ID
33556
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
Keywords
Versions (1)
- 12/12/18 12/12/18 -
Copyright Holder
GSK group of companies
Uploaded on
December 12, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Visit 10: Adverse Events/Severe Adverse Event Form
- StudyEvent: ODM
Description
Section 1
Description
Adverse Event Number
Data type
integer
Description
Diagnosis or Sign/Symptom
Data type
text
Description
Type of event
Data type
text
Description
Start date
Data type
date
Description
End date
Data type
date
Description
Outcome
Data type
text
Description
Maximum intensity
Data type
text
Description
action with investigational products
Data type
text
Description
If subject withdrew from active treatment period, check 'Adverse Event'; If subject withdrew from follow-up period, check 'Adverse event' on Study Conclusion Page.
Data type
boolean
Description
Relationship to Investigational Prosuct(s)
Data type
boolean
Description
If Yes, please record on Concomitant Medications/Non-Drug Therapies page.
Data type
boolean
Description
seriousness
Data type
boolean
Description
Section 2 - Seriousness
Description
Section 3 - Demography Data
Description
Section 4 - Adverse event after Investigational product withdrawal
Description
Adverse Event Number
Data type
integer
Description
If investigational Product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
Data type
boolean
Description
Section 5 - Possible Causes of SAE
Description
Adverse Event Number
Data type
integer
Description
Check all that apply
Data type
text
Description
If Other, specify
Data type
text
Description
Section 6 - Relevant Medical Conditions
Description
Relevant Medical Condition
Data type
text
Description
Diagnosis
Data type
text
Description
Date of Onset
Data type
date
Description
Condition Present at Time of the SAE?
Data type
boolean
Description
If No, record date of last occurrence
Data type
date
Description
Section 7 - Relevant Risk Factors
Description
Adverse Event Number
Data type
integer
Description
e.g., smoking, alcohol, diet, drug abuse, occupational hazard
Data type
text
Description
Other relevant risk factors
Data type
text
Description
Section 8 - Relevant Concomitant Medications
Description
Adverse Event Number
Data type
integer
Description
include details of any concomitant medication(s) which may have contributed to the event
Data type
text
Description
Dose
Data type
text
Description
Unit
Data type
text
Description
Frequency
Data type
text
Description
Route
Data type
text
Description
Taken prior to study
Data type
boolean
Description
Start Date
Data type
date
Description
Stop Date
Data type
date
Description
Ongoing Medication?
Data type
boolean
Description
Reason for medication
Data type
text
Description
Section 9 - Details of Investigational Product
Description
Section 10 - Relevant Assessment
Description
Adverse Event Number
Data type
integer
Description
e.g. laboratory data with units and normal range
Data type
text
Description
details of relevant assessment
Data type
text
Description
details of relevant assessment
Data type
text
Description
Section 11 - Narrative Remarks
Similar models
Visit 10: Adverse Events/Severe Adverse Event Form
- StudyEvent: ODM