ID
33910
Description
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
Mots-clés
Versions (1)
- 07/01/2019 07/01/2019 -
Détendeur de droits
GSK group of companies
Téléchargé le
7 janvier 2019
DOI
Pour une demande vous connecter.
Licence
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
Description
Stroke / TIA
Description
AE / SAE Number
Type de données
integer
Description
Date of Onset
Type de données
date
Description
Time of Onset
Type de données
time
Description
Was the subject hospitalized for this event?
Type de données
boolean
Description
If Yes, please record AE / SAE Number
Type de données
integer
Description
Date of hospitalization
Type de données
date
Description
If No, did this event occur during an ongoing hospitalization?
Type de données
boolean
Description
if Yes, please record details on the Death form
Type de données
boolean
Description
Do you consider that the event being reported occurred as a direct consequence of any procedure / operation?
Type de données
boolean
Description
If Yes, specify procedure / operation:
Type de données
text
Description
Date of procedure/operation
Type de données
date
Description
AE / SAE Number
Type de données
integer
Description
Neurological Signs / Symptoms
Description
Focal weakness / paralysis (i.e weakness affecting one side of the body)
Type de données
boolean
Description
If Yes, please check all that apply
Type de données
integer
Description
Focal numbness / sensory change (i.e sensory change affecting one side)
Type de données
boolean
Description
If Yes, check all that apply
Type de données
integer
Description
Change in level of consciousness (e.g., coma)
Type de données
boolean
Description
Dysplasia / Aphasia
Type de données
boolean
Description
Hemianopia (loss of half of the field of vision of one or both eyes)
Type de données
boolean
Description
Complete / partial loss of vision of one eye
Type de données
boolean
Description
Other neurological sign(s) / symptom(s)
Type de données
boolean
Description
If Yes, specify
Type de données
text
Description
Neurological Signs / Symptoms Tendencies
Description
Did the neurological signs / symptoms have a rapid onset?
Type de données
text
Description
Did the neurological signs/symptoms last for >=24 hours?
Type de données
boolean
Description
e.g. tissue plasminogen activator (t-PA)
Type de données
boolean
Description
e.g. intracranial angioplasty
Type de données
boolean
Description
If Yes, specify
Type de données
text
Description
Date of Procedure
Type de données
date
Description
Was there any readily identifiable cause for the clinical representation other that stroke or TIA (transient ishaemic attack)?
Type de données
boolean
Description
If Yes, please specify
Type de données
text
Description
Did a specialist in neurology or neurosurgery examine the subject?
Type de données
boolean
Description
If Yes, in the opinion of this specialist, did a stroke occur?
Type de données
boolean
Description
Diagnostic Investigations - CT Brain Scan
Description
Was a CT brain scan performed?
Type de données
boolean
Description
If possible, please submit a copy of the report of the imaging studies
Type de données
date
Description
Did this show any evidence of intracerebral haemorrhage?
Type de données
boolean
Description
Did this show any evidence of subarachnoid haemorrhage?
Type de données
boolean
Description
Did this show any evidence of infarction?
Type de données
boolean
Description
Did this show any other finding of clinical significance?
Type de données
boolean
Description
If Yes, specify
Type de données
text
Description
Diagnostic Investigations - MRI Brain Scan
Description
If possible, please submit a copy of the report of the imaging studies
Type de données
boolean
Description
If Yes, date of scan
Type de données
date
Description
Did this show any evidence of intracerebral haemorrhage?
Type de données
boolean
Description
Did this show any evidence of subarachnoid haemorrhage?
Type de données
boolean
Description
Did this show any evidence of infarction?
Type de données
boolean
Description
Did this show any other finding of clinical significance?
Type de données
boolean
Description
If Yes, please specify
Type de données
text
Description
Diagnostic Investigations - Cerebral Angiography
Description
If possible, please submit a copy of the report of the imaging studies
Type de données
boolean
Description
If Yes, date of cerebral angiography
Type de données
date
Description
any evidence of aneurysm or arteriovenous malformation?
Type de données
boolean
Description
any significant obstructive disease or occlusion?
Type de données
boolean
Description
any other finding or clinical significance?
Type de données
boolean
Description
If Yes, specify
Type de données
text
Description
Diagnostic Investigations - Lumbar Puncture
Description
Was a Lumbar Puncture performed?
Type de données
boolean
Description
Date of Lumbar Puncture
Type de données
date
Description
Was spinal fluid examination diagnostic of intracranial haemorrhage?
Type de données
boolean
Description
If possible, please submit a copy of the report of the imaging studies
Type de données
boolean
Description
If Yes, please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant finding(s):
Type de données
text
Description
Date of Investigation
Type de données
text
Description
Please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant finding(s):
Type de données
text
Description
Date of Investigation
Type de données
date
Description
Final Clinical Diagnosis
Description
Narrative
Description
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.
Type de données
text
Description
Was modified Rankin Criteria evaluated at first follow-up visit for subject after stroke?
Type de données
boolean
Description
Date of first follow-up visit for subject after stroke
Type de données
date
Description
Outcome of Stroke Event
Type de données
text
Similar models
Adjudication Events - Stroke / TIA
- StudyEvent: ODM