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ID
32949
Beschrijving
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
Trefwoorden
Versies (3)
- 09-11-18 09-11-18 -
- 16-11-18 16-11-18 -
- 21-11-18 21-11-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
21 november 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138
Medical Conditions, Family History, Disease Duration, Vital Signs, Candidiasis Examination, Electronically Transferred Lab Data - Screening
Similar models
Medical Conditions, Family History, Disease Duration, Vital Signs, Candidiasis Examination, Electronically Transferred Lab Data - Screening
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Medical Conditions - Cardiac Disorders
C0012634 (UMLS CUI-1)
C0018799 (UMLS CUI-2)
C0018799 (UMLS CUI-2)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
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)
C0014130 (UMLS CUI-2)
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])
C3846158 (UMLS CUI [1,2])
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)
C0015397 (UMLS CUI-2)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
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)
C0042373 (UMLS CUI-2)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
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)
C0851358 (UMLS CUI-2)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
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)
C0009450 (UMLS CUI-2)
C0851341 (UMLS CUI-3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (4)
CL Item
No Medical Condition (5)
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])
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])
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])
Date of initial diagnosis
Item
Date of initial diagnosis
date
C2316983 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
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])
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])
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])
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])
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)
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])
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])
C0444686 (UMLS CUI [1,2])
Item Group
Candidiasis Examination
C0006840 (UMLS CUI-1)
C4321457 (UMLS CUI-2)
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)
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])
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])
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])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])