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