ID

29538

Beschreibung

Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: Liver Events

Stichworte

Versionen (2)
  1. 15.03.18 15.03.18 -
  2. 05.04.18 05.04.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. April 2018

DOI

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GSK Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) NCT01009463

Englisch

Liver Events

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

Liver Events

Alias
UMLS CUI-1
C1556667
Is this liver event a serious adverse event?
Beschreibung

liver event

Datentyp

boolean

Alias
UMLS CUI [1]
C1556667
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/ interruption criteria?
Beschreibung

liver chemistry result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
Is the subject age 55 or older?
Beschreibung

subject age

Datentyp

boolean

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

pregnant

Datentyp

integer

Alias
UMLS CUI [1]
C0032961
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

diagnostic imaging tests of the liver or hepatobiliary system

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1711359
UMLS CUI [1,3]
C0023884
If Yes, were the results normal?
Beschreibung

diagnostic imaging tests of the liver or hepatobiliary system results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1711359
UMLS CUI [1,3]
C0023884
Were any liver biopsies performed?
Beschreibung

liver biopsy

Datentyp

boolean

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

use of supplements or alternative medicines

Datentyp

boolean

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

dietary change

Datentyp

boolean

Alias
UMLS CUI [1]
C3671772
When did the liver event occur?
Beschreibung

liver event occurence

Datentyp

integer

Alias
UMLS CUI [1,1]
C1556667
UMLS CUI [1,2]
C2745955
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
Pharmacokinetics (Liver PK)
Beschreibung

Pharmacokinetics (Liver PK)

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0232741
UMLS CUI-3
C0008000
Was a pharmacokinetic blood sample obtained?
Beschreibung

pharmacokinetic blood sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
If Yes, date sample taken
Beschreibung

date sample taken

Datentyp

date

Alias
UMLS CUI [1]
C1302413
If Yes, time sample taken
Beschreibung

time sample taken

Datentyp

time

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0040223
If Yes, date of last investigational product dose prior to PK sample
Beschreibung

date of last investigational product dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
If Yes, time of last investigational product dose prior to PK sample
Beschreibung

time of last investigational product dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C0040223
If Yes, date of last medication dose prior to PK sample
Beschreibung

date of last medication dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1762893
If Yes, time of last medication dose prior to PK sample
Beschreibung

time of last medication dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C0040223
Medication: Insert drug name
Beschreibung

Medication name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Liver Disease Medical Conditions
Beschreibung

Liver Disease Medical Conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0262926
UMLS CUI-3
C1556667
Acute Viral Hepatitis A
Beschreibung

Acute Viral Hepatitis A

Datentyp

integer

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Beschreibung

Chronic Hepatitis B

Datentyp

integer

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Beschreibung

Chronic Hepatitis C

Datentyp

integer

Alias
UMLS CUI [1]
C0524910
Cytomegalovirus Hepatitis
Beschreibung

Cytomegalovirus Hepatitis

Datentyp

integer

Alias
UMLS CUI [1]
C0276252
Epstein Barr Virus Infectious Mononucleosis
Beschreibung

Epstein Barr Virus Infectious Mononucleosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C0021345
UMLS CUI [1,2]
C0014644
Herpes Simplex Hepatitis
Beschreibung

Herpes Simplex Hepatitis

Datentyp

integer

Alias
UMLS CUI [1]
C1963747
Alcoholic Liver Disease
Beschreibung

Alcoholic Liver Disease

Datentyp

integer

Alias
UMLS CUI [1]
C0023896
Non-alcoholic Steatohepatltls
Beschreibung

Non-alcoholic Steatohepatltls

Datentyp

integer

Alias
UMLS CUI [1]
C3241937
Fatty Liver
Beschreibung

Fatty Liver

Datentyp

integer

Alias
UMLS CUI [1]
C0015695
Hepatic Cirrhosis
Beschreibung

Hepatic Cirrhosis

Datentyp

integer

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Beschreibung

Hemochromatosis

Datentyp

integer

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Beschreibung

Autoimmune Hepatitis

Datentyp

integer

Alias
UMLS CUI [1]
C0241910
Gallbladder disease
Beschreibung

Gallbladder disease

Datentyp

integer

Alias
UMLS CUI [1]
C0016977
UMLS CUI [2]
C3275124
Drug related liver disease
Beschreibung

Drug related liver disease

Datentyp

integer

Other liver disease
Beschreibung

Other liver disease

Datentyp

integer

Alias
UMLS CUI [1]
C0023895
Other Medical Conditions
Beschreibung

Other Medical Conditions

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0009488
Drug Allergies
Beschreibung

Drug Allergies

Datentyp

integer

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
Rheumatoid Arthritis
Beschreibung

Rheumatoid Arthritis

Datentyp

integer

Alias
UMLS CUI [1]
C0003873
Psoriasis
Beschreibung

Psoriasis

Datentyp

integer

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Beschreibung

Thyroid Disease

Datentyp

integer

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Beschreibung

Inflammatory Bowel Disease

Datentyp

integer

Alias
UMLS CUI [1]
C0021390
Lupus
Beschreibung

Lupus

Datentyp

integer

Alias
UMLS CUI [1]
C0409974
Sjogrens Syndrome
Beschreibung

Sjogrens Syndrome

Datentyp

integer

Alias
UMLS CUI [1]
C1527336
Vitiligo
Beschreibung

Vitiligo

Datentyp

integer

Alias
UMLS CUI [1]
C0042900
Alcohol intake at onset of Liver Event
Beschreibung

Alcohol intake at onset of Liver Event

Alias
UMLS CUI-1
C0001948
UMLS CUI-2
C1556667
Does the subject consume alcohol?
Beschreibung

alcohol consumption

Datentyp

boolean

Alias
UMLS CUI [1]
C0001948
Yes, record the average number or units of alcohol consumed per week
Beschreibung

average number or units of alcohol consumed per week

Datentyp

float

Maßeinheiten
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per week
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Liver Events

1 Formulare
  1. StudyEvent: ODM
    1. Liver Events
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Liver Events
C1556667 (UMLS CUI-1)
liver event
Item
Is this liver event a serious adverse event?
boolean
C1556667 (UMLS CUI [1])
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/ interruption criteria?
integer
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
liver chemistry result
Code List
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/ interruption criteria?
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspactate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
nucleotidase (5)
CL Item
Gammaglutamyltranspeptidase (6)
CL Item
Other (7)
subject age
Item
Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
If female, is the subject pregnant?
integer
C0032961 (UMLS CUI [1])
pregnant
Code List
If female, is the subject pregnant?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
diagnostic imaging tests of the liver or hepatobiliary system
Item
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])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
diagnostic imaging tests of the liver or hepatobiliary system results
Item
If Yes, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
liver biopsy
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
use of supplements or alternative medicines
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C0002346 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0281875 (UMLS CUI [1,3])
dietary change
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C3671772 (UMLS CUI [1])
Item
When did the liver event occur?
integer
C1556667 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
liver event occurence
Code List
When did the liver event occur?
CL Item
During the treatment period (1)
CL Item
After the treatment period (2)
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])
Item Group
Pharmacokinetics (Liver PK)
C0031327 (UMLS CUI-1)
C0232741 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
pharmacokinetic blood sample
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
date sample taken
Item
If Yes, date sample taken
date
C1302413 (UMLS CUI [1])
time sample taken
Item
If Yes, time sample taken
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
date of last investigational product dose
Item
If Yes, date of last investigational product dose prior to PK sample
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
time of last investigational product dose
Item
If Yes, time of last investigational product dose prior to PK sample
time
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
date of last medication dose
Item
If Yes, date of last medication dose prior to PK sample
date
C0013227 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
time of last medication dose
Item
If Yes, time of last medication dose prior to PK sample
time
C0013227 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Medication name
Item
Medication: Insert drug name
text
C2360065 (UMLS CUI [1])
Item Group
Liver Disease Medical Conditions
C0023895 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C1556667 (UMLS CUI-3)
Item
Acute Viral Hepatitis A
integer
C0276434 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Acute Viral Hepatitis A
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Chronic Hepatitis B
integer
C0524909 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Chronic Hepatitis B
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Chronic Hepatitis C
integer
C0524910 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Chronic Hepatitis C
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Cytomegalovirus Hepatitis
integer
C0276252 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Cytomegalovirus Hepatitis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Epstein Barr Virus Infectious Mononucleosis
integer
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
Acute Viral Hepatitis A
Code List
Epstein Barr Virus Infectious Mononucleosis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Herpes Simplex Hepatitis
integer
C1963747 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Herpes Simplex Hepatitis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Alcoholic Liver Disease
integer
C0023896 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Alcoholic Liver Disease
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Non-alcoholic Steatohepatltls
integer
C3241937 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Non-alcoholic Steatohepatltls
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Fatty Liver
integer
C0015695 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Fatty Liver
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Hepatic Cirrhosis
integer
C0023890 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Hepatic Cirrhosis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Hemochromatosis
integer
C0018995 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Hemochromatosis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Autoimmune Hepatitis
integer
C0241910 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Autoimmune Hepatitis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Gallbladder disease
integer
C0016977 (UMLS CUI [1])
C3275124 (UMLS CUI [2])
Acute Viral Hepatitis A
Code List
Gallbladder disease
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Drug related liver disease
integer
Acute Viral Hepatitis A
Code List
Drug related liver disease
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Other liver disease
integer
C0023895 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Other liver disease
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Other Medical Conditions
C0262926 (UMLS CUI-1)
C0009488 (UMLS CUI-2)
Item
Drug Allergies
integer
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Acute Viral Hepatitis A
Code List
Drug Allergies
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Rheumatoid Arthritis
integer
C0003873 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Rheumatoid Arthritis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Psoriasis
integer
C0033860 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Psoriasis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Thyroid Disease
integer
C0040128 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Thyroid Disease
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Inflammatory Bowel Disease
integer
C0021390 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Inflammatory Bowel Disease
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Lupus
integer
C0409974 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Lupus
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Sjogrens Syndrome
integer
C1527336 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Sjogrens Syndrome
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Vitiligo
integer
C0042900 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Vitiligo
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Alcohol intake at onset of Liver Event
C0001948 (UMLS CUI-1)
C1556667 (UMLS CUI-2)
alcohol consumption
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
average number or units of alcohol consumed per week
Item
Yes, record the average number or units of alcohol consumed per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
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