ID

32566

Beskrivning

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Nyckelord

Versioner (2)
  1. 2018-11-06 2018-11-06 -
  2. 2018-12-07 2018-12-07 -
Rättsinnehavare

GSK group of companies

Uppladdad den

6 november 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

Engelsk

Liver Events Form

1 Formulär  
  1. StudyEvent: ODM
    1. Liver Events Form
Liver Events
Beskrivning

Liver Events

1. Is this liver event a serious adverse event?
Beskrivning

If YES, please complete liver event forms and serious adverse event form immediately

Datatyp

boolean

2. Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Beskrivning

check all that apply

Datatyp

text

Record the details of any Adverse Events or exacerbations of Adverse Events on the AE or SAE forms. Exacerbations of AE include increases in frequency and severity.
Beskrivning

Record the details of any Adverse Events or exacerbations of Adverse Events on the AE or SAE forms. Exacerbations of AE include increases in frequency and severity.

Datatyp

text

3. Is the subject age 55 or older?
Beskrivning

3. Is the subject age 55 or older?

Datatyp

boolean

4. If female, is the subject pregnant?
Beskrivning

4. If female, is the subject pregnant?

Datatyp

text

5. Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Beskrivning

5. Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?

Datatyp

boolean

If YES, were the results normal?
Beskrivning

If YES, were the results normal?

Datatyp

text

6. Were any liver biopsies performed?
Beskrivning

6. Were any liver biopsies performed?

Datatyp

text

7. Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Beskrivning

7. Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?

Datatyp

text

8. Did the subject fast or undergo significant dietary change in the past week?
Beskrivning

8. Did the subject fast or undergo significant dietary change in the past week?

Datatyp

boolean

Investigational Product (Liver)
Beskrivning

Investigational Product (Liver)

When did the liver event occur?
Beskrivning

When did the liver event occur?

Datatyp

text

Start Date Investigational Product
Beskrivning

Start Date Investigational Product

Datatyp

date

End Date Investigational Product
Beskrivning

End Date Investigational Product

Datatyp

date

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Similar models

Liver Events Form

1 Formulär
  1. StudyEvent: ODM
    1. Liver Events Form
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Liver Events
1. Is this liver event a serious adverse event?
Item
1. Is this liver event a serious adverse event?
boolean
Item
2. Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
text
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Code List
2. Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
CL Item
ALT (1)
CL Item
AST (2)
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
5´ nucleotidase (5)
CL Item
Gammaglutamyltranspeptidase (6)
CL Item
Other (7)
Item
Record the details of any Adverse Events or exacerbations of Adverse Events on the AE or SAE forms. Exacerbations of AE include increases in frequency and severity.
text
Record the details of any Adverse Events or exacerbations of Adverse Events on the AE or SAE forms. Exacerbations of AE include increases in frequency and severity.
Code List
Record the details of any Adverse Events or exacerbations of Adverse Events on the AE or SAE forms. Exacerbations of AE include increases in frequency and severity.
CL Item
It is particularly important to record any significant hypotension immediately prior to or concomitant with ALT elevation. (1)
CL Item
It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study (2)
3. Is the subject age 55 or older?
Item
3. Is the subject age 55 or older?
boolean
Item
4. If female, is the subject pregnant?
text
If female, is the subject pregnant?
Code List
4. If female, is the subject pregnant?
CL Item
Yes (ensure Pregnancy Notification Form has been completed) (1)
CL Item
No (2)
CL Item
Not applicable (3)
5. Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Item
5. Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
Item
If YES, were the results normal?
text
If YES, were the results normal?
Code List
If YES, were the results normal?
CL Item
Yes (1)
CL Item
No, record the details on the Imaging form and ensure the overall diagnosis indicated by imaging is captured on the SAE or AE forms. (2)
Item
6. Were any liver biopsies performed?
text
6. Were any liver biopsies performed?
Code List
6. Were any liver biopsies performed?
CL Item
Yes, complete Liver Biopsy form (1)
CL Item
No (2)
Item
7. Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
text
7. Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Code List
7. Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
CL Item
Yes, record on the appropriate Concomitant Medication form (1)
CL Item
No (2)
8. Did the subject fast or undergo significant dietary change in the past week?
Item
8. Did the subject fast or undergo significant dietary change in the past week?
boolean
Item Group
Investigational Product (Liver)
Item
When did the liver event occur?
text
When did the liver event occur?
Code List
When did the liver event occur?
CL Item
During the treatment period ([D])
CL Item
After the treatment period ([A])
Start Date Investigational Product
Item
Start Date Investigational Product
date
End Date Investigational Product
Item
End Date Investigational Product
date
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