ID
33841
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-01-03 2019-01-03 -
Rättsinnehavare
GSK group of companies
Uppladdad den
3 januari 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Liver Event Assessments
- StudyEvent: ODM
Beskrivning
Liver Events Assessment
Beskrivning
If Yes, stop investigational product, complete date stopped on Investigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following test: 1.Blood sample for PK analysis, obtained within three half-lives(21 days) of last dose; 2.Hepatitis A: IgM antibody; 3, Hepatitis B surface antigen and Core Antibody (IgM); 4. Hepatitis C: RNA; 5.Hepatitis E IgM antibody (if subject resides or has travelled in past 3 month outside the USA or Canada); 6. Cytomegalovirus IgM antibody (CMV); 7. EBV (Epstein Barr Viral capsid antigen IgM antibody)or if unavailable, obtain heterophile antibody or monospot testing; 8.CPK (Serum creatine phosphokinase); 9. LDH (lactate dehydrogenase); 10. Bilirubin fractionation, if bilirubin >=1.5xULN (If ALT >=3xULN and bilirubin >1.5xULN(>35% direct), the following are needed: anti-nuclear antibody, anti-smooth muscle antibody, tape 1 anti-liver kidney microsomal antibodies, liver imaging).
Datatyp
boolean
Beskrivning
Liver Events
Beskrivning
SAE / AE reference number
Datatyp
integer
Beskrivning
Date of assessment
Datatyp
date
Beskrivning
check all that apply
Datatyp
text
Beskrivning
If Other, specify
Datatyp
text
Beskrivning
Is the subject 55 or older?
Datatyp
boolean
Beskrivning
if Yes, complete the Pregnancy Notification Form
Datatyp
text
Beskrivning
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)?
Datatyp
boolean
Beskrivning
if No, record the details on the Non-Serious Adverse Events form or Serious Adverse Events form.
Datatyp
boolean
Beskrivning
Were any liver biopsies performed?
Datatyp
boolean
Beskrivning
If Yes, record on the appropriate Concomitant Medication form
Datatyp
boolean
Beskrivning
Did the subject fast or undergo significant dietary change in the past week?
Datatyp
boolean
Beskrivning
An unscheduled PK blood sample must be obtained within three half-lives (21 days) of last dose.
Datatyp
boolean
Beskrivning
Date of sample taken
Datatyp
date
Beskrivning
Time of sample taken
Datatyp
time
Beskrivning
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)
Datatyp
datetime
Beskrivning
Alcohol Intake
Beskrivning
Liver Disease Medical Conditions
Beskrivning
1. Acute viral Hepatitis A
Datatyp
text
Beskrivning
2. Chronic Hepatitis B
Datatyp
text
Beskrivning
3. Chronic Hepatitis C
Datatyp
text
Beskrivning
4. Cytomegalovirus Hepatitis
Datatyp
text
Beskrivning
5. Epstein Barr virus infectious mononucleosis
Datatyp
text
Beskrivning
6. Herpes Simplex Hepatitis
Datatyp
text
Beskrivning
7. Alcoholic liver disease
Datatyp
text
Beskrivning
8. Non-alcoholic steatohepatitis
Datatyp
text
Beskrivning
9. Fatty Liver
Datatyp
text
Beskrivning
10. Hepatic Cirrhosis
Datatyp
text
Beskrivning
11. Hemochromatosis
Datatyp
text
Beskrivning
12. Autoimmune Hepatitis
Datatyp
text
Beskrivning
13. Gallbladder disease or biliary disease
Datatyp
text
Beskrivning
Drug Related Liver Disease Conditions
Beskrivning
specify here
Datatyp
text
Beskrivning
Status of condition
Datatyp
text
Beskrivning
15. Specific condition
Datatyp
text
Beskrivning
Status of condition
Datatyp
text
Beskrivning
15. Specific condition
Datatyp
text
Beskrivning
Status of condition
Datatyp
text
Beskrivning
Other Medical Conditions
Beskrivning
17. Drug allergies
Datatyp
text
Beskrivning
18. Rheumatoid Arthritis
Datatyp
text
Beskrivning
19. Psoriasis
Datatyp
text
Beskrivning
20. Thyroid disease
Datatyp
text
Beskrivning
21. Inflammatory bowel disease
Datatyp
text
Beskrivning
22. Lupus
Datatyp
text
Beskrivning
23. Sjoren's syndrome
Datatyp
text
Beskrivning
24. Vitiligo
Datatyp
text
Similar models
Liver Event Assessments
- StudyEvent: ODM