongoing hospitalization?
boolean
Did the subject die due to this event?
Item
Did the subject die due to this event?
boolean
Do you consider that the event being reported occurred as a direct consequence of any procedure / operation?
Item
Do you consider that the event being reported occurred as a direct consequence of any procedure / operation?
boolean
If Yes, specify procedure / operation:
Item
If Yes, specify procedure / operation:
text
Date of procedure/operation
Item
Date of procedure/operation
date
AE / SAE Number
Item
AE / SAE Number
integer
Focal weakness / paralysis (i.e weakness affecting one side of the body)
Item
Focal weakness / paralysis (i.e weakness affecting one side of the body)
boolean
CL Item
arm / hand (1)
CL Item
face (2)
CL Item
lower extremity (3)
Focal numbness / sensory change (i.e sensory change affecting one side)
Item
Focal numbness / sensory change (i.e sensory change affecting one side)
boolean
CL Item
arm / hand (1)
CL Item
face (2)
CL Item
lower extremity (3)
Change in level of consciousness (e.g., coma)
Item
Change in level of consciousness (e.g., coma)
boolean
Dysplasia / Aphasia
Item
Dysplasia / Aphasia
boolean
Hemianopia (loss of half of the field of vision of one or both eyes)
Item
Hemianopia (loss of half of the field of vision of one or both eyes)
boolean
Complete / partial loss of vision of one eye
Item
Complete / partial loss of vision of one eye
boolean
Other neurological sign(s) / symptom(s)
Item
Other neurological sign(s) / symptom(s)
boolean
If Yes, specify
Item
If Yes, specify
text
Item
Did the neurological signs / symptoms have a rapid onset?
text
Code List
Did the neurological signs / symptoms have a rapid onset?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Did the neurological signs/symptoms last for >=24 hours?
Item
Did the neurological signs/symptoms last for >=24 hours?
boolean
If No, was the fact that the neurological signs/symptoms lasted <24 hours believed to be the consequence of therapy with a thrombolytic agent?
Item
If No, was the fact that the neurological signs/symptoms lasted <24 hours believed to be the consequence of therapy with a thrombolytic agent?
boolean
If No, was the fact that the neurological sign/symptoms lasted <24 hours believed to be the consequence of therapy with a neurointerventional procedure?
Item
If No, was the fact that the neurological sign/symptoms lasted <24 hours believed to be the consequence of therapy with a neurointerventional procedure?
boolean
If Yes, specify
Item
If Yes, specify
text
Date of Procedure
Item
Date of Procedure
date
Was there any readily identifiable cause for the clinical representation other that stroke or TIA (transient ishaemic attack)?
Item
Was there any readily identifiable cause for the clinical representation other that stroke or TIA (transient ishaemic attack)?
boolean
If Yes, please specify
Item
If Yes, please specify
text
Did a specialist in neurology or neurosurgery examine the subject?
Item
Did a specialist in neurology or neurosurgery examine the subject?
boolean
If Yes, in the opinion of this specialist, did a stroke occur?
Item
If Yes, in the opinion of this specialist, did a stroke occur?
boolean
Was a CT brain scan performed?
Item
Was a CT brain scan performed?
boolean
Date of scan
Item
Date of scan
date
Did this show any evidence of intracerebral haemorrhage?
Item
Did this show any evidence of intracerebral haemorrhage?
boolean
Did this show any evidence of subarachnoid haemorrhage?
Item
Did this show any evidence of subarachnoid haemorrhage?
boolean
Did this show any evidence of infarction?
Item
Did this show any evidence of infarction?
boolean
Did this show any other finding of clinical significance?
Item
Did this show any other finding of clinical significance?
boolean
If Yes, specify
Item
If Yes, specify
text
Was an MRI brain scan performed?
Item
Was an MRI brain scan performed?
boolean
If Yes, date of scan
Item
If Yes, date of scan
date
Did this show any evidence of intracerebral haemorrhage?
Item
Did this show any evidence of intracerebral haemorrhage?
boolean
Did this show any evidence of subarachnoid haemorrhage?
Item
Did this show any evidence of subarachnoid haemorrhage?
boolean
Did this show any evidence of infarction?
Item
Did this show any evidence of infarction?
boolean
Did this show any other finding of clinical significance?
Item
Did this show any other finding of clinical significance?
boolean
If Yes, please specify
Item
If Yes, please specify
text
Item Group
Diagnostic Investigations - Cerebral Angiography
Was cerebral angiography performed?
Item
Was cerebral angiography performed?
boolean
If Yes, date of cerebral angiography
Item
If Yes, date of cerebral angiography
date
any evidence of aneurysm or arteriovenous malformation?
Item
Did this show any evidence of aneurysm or arteriovenous malformation?
boolean
any significant obstructive disease or occlusion?
Item
Did this show any significant obstructive disease or occlusion?
boolean
any other finding or clinical significance?
Item
Did this show any other finding or clinical significance?
boolean
If Yes, specify
Item
If Yes, specify
text
Was a Lumbar Puncture performed?
Item
Was a Lumbar Puncture performed?
boolean
Date of Lumbar Puncture
Item
Date of Lumbar Puncture
date
Was spinal fluid examination diagnostic of intracranial haemorrhage?
Item
Was spinal fluid examination diagnostic of intracranial haemorrhage?
boolean
Were any other investigation(s) performed that provided evidence to support a diagnosis of stroke / TIA?
Item
Were any other investigation(s) performed that provided evidence to support a diagnosis of stroke / TIA?
boolean
If Yes, please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant finding(s):
Item
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
Item
Date of Investigation
text
Please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant finding(s):
Item
Please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant finding(s):
text
Date of Investigation
Item
Date of Investigation
date
Item
What was the final clinical diagnosis in relation to this event?
text
Code List
What was the final clinical diagnosis in relation to this event?
CL Item
Intracerebral haemorrhage (1)
CL Item
Subarachnoid haemorrhage (2)
CL Item
Non-haemorrhagic stroke(i.e no haemorrhage apparent) (3)
CL Item
Type of stroke unknown (e.g. haemorrhagic or non-haemorrhage) (4)
CL Item
TIA (5)
CL Item
Other diagnosis (6)
Specify Other Diagnosis
Item
Specify Other Diagnosis
text
Description of Event
Item
Briefly describe the event
text
Was modified Rankin Criteria evaluated at first follow-up visit for subject after stroke?
Item
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
Item
Date of first follow-up visit for subject after stroke
date
CL Item
Mild: no significant disability symptoms: able to carry out all usual duties and activities; or slight disability; unable to carry out all previous activities, but to look after own affairs without assistance. (1)
CL Item
Moderate: moderate disability requiring some help but able to walk without assistance; or moderately severe disability such as unable to walk without assistance and unable to attend to own bodily needs without assistance (2)
CL Item
Severe disability: bedridden, incontinent, and requiring constant nursing care and attention; or death (3)