ID
33910
Beschreibung
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
Stichworte
Versionen (1)
- 07.01.19 07.01.19 -
Rechteinhaber
GSK group of companies
Hochgeladen am
7. Januar 2019
DOI
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Lizenz
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
Beschreibung
Stroke / TIA
Beschreibung
AE / SAE Number
Datentyp
integer
Beschreibung
Date of Onset
Datentyp
date
Beschreibung
Time of Onset
Datentyp
time
Beschreibung
Was the subject hospitalized for this event?
Datentyp
boolean
Beschreibung
If Yes, please record AE / SAE Number
Datentyp
integer
Beschreibung
Date of hospitalization
Datentyp
date
Beschreibung
If No, did this event occur during an ongoing hospitalization?
Datentyp
boolean
Beschreibung
if Yes, please record details on the Death form
Datentyp
boolean
Beschreibung
Do you consider that the event being reported occurred as a direct consequence of any procedure / operation?
Datentyp
boolean
Beschreibung
If Yes, specify procedure / operation:
Datentyp
text
Beschreibung
Date of procedure/operation
Datentyp
date
Beschreibung
AE / SAE Number
Datentyp
integer
Beschreibung
Neurological Signs / Symptoms
Beschreibung
Focal weakness / paralysis (i.e weakness affecting one side of the body)
Datentyp
boolean
Beschreibung
If Yes, please check all that apply
Datentyp
integer
Beschreibung
Focal numbness / sensory change (i.e sensory change affecting one side)
Datentyp
boolean
Beschreibung
If Yes, check all that apply
Datentyp
integer
Beschreibung
Change in level of consciousness (e.g., coma)
Datentyp
boolean
Beschreibung
Dysplasia / Aphasia
Datentyp
boolean
Beschreibung
Hemianopia (loss of half of the field of vision of one or both eyes)
Datentyp
boolean
Beschreibung
Complete / partial loss of vision of one eye
Datentyp
boolean
Beschreibung
Other neurological sign(s) / symptom(s)
Datentyp
boolean
Beschreibung
If Yes, specify
Datentyp
text
Beschreibung
Neurological Signs / Symptoms Tendencies
Beschreibung
Did the neurological signs / symptoms have a rapid onset?
Datentyp
text
Beschreibung
Did the neurological signs/symptoms last for >=24 hours?
Datentyp
boolean
Beschreibung
e.g. tissue plasminogen activator (t-PA)
Datentyp
boolean
Beschreibung
e.g. intracranial angioplasty
Datentyp
boolean
Beschreibung
If Yes, specify
Datentyp
text
Beschreibung
Date of Procedure
Datentyp
date
Beschreibung
Was there any readily identifiable cause for the clinical representation other that stroke or TIA (transient ishaemic attack)?
Datentyp
boolean
Beschreibung
If Yes, please specify
Datentyp
text
Beschreibung
Did a specialist in neurology or neurosurgery examine the subject?
Datentyp
boolean
Beschreibung
If Yes, in the opinion of this specialist, did a stroke occur?
Datentyp
boolean
Beschreibung
Diagnostic Investigations - CT Brain Scan
Beschreibung
Was a CT brain scan performed?
Datentyp
boolean
Beschreibung
If possible, please submit a copy of the report of the imaging studies
Datentyp
date
Beschreibung
Did this show any evidence of intracerebral haemorrhage?
Datentyp
boolean
Beschreibung
Did this show any evidence of subarachnoid haemorrhage?
Datentyp
boolean
Beschreibung
Did this show any evidence of infarction?
Datentyp
boolean
Beschreibung
Did this show any other finding of clinical significance?
Datentyp
boolean
Beschreibung
If Yes, specify
Datentyp
text
Beschreibung
Diagnostic Investigations - MRI Brain Scan
Beschreibung
If possible, please submit a copy of the report of the imaging studies
Datentyp
boolean
Beschreibung
If Yes, date of scan
Datentyp
date
Beschreibung
Did this show any evidence of intracerebral haemorrhage?
Datentyp
boolean
Beschreibung
Did this show any evidence of subarachnoid haemorrhage?
Datentyp
boolean
Beschreibung
Did this show any evidence of infarction?
Datentyp
boolean
Beschreibung
Did this show any other finding of clinical significance?
Datentyp
boolean
Beschreibung
If Yes, please specify
Datentyp
text
Beschreibung
Diagnostic Investigations - Cerebral Angiography
Beschreibung
If possible, please submit a copy of the report of the imaging studies
Datentyp
boolean
Beschreibung
If Yes, date of cerebral angiography
Datentyp
date
Beschreibung
any evidence of aneurysm or arteriovenous malformation?
Datentyp
boolean
Beschreibung
any significant obstructive disease or occlusion?
Datentyp
boolean
Beschreibung
any other finding or clinical significance?
Datentyp
boolean
Beschreibung
If Yes, specify
Datentyp
text
Beschreibung
Diagnostic Investigations - Lumbar Puncture
Beschreibung
Was a Lumbar Puncture performed?
Datentyp
boolean
Beschreibung
Date of Lumbar Puncture
Datentyp
date
Beschreibung
Was spinal fluid examination diagnostic of intracranial haemorrhage?
Datentyp
boolean
Beschreibung
If possible, please submit a copy of the report of the imaging studies
Datentyp
boolean
Beschreibung
If Yes, please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant finding(s):
Datentyp
text
Beschreibung
Date of Investigation
Datentyp
text
Beschreibung
Please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant finding(s):
Datentyp
text
Beschreibung
Date of Investigation
Datentyp
date
Beschreibung
Final Clinical Diagnosis
Beschreibung
Narrative
Beschreibung
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.
Datentyp
text
Beschreibung
Was modified Rankin Criteria evaluated at first follow-up visit for subject after stroke?
Datentyp
boolean
Beschreibung
Date of first follow-up visit for subject after stroke
Datentyp
date
Beschreibung
Outcome of Stroke Event
Datentyp
text
Ähnliche Modelle
Adjudication Events - Stroke / TIA
- StudyEvent: ODM