Informações:
Falhas:
ID
33841
Descrição
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
Palavras-chave
Versões (1)
- 03/01/2019 03/01/2019 -
Titular dos direitos
GSK group of companies
Transferido a
3 de janeiro de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Liver Event Assessments
- StudyEvent: ODM
Similar models
Liver Event Assessments
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Site
Item
Site
text
Subject
Item
Subject
text
CL Item
Liver Event Assessment (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
Item
Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
boolean
SAE / AE reference number
Item
SAE / AE reference number
integer
Date of assessment
Item
Date of assessment
date
Which liver chemistry result or exceeded protocol-defined investigational product stopping criteria?
Item
Which liver chemistry result or exceeded protocol-defined investigational product stopping criteria?
text
Which liver chemistry result or exceeded protocol-defined investigational product stopping criteria?
Code List
Which liver chemistry result or exceeded protocol-defined investigational product stopping criteria?
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspartate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Other (4)
If Other, specify
Item
If Other, specify
text
Is the subject 55 or older?
Item
Is the subject 55 or older?
boolean
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
If Yes, were the results normal?
Item
If Yes, were the results normal?
boolean
Were any liver biopsies performed?
Item
Were any liver biopsies performed?
boolean
Does the subject use herbals, complementary or alternative medicines?
Item
Does the subject use herbals, complementary or alternative medicines?
boolean
Did the subject fast or undergo significant dietary change in the past week?
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
Was a pharmacokinetic blood sample obtained?
Item
Was a pharmacokinetic blood sample obtained?
boolean
Date of sample taken
Item
Date of sample taken
date
Time of sample taken
Item
Time of sample taken
time
Record date and time of last investigational product dose prior to PK sample (if administered at subject's home, please do not record the time)
Item
Record date and time of last investigational product dose prior to PK sample (if administered at subject's home, please do not record the time)
datetime
The average number of units of alcohol consumed per week:
Item
The average number of units of alcohol consumed per week:
integer
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
Item
5. Epstein Barr virus infectious mononucleosis
text
Code List
5. Epstein Barr virus infectious mononucleosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
14. Specific condition:
Item
14. Specific condition:
text
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
15. Specific condition
Item
15. Specific condition
text
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
15. Specific condition
Item
15. Specific condition
text
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical conditions (3)