ID

41931

Descripción

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Palabras clave

  1. 15/2/21 15/2/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

15 de febrero de 2021

DOI

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Licencia

Creative Commons BY 4.0

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Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)

Unscheduled Clinical Chemistry; Unscheduled Haematology; Unscheduled Urinalysis

Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Local Laboratory - Clinical Chemistry
Descripción

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Date and time sample taken (Clinical Chemistry)
Descripción

Date and time sample taken (Clinical Chemistry)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0008000
Local Laboratory - Clinical Chemistry
Descripción

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Clinical Chemistry Test
Descripción

Clinical Chemistry Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0525044
Clinical Chemistry Test Result
Descripción

Clinical Chemistry Test Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0587081
Local Laboratory - Haematology
Descripción

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
Date and time sample taken (Haematology)
Descripción

Date and time sample taken (Haematology)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0018941
Local Laboratory - Haematology
Descripción

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
Haematology Test
Descripción

Haematology Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018941
Haematologic Test Result
Descripción

Haematologic Test Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0587081
Urinalysis - Local
Descripción

Urinalysis - Local

Alias
UMLS CUI-1
C0042014
Date and time sample taken (Urinalysis)
Descripción

Date and time sample taken (Urinalysis)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Result of dipstick
Descripción

Result of dipstick

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Urinalysis - Local
Descripción

Urinalysis - Local

Alias
UMLS CUI-1
C0042014
Urinalysis Test
Descripción

Urinalysis Test

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022885
Urinalysis Test Result
Descripción

Urinalysis Test Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0439565
Urinalysis - Microscopy
Descripción

Urinalysis - Microscopy

Alias
UMLS CUI-1
C0430397
Was sedimentary microscopy performed?
Descripción

Was sedimentary microscopy performed?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
Urinalysis - Microscopy
Descripción

Urinalysis - Microscopy

Alias
UMLS CUI-1
C0430397
Urinalysis - Microscopy Test
Descripción

Urinalysis - Microscopy Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0430397
Urinalysis - Microscopy Test Result
Descripción

Urinalysis - Microscopy Test Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0587081

Similar models

Unscheduled Clinical Chemistry; Unscheduled Haematology; Unscheduled Urinalysis

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Date and time sample taken (Clinical Chemistry)
Item
Date and time sample taken (Clinical Chemistry)
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0008000 (UMLS CUI [2])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Clinical Chemistry Test
integer
C0525044 (UMLS CUI [1])
Code List
Clinical Chemistry Test
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Bicarbonate (4)
CL Item
Urea (5)
CL Item
Creatinine (6)
CL Item
Glucose (7)
CL Item
Calcium (8)
CL Item
Phosphate (9)
CL Item
Uric Acid (10)
CL Item
Total Bilirubin (11)
CL Item
Alkaline Phosphatase (12)
CL Item
Gamma GT (13)
CL Item
Aspartate Transferase (AST) (14)
CL Item
Alanine Transferase (ALT) (15)
CL Item
Total Protein (16)
CL Item
Albumin (17)
CL Item
Globulin (18)
Clinical Chemistry Test Result
Item
Clinical Chemistry Test Result
text
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Date and time sample taken (Haematology)
Item
Date and time sample taken (Haematology)
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Item
Haematology Test
integer
C0018941 (UMLS CUI [1])
Code List
Haematology Test
CL Item
Haemoglobin (1)
CL Item
Red Blood Cells (2)
CL Item
Hematocrit (3)
CL Item
MCV (4)
CL Item
MCH (5)
CL Item
MCHC (6)
CL Item
White Blood Cells (7)
CL Item
Neutrophils (8)
CL Item
Lymphocytes (9)
CL Item
Monocytes (10)
CL Item
eosinophils (11)
CL Item
Basophils (12)
CL Item
Platelets (13)
Haematologic Test Result
Item
Haematologic Test Result
text
C0018941 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item Group
Urinalysis - Local
C0042014 (UMLS CUI-1)
Date and time sample taken (Urinalysis)
Item
Date and time sample taken (Urinalysis)
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Result of dipstick
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Result of dipstick
CL Item
Negative  (NEG)
CL Item
Positive (If positive, record results of individual tests)  (POS)
CL Item
No result (NR)
Item Group
Urinalysis - Local
C0042014 (UMLS CUI-1)
Item
Urinalysis Test
integer
C0042014 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Code List
Urinalysis Test
CL Item
Leucocyte Esterase (1)
CL Item
Nitrite (2)
CL Item
Urobilinogen (3)
CL Item
Protein (4)
CL Item
Urine pH (5)
CL Item
Blood (6)
CL Item
Specific Gravity (7)
CL Item
Ketones (8)
CL Item
Bilirubin (9)
CL Item
Glucose (10)
Item
Urinalysis Test Result
text
C0042014 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Code List
Urinalysis Test Result
CL Item
none or negative  (NEG)
CL Item
trace  (TRA)
CL Item
+ or 1+  (1+)
CL Item
++ or 2+  (2+)
CL Item
+++ or 3+  (3+)
CL Item
++++ or 4+  (4+)
CL Item
+++++ or 5+ (5+)
Item Group
Urinalysis - Microscopy
C0430397 (UMLS CUI-1)
Was sedimentary microscopy performed?
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Item Group
Urinalysis - Microscopy
C0430397 (UMLS CUI-1)
Item
Urinalysis - Microscopy Test
integer
C0430397 (UMLS CUI [1])
Code List
Urinalysis - Microscopy Test
CL Item
WBC  (1)
CL Item
RBC  (2)
CL Item
Hyaline casts  (3)
CL Item
Granular casts  (4)
CL Item
Cellular casts (5)
Urinalysis - Microscopy Test Result
Item
Urinalysis - Microscopy Test Result
text
C0430397 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])

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