ID

33910

Beschrijving

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

Trefwoorden

  1. 07-01-19 07-01-19 -
Houder van rechten

GSK group of companies

Geüploaded op

7 januari 2019

DOI

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Licentie

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

Administrative data
Beschrijving

Administrative data

Site
Beschrijving

Site

Datatype

text

Subject
Beschrijving

Subject

Datatype

text

Visit Name
Beschrijving

Visit Name

Datatype

text

Status
Beschrijving

Status

Datatype

text

Document Number
Beschrijving

Document Number

Datatype

text

Stroke / TIA
Beschrijving

Stroke / TIA

AE / SAE Number
Beschrijving

AE / SAE Number

Datatype

integer

Date of Onset
Beschrijving

Date of Onset

Datatype

date

Time of Onset
Beschrijving

Time of Onset

Datatype

time

Was the subject hospitalized for this event?
Beschrijving

Was the subject hospitalized for this event?

Datatype

boolean

If Yes, please record AE / SAE Number
Beschrijving

If Yes, please record AE / SAE Number

Datatype

integer

Date of hospitalization
Beschrijving

Date of hospitalization

Datatype

date

If No, did this event occur during an ongoing hospitalization?
Beschrijving

If No, did this event occur during an ongoing hospitalization?

Datatype

boolean

Did the subject die due to this event?
Beschrijving

if Yes, please record details on the Death form

Datatype

boolean

Do you consider that the event being reported occurred as a direct consequence of any procedure / operation?
Beschrijving

Do you consider that the event being reported occurred as a direct consequence of any procedure / operation?

Datatype

boolean

If Yes, specify procedure / operation:
Beschrijving

If Yes, specify procedure / operation:

Datatype

text

Date of procedure/operation
Beschrijving

Date of procedure/operation

Datatype

date

AE / SAE Number
Beschrijving

AE / SAE Number

Datatype

integer

Neurological Signs / Symptoms
Beschrijving

Neurological Signs / Symptoms

Focal weakness / paralysis (i.e weakness affecting one side of the body)
Beschrijving

Focal weakness / paralysis (i.e weakness affecting one side of the body)

Datatype

boolean

If Yes, please check all that apply
Beschrijving

If Yes, please check all that apply

Datatype

integer

Focal numbness / sensory change (i.e sensory change affecting one side)
Beschrijving

Focal numbness / sensory change (i.e sensory change affecting one side)

Datatype

boolean

If Yes, check all that apply
Beschrijving

If Yes, check all that apply

Datatype

integer

Change in level of consciousness (e.g., coma)
Beschrijving

Change in level of consciousness (e.g., coma)

Datatype

boolean

Dysplasia / Aphasia
Beschrijving

Dysplasia / Aphasia

Datatype

boolean

Hemianopia (loss of half of the field of vision of one or both eyes)
Beschrijving

Hemianopia (loss of half of the field of vision of one or both eyes)

Datatype

boolean

Complete / partial loss of vision of one eye
Beschrijving

Complete / partial loss of vision of one eye

Datatype

boolean

Other neurological sign(s) / symptom(s)
Beschrijving

Other neurological sign(s) / symptom(s)

Datatype

boolean

If Yes, specify
Beschrijving

If Yes, specify

Datatype

text

Neurological Signs / Symptoms Tendencies
Beschrijving

Neurological Signs / Symptoms Tendencies

Did the neurological signs / symptoms have a rapid onset?
Beschrijving

Did the neurological signs / symptoms have a rapid onset?

Datatype

text

Did the neurological signs/symptoms last for >=24 hours?
Beschrijving

Did the neurological signs/symptoms last for >=24 hours?

Datatype

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?
Beschrijving

e.g. tissue plasminogen activator (t-PA)

Datatype

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?
Beschrijving

e.g. intracranial angioplasty

Datatype

boolean

If Yes, specify
Beschrijving

If Yes, specify

Datatype

text

Date of Procedure
Beschrijving

Date of Procedure

Datatype

date

Was there any readily identifiable cause for the clinical representation other that stroke or TIA (transient ishaemic attack)?
Beschrijving

Was there any readily identifiable cause for the clinical representation other that stroke or TIA (transient ishaemic attack)?

Datatype

boolean

If Yes, please specify
Beschrijving

If Yes, please specify

Datatype

text

Did a specialist in neurology or neurosurgery examine the subject?
Beschrijving

Did a specialist in neurology or neurosurgery examine the subject?

Datatype

boolean

If Yes, in the opinion of this specialist, did a stroke occur?
Beschrijving

If Yes, in the opinion of this specialist, did a stroke occur?

Datatype

boolean

Diagnostic Investigations - CT Brain Scan
Beschrijving

Diagnostic Investigations - CT Brain Scan

Was a CT brain scan performed?
Beschrijving

Was a CT brain scan performed?

Datatype

boolean

Date of scan
Beschrijving

If possible, please submit a copy of the report of the imaging studies

Datatype

date

Did this show any evidence of intracerebral haemorrhage?
Beschrijving

Did this show any evidence of intracerebral haemorrhage?

Datatype

boolean

Did this show any evidence of subarachnoid haemorrhage?
Beschrijving

Did this show any evidence of subarachnoid haemorrhage?

Datatype

boolean

Did this show any evidence of infarction?
Beschrijving

Did this show any evidence of infarction?

Datatype

boolean

Did this show any other finding of clinical significance?
Beschrijving

Did this show any other finding of clinical significance?

Datatype

boolean

If Yes, specify
Beschrijving

If Yes, specify

Datatype

text

Diagnostic Investigations - MRI Brain Scan
Beschrijving

Diagnostic Investigations - MRI Brain Scan

Was an MRI brain scan performed?
Beschrijving

If possible, please submit a copy of the report of the imaging studies

Datatype

boolean

If Yes, date of scan
Beschrijving

If Yes, date of scan

Datatype

date

Did this show any evidence of intracerebral haemorrhage?
Beschrijving

Did this show any evidence of intracerebral haemorrhage?

Datatype

boolean

Did this show any evidence of subarachnoid haemorrhage?
Beschrijving

Did this show any evidence of subarachnoid haemorrhage?

Datatype

boolean

Did this show any evidence of infarction?
Beschrijving

Did this show any evidence of infarction?

Datatype

boolean

Did this show any other finding of clinical significance?
Beschrijving

Did this show any other finding of clinical significance?

Datatype

boolean

If Yes, please specify
Beschrijving

If Yes, please specify

Datatype

text

Diagnostic Investigations - Cerebral Angiography
Beschrijving

Diagnostic Investigations - Cerebral Angiography

Was cerebral angiography performed?
Beschrijving

If possible, please submit a copy of the report of the imaging studies

Datatype

boolean

If Yes, date of cerebral angiography
Beschrijving

If Yes, date of cerebral angiography

Datatype

date

Did this show any evidence of aneurysm or arteriovenous malformation?
Beschrijving

any evidence of aneurysm or arteriovenous malformation?

Datatype

boolean

Did this show any significant obstructive disease or occlusion?
Beschrijving

any significant obstructive disease or occlusion?

Datatype

boolean

Did this show any other finding or clinical significance?
Beschrijving

any other finding or clinical significance?

Datatype

boolean

If Yes, specify
Beschrijving

If Yes, specify

Datatype

text

Diagnostic Investigations - Lumbar Puncture
Beschrijving

Diagnostic Investigations - Lumbar Puncture

Was a Lumbar Puncture performed?
Beschrijving

Was a Lumbar Puncture performed?

Datatype

boolean

Date of Lumbar Puncture
Beschrijving

Date of Lumbar Puncture

Datatype

date

Was spinal fluid examination diagnostic of intracranial haemorrhage?
Beschrijving

Was spinal fluid examination diagnostic of intracranial haemorrhage?

Datatype

boolean

Were any other investigation(s) performed that provided evidence to support a diagnosis of stroke / TIA?
Beschrijving

If possible, please submit a copy of the report of the imaging studies

Datatype

boolean

If Yes, please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant finding(s):
Beschrijving

If Yes, please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant finding(s):

Datatype

text

Date of Investigation
Beschrijving

Date of Investigation

Datatype

text

Please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant finding(s):
Beschrijving

Please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant finding(s):

Datatype

text

Date of Investigation
Beschrijving

Date of Investigation

Datatype

date

Final Clinical Diagnosis
Beschrijving

Final Clinical Diagnosis

What was the final clinical diagnosis in relation to this event?
Beschrijving

What was the final clinical diagnosis in relation to this event?

Datatype

text

Specify Other Diagnosis
Beschrijving

Specify Other Diagnosis

Datatype

text

Narrative
Beschrijving

Narrative

Briefly describe the event
Beschrijving

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.

Datatype

text

Was modified Rankin Criteria evaluated at first follow-up visit for subject after stroke?
Beschrijving

Was modified Rankin Criteria evaluated at first follow-up visit for subject after stroke?

Datatype

boolean

Date of first follow-up visit for subject after stroke
Beschrijving

Date of first follow-up visit for subject after stroke

Datatype

date

Outcome of Stroke Event
Beschrijving

Outcome of Stroke Event

Datatype

text

Similar models

Adjudication Events - Stroke / TIA

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Site
Item
Site
text
Subject
Item
Subject
text
Item
Visit Name
text
Code List
Visit Name
CL Item
Adjudication (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
Item Group
Stroke / TIA
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
Item Group
Neurological Signs / Symptoms
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
Item
If Yes, please check all that apply
integer
Code List
If Yes, please check all that apply
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
Item
If Yes, check all that apply
integer
Code List
If Yes, check all that apply
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 Group
Neurological Signs / Symptoms Tendencies
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
Item Group
Diagnostic Investigations - CT Brain Scan
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
Item Group
Diagnostic Investigations - MRI Brain Scan
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
Item Group
Diagnostic Investigations - Lumbar Puncture
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 Group
Final Clinical Diagnosis
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
Item Group
Narrative
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
Item
Outcome of Stroke Event
text
Code List
Outcome of Stroke Event
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)

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