ID

33405

Beschreibung

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

Stichworte

Versionen (2)
  1. 06.11.18 06.11.18 -
  2. 07.12.18 07.12.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

7. Dezember 2018

DOI

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Lizenz

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

Englisch

Liver Events Form

1 Formulare  
  1. StudyEvent: ODM
    1. Liver Events Form
Liver Events
Beschreibung

Liver Events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
1. Is this liver event a serious adverse event?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C1519255
2. Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Beschreibung

check all that apply

Datentyp

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0008000
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C2133636
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.
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1522508
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C4086268
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C0439603
UMLS CUI [4]
C1710066
3. Is the subject age 55 or older?
Beschreibung

3. Is the subject age 55 or older?

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. If female, is the subject pregnant?
Beschreibung

4. If female, is the subject pregnant?

Datentyp

text

Alias
UMLS CUI [1]
C0032961
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)?
Beschreibung

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)?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0023884
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C1711359
UMLS CUI [3]
C1456803
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
UMLS CUI [6]
C0008310
If YES, were the results normal?
Beschreibung

If YES, were the results normal?

Datentyp

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0205307
6. Were any liver biopsies performed?
Beschreibung

6. Were any liver biopsies performed?

Datentyp

text

Alias
UMLS CUI [1]
C0193388
7. Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0002346
UMLS CUI [1,2]
C0242295
UMLS CUI [1,3]
C0281875
8. Did the subject fast or undergo significant dietary change in the past week?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015663
UMLS CUI [1,2]
C3671772
Investigational Product (Liver)
Beschreibung

Investigational Product (Liver)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0023884
When did the liver event occur?
Beschreibung

When did the liver event occur?

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C0023884
Start Date Investigational Product
Beschreibung

Start Date Investigational Product

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
End Date Investigational Product
Beschreibung

End Date Investigational Product

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
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Ähnliche Modelle

Liver Events Form

1 Formulare
  1. StudyEvent: ODM
    1. Liver Events Form
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
1. Is this liver event a serious adverse event?
Item
1. Is this liver event a serious adverse event?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
2. Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
text
C0023884 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C2133636 (UMLS CUI [2,2])
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
C0877248 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C4086268 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C0439603 (UMLS CUI [3,2])
C1710066 (UMLS CUI [4])
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
C0001779 (UMLS CUI [1])
Item
4. If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
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
C0011923 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C1456803 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
Item
If YES, were the results normal?
text
C0011923 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
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
C0193388 (UMLS CUI [1])
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
C0002346 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0281875 (UMLS CUI [1,3])
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
C0015663 (UMLS CUI [1,1])
C3671772 (UMLS CUI [1,2])
Item Group
Investigational Product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
When did the liver event occur?
text
C0877248 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
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
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date Investigational Product
Item
End Date Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
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