ID

32949

Beschreibung

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

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  3. 21.11.18 21.11.18 -
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GlaxoSmithKline

Hochgeladen am

21. November 2018

DOI

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Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138

Englisch

Medical Conditions, Family History, Disease Duration, Vital Signs, Candidiasis Examination, Electronically Transferred Lab Data - Screening

1 Formulare  
Medical Conditions - Cardiac Disorders
Beschreibung

Medical Conditions - Cardiac Disorders

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0018799
Coronary Artery Disease
Beschreibung

Coronary Artery Disease

Datentyp

integer

Alias
UMLS CUI [1]
C1956346
Myocardial Infarction
Beschreibung

Myocardial Infarction

Datentyp

integer

Alias
UMLS CUI [1]
C0027051
Arrythmia
Beschreibung

Arrythmia

Datentyp

integer

Alias
UMLS CUI [1]
C0003811
Congestive Heart Failure
Beschreibung

Congestive Heart Failure

Datentyp

integer

Alias
UMLS CUI [1]
C0018802
Medical Conditions - Endocrine Disorders
Beschreibung

Medical Conditions - Endocrine Disorders

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0014130
Cushing's Syndrome
Beschreibung

Cushing's Syndrome

Datentyp

integer

Alias
UMLS CUI [1]
C0010481
Adrenal Suppression
Beschreibung

Adrenal Suppression

Datentyp

integer

Alias
UMLS CUI [1,1]
C0521428
UMLS CUI [1,2]
C3846158
Medical Conditions - Eye Disorders
Beschreibung

Medical Conditions - Eye Disorders

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0015397
Cataract
Beschreibung

Cataract

Datentyp

integer

Alias
UMLS CUI [1]
C0086543
Glaucoma
Beschreibung

Glaucoma

Datentyp

integer

Alias
UMLS CUI [1]
C0017601
Medical Conditions - Vascular Disorders
Beschreibung

Medical Conditions - Vascular Disorders

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0042373
Hypertension
Beschreibung

Hypertension

Datentyp

integer

Alias
UMLS CUI [1]
C0020538
Cerebrovascular accident
Beschreibung

Cerebrovascular accident

Datentyp

integer

Alias
UMLS CUI [1]
C0038454
Medical Conditions - Metabolism and Nutrition Disorders
Beschreibung

Medical Conditions - Metabolism and Nutrition Disorders

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0851358
Hypercholesterolemia
Beschreibung

Hypercholesterolemia

Datentyp

integer

Alias
UMLS CUI [1]
C0020443
Diabetes Mellitus
Beschreibung

Diabetes Mellitus

Datentyp

integer

Alias
UMLS CUI [1]
C0011849
Osteoporosis
Beschreibung

Osteoporosis

Datentyp

integer

Alias
UMLS CUI [1]
C0029456
Medical Conditions - Infections and Infestations
Beschreibung

Medical Conditions - Infections and Infestations

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0009450
UMLS CUI-3
C0851341
Pneumonia
Beschreibung

Pneumonia

Datentyp

integer

Alias
UMLS CUI [1]
C0032285
Family History
Beschreibung

Family History

Alias
UMLS CUI-1
C0241889
Is there a family history of premature coronary artery disease in women < 65 years or men < 55 years in first degree relatives only (e.g., biological mother or father, biological brother or sister, biological son or daughter)? Halfsiblings are considered first degree relatives.
Beschreibung

Family History of premature coronary artery disease

Datentyp

text

Alias
UMLS CUI [1]
C0241889
UMLS CUI [2]
C1867743
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0001779
UMLS CUI [5,1]
C1517194
UMLS CUI [5,2]
C0337486
UMLS CUI [5,3]
C0337494
UMLS CUI [5,4]
C0337528
UMLS CUI [5,5]
C0337515
UMLS CUI [5,6]
C3844044
Disease Duration
Beschreibung

Disease Duration

Alias
UMLS CUI-1
C0872146
Date of initial diagnosis
Beschreibung

Date of initial diagnosis

Datentyp

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0205265
Disease Duration in years
Beschreibung

Disease Duration in years

Datentyp

float

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C0872146
UMLS CUI [1,2]
C0439234
years
Disease Duration in months
Beschreibung

Disease Duration in months

Datentyp

float

Maßeinheiten
  • months
Alias
UMLS CUI [1,1]
C0872146
UMLS CUI [1,2]
C0439231
months
Duration of Asthma/ COPD/ Rhinitis
Beschreibung

Duration of Asthma/ COPD/ Rhinitis

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0004096
UMLS CUI [2,1]
C0449238
UMLS CUI [2,2]
C0024117
UMLS CUI [3,1]
C0449238
UMLS CUI [3,2]
C0035455
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/time
Beschreibung

Actual date/time

Datentyp

datetime

Alias
UMLS CUI [1]
C1264639
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beschreibung

Body mass index

Datentyp

integer

Alias
UMLS CUI [1]
C1305855
Blood pressure systolic/ disatolic (mmHg / mmHg)
Beschreibung

Blood pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Subject position
Beschreibung

(Positon must be consistent throughout the study)

Datentyp

integer

Alias
UMLS CUI [1]
C1262869
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Respiration rate
Beschreibung

Respiration rate

Datentyp

integer

Maßeinheiten
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Calculated Subject position
Beschreibung

Calculated Subject position

Datentyp

text

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0444686
Candidiasis Examination
Beschreibung

Candidiasis Examination

Alias
UMLS CUI-1
C0006840
UMLS CUI-2
C4321457
Does the subject have clinical visual evidence of oropharyngeal candidiasis?
Beschreibung

Oropharyngeal candidiasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0919659
Electronically transferred lab data
Beschreibung

Electronically transferred lab data

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1320722
Date Sample(s) Taken
Beschreibung

Date Sample(s) Taken

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Haem Lab type code
Beschreibung

Haem Lab type code

Datentyp

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Chem Lab type code
Beschreibung

Chem Lab type code

Datentyp

text

Alias
UMLS CUI [1,1]
C0005774
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Urin Lab type code
Beschreibung

Urin Lab type code

Datentyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
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Ähnliche Modelle

Medical Conditions, Family History, Disease Duration, Vital Signs, Candidiasis Examination, Electronically Transferred Lab Data - Screening

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Medical Conditions - Cardiac Disorders
C0012634 (UMLS CUI-1)
C0018799 (UMLS CUI-2)
Item
Coronary Artery Disease
integer
C1956346 (UMLS CUI [1])
Coronary Artery Disease
Code List
Coronary Artery Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item
Myocardial Infarction
integer
C0027051 (UMLS CUI [1])
Myocardial Infarction
Code List
Myocardial Infarction
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item
Arrythmia
integer
C0003811 (UMLS CUI [1])
Arrythmia
Code List
Arrythmia
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item
Congestive Heart Failure
integer
C0018802 (UMLS CUI [1])
Congestive Heart Failure
Code List
Congestive Heart Failure
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item Group
Medical Conditions - Endocrine Disorders
C0012634 (UMLS CUI-1)
C0014130 (UMLS CUI-2)
Item
Cushing's Syndrome
integer
C0010481 (UMLS CUI [1])
Cushing's Syndrome
Code List
Cushing's Syndrome
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item
Adrenal Suppression
integer
C0521428 (UMLS CUI [1,1])
C3846158 (UMLS CUI [1,2])
Adrenal Suppression
Code List
Adrenal Suppression
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item Group
Medical Conditions - Eye Disorders
C0012634 (UMLS CUI-1)
C0015397 (UMLS CUI-2)
Item
Cataract
integer
C0086543 (UMLS CUI [1])
Cataract
Code List
Cataract
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item
Glaucoma
integer
C0017601 (UMLS CUI [1])
Glaucoma
Code List
Glaucoma
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item Group
Medical Conditions - Vascular Disorders
C0012634 (UMLS CUI-1)
C0042373 (UMLS CUI-2)
Item
Hypertension
integer
C0020538 (UMLS CUI [1])
Hypertension
Code List
Hypertension
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item
Cerebrovascular accident
integer
C0038454 (UMLS CUI [1])
Cerebrovascular accident
Code List
Cerebrovascular accident
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item Group
Medical Conditions - Metabolism and Nutrition Disorders
C0012634 (UMLS CUI-1)
C0851358 (UMLS CUI-2)
Item
Hypercholesterolemia
integer
C0020443 (UMLS CUI [1])
Hypercholesterolemia
Code List
Hypercholesterolemia
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item
Diabetes Mellitus
integer
C0011849 (UMLS CUI [1])
Diabetes Mellitus
Code List
Diabetes Mellitus
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item
Osteoporosis
integer
C0029456 (UMLS CUI [1])
Osteoporosis
Code List
Osteoporosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item Group
Medical Conditions - Infections and Infestations
C0012634 (UMLS CUI-1)
C0009450 (UMLS CUI-2)
C0851341 (UMLS CUI-3)
Item
Pneumonia
integer
C0032285 (UMLS CUI [1])
Pneumonia
Code List
Pneumonia
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
Item Group
Family History
C0241889 (UMLS CUI-1)
Item
Is there a family history of premature coronary artery disease in women < 65 years or men < 55 years in first degree relatives only (e.g., biological mother or father, biological brother or sister, biological son or daughter)? Halfsiblings are considered first degree relatives.
text
C0241889 (UMLS CUI [1])
C1867743 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C1517194 (UMLS CUI [5,1])
C0337486 (UMLS CUI [5,2])
C0337494 (UMLS CUI [5,3])
C0337528 (UMLS CUI [5,4])
C0337515 (UMLS CUI [5,5])
C3844044 (UMLS CUI [5,6])
Family History of premature coronary artery disease
Code List
Is there a family history of premature coronary artery disease in women < 65 years or men < 55 years in first degree relatives only (e.g., biological mother or father, biological brother or sister, biological son or daughter)? Halfsiblings are considered first degree relatives.
CL Item
Yes ([Y])
CL Item
No ([N])
CL Item
Unknown ([U])
Item Group
Disease Duration
C0872146 (UMLS CUI-1)
Date of initial diagnosis
Item
Date of initial diagnosis
date
C2316983 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Disease Duration in years
Item
Disease Duration in years
float
C0872146 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Disease Duration in months
Item
Disease Duration in months
float
C0872146 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
Item
Duration of Asthma/ COPD/ Rhinitis
integer
C0449238 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0449238 (UMLS CUI [2,1])
C0024117 (UMLS CUI [2,2])
C0449238 (UMLS CUI [3,1])
C0035455 (UMLS CUI [3,2])
Duration of Asthma/ COPD/ Rhinitis
Code List
Duration of Asthma/ COPD/ Rhinitis
CL Item
<6 months (1)
CL Item
>=6 months to <1 year (2)
CL Item
>=6 months to 5 years (29)
CL Item
<1 year (26)
CL Item
>=1 year to <2 years (3)
CL Item
>=1 year to <3 years (4)
CL Item
<2 years (5)
CL Item
>=1 year to <5 years (6)
CL Item
>=3 years (7)
CL Item
>=2 years to <5 years (8)
CL Item
<5 years (9)
CL Item
>=5 years (10)
CL Item
>=5 years to <10 years (11)
CL Item
>=10 years (12)
CL Item
>=10 years to <15 years (13)
CL Item
>=15 years (14)
CL Item
>=15 years to <20 years (15)
CL Item
>=20 years (16)
CL Item
>=20 years to <25 years (17)
CL Item
>=25 years (18)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
integer
C1305855 (UMLS CUI [1])
Blood pressure
Item
Blood pressure systolic/ disatolic (mmHg / mmHg)
text
C0005823 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1])
Subject position
Code List
Subject position
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
CL Item
Semi-supine (4)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Calculated Subject position
Item
Calculated Subject position
text
C1262869 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
Item Group
Candidiasis Examination
C0006840 (UMLS CUI-1)
C4321457 (UMLS CUI-2)
Oropharyngeal candidiasis
Item
Does the subject have clinical visual evidence of oropharyngeal candidiasis?
boolean
C0919659 (UMLS CUI [1])
Item Group
Electronically transferred lab data
C0022885 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
Date Sample(s) Taken
Item
Date Sample(s) Taken
date
C1302413 (UMLS CUI [1])
Haem Lab type code
Item
Haem Lab type code
text
C0018941 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Urin Lab type code
Item
Urin Lab type code
text
C0042014 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
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