ID

41752

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

Versiones (1)
  1. 12/1/21 12/1/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12 de enero de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)

Inglés

Screening - Serious Adverse Event; Local Laboratory; Urinalysis; Serology - Screen for HIV Antibody and Hepatitis B & C

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Serious Adverse Event
Descripción

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Did the subject experience a Serious Adverse Event during the study?
Descripción

If Yes, record details of the subject's ongoing Serious Adverse Event in the Sersious Adverse Event section (Module 2).

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
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]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
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

If the laboratory results meet the protocol definition of an adverse event, record the details on the Non-Seriopus Adverse Events page or Serious Adverse Event page.

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]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1264639
Local Laboratory - Haematology
Descripción

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematology Test
Descripción

Haematology Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018941
Haematology Test Result
Descripción

If the laboratory results meet the protocol definition of an adverse event, record the details in the Non-Serious Adverse Events or Serious Adverse Event section(s).

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1274040
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]
C0042014
Urinalysis Test Result
Descripción

Urinalysis Test Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1274040
Urinalysis - Microscopy
Descripción

Urinalysis - Microscopy

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

Note: Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.

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

Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) section(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0587081
Local Laboratory - Unscheduled Clinical Chemistry
Descripción

Local Laboratory - Unscheduled Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
UMLS CUI-3
C3854240
Date and time sample taken (Unscheduled Clinical Chemistry)
Descripción

Date and time sample taken (Unscheduled Clinical Chemistry)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C3854240
UMLS CUI [2,1]
C0200345
UMLS CUI [2,2]
C1264639
Local Laboratory - Unscheduled Clinical Chemistry
Descripción

Local Laboratory - Unscheduled Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
UMLS CUI-3
C3854240
Clinical Chemistry Test
Descripción

Clinical Chemistry Test

Tipo de datos

integer

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

If the laboratory results meet the protocol definition of an adverse event, record the details on the Non-Serious Adverse Events page or Serious Adverse Event page.

Tipo de datos

text

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

Local Laboratory - Unscheduled Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
UMLS CUI-3
C3854240
Date and time sample taken (Unscheduled Haematology)
Descripción

Date and time sample taken (Unscheduled Haematology)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C3854240
UMLS CUI [2,1]
C0870078
UMLS CUI [2,2]
C1264639
Local Laboratory - Unscheduled Haematology
Descripción

Local Laboratory - Unscheduled Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
UMLS CUI-3
C3854240
Haematology Test
Descripción

Haematology Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018941
Haematology Test Result
Descripción

If the laboratory results meet the protocol definition of an adverse event, record the details in the Non-Serious Adverse Events or Serious Adverse Event section(s).

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1274040
Unscheduled Urinalysis - Local
Descripción

Unscheduled Urinalysis - Local

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C3854240
Date and time sample taken (Unscheduled Urinalysis)
Descripción

Date and time sample taken (Unscheduled Urinalysis)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C3854240
UMLS CUI [2,1]
C0200345
UMLS CUI [2,2]
C1264639
Result of dipstick
Descripción

Result of dipstick

Tipo de datos

text

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

Unscheduled Urinalysis - Local

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C3854240
Urinalysis Test
Descripción

Urinalysis Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0042014
Urinalysis Test Result
Descripción

Urinalysis Test Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1274040
Urinalysis - Microscopy (Unscheduled)
Descripción

Urinalysis - Microscopy (Unscheduled)

Alias
UMLS CUI-1
C0430397
UMLS CUI-2
C3854240
Was sedimentary microscopy performed?
Descripción

Note: Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.

Tipo de datos

boolean

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

Urinalysis - Microscopy (Unscheduled)

Alias
UMLS CUI-1
C0430397
UMLS CUI-2
C3854240
Urinalysis Microscopy Test
Descripción

Urinalysis Microscopy Test

Tipo de datos

integer

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

Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) section(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0587081
Serology - Screen for HIV Antibody and Hepatitis B&C
Descripción

Serology - Screen for HIV Antibody and Hepatitis B&C

Alias
UMLS CUI-1
C0036743
UMLS CUI-2
C0019682
UMLS CUI-3
C0019163
UMLS CUI-4
C0019196
Date sample taken (Serology)
Descripción

Date sample taken (Serology)

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C1302413
HIV 1&2 antibodies
Descripción

HIV 1&2 antibodies

Tipo de datos

integer

Alias
UMLS CUI [1]
C0019683
Hepatitis B surface antigen
Descripción

Hepatitis B surface antigen

Tipo de datos

integer

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Descripción

Hepatitis C antibody

Tipo de datos

integer

Alias
UMLS CUI [1]
C0201487
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Similar models

Screening - Serious Adverse Event; Local Laboratory; Urinalysis; Serology - Screen for HIV Antibody and Hepatitis B & C

1 formularios
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
Serious Adverse Event
C1519255 (UMLS CUI-1)
Did the subject experience a Serious Adverse Event during the study?
Item
Did the subject experience a Serious Adverse Event during the study?
boolean
C1519255 (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
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Clinical Chemistry Test
integer
C0525044 (UMLS CUI [1])
Clinical Chemistry Test
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
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Haematology Test
integer
C0018941 (UMLS CUI [1])
Haematology Test
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)
Haematology Test Result
Item
Haematology Test Result
text
C0018941 (UMLS CUI [1,1])
C1274040 (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])
Result of dipstick
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])
Urinalysis Test
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])
C1274040 (UMLS CUI [1,2])
Urinalysis Test Result
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])
Urinalysis Microscopy Test
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])
Item Group
Local Laboratory - Unscheduled Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C3854240 (UMLS CUI-3)
Date and time sample taken (Unscheduled Clinical Chemistry)
Item
Date and time sample taken (Unscheduled Clinical Chemistry)
datetime
C0008000 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
Item Group
Local Laboratory - Unscheduled Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C3854240 (UMLS CUI-3)
Item
Clinical Chemistry Test
integer
C0525044 (UMLS CUI [1])
Clinical Chemistry Test
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 - Unscheduled Haematology
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
C3854240 (UMLS CUI-3)
Date and time sample taken (Unscheduled Haematology)
Item
Date and time sample taken (Unscheduled Haematology)
datetime
C0018941 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C0870078 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
Item Group
Local Laboratory - Unscheduled Haematology
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
C3854240 (UMLS CUI-3)
Item
Haematology Test
integer
C0018941 (UMLS CUI [1])
Haematology Test
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)
Haematology Test Result
Item
Haematology Test Result
text
C0018941 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
Unscheduled Urinalysis - Local
C0042014 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Date and time sample taken (Unscheduled Urinalysis)
Item
Date and time sample taken (Unscheduled Urinalysis)
datetime
C0042014 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
Item
Result of dipstick
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Result of dipstick
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
Unscheduled Urinalysis - Local
C0042014 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Item
Urinalysis Test
integer
C0042014 (UMLS CUI [1])
Urinalysis Test
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])
C1274040 (UMLS CUI [1,2])
Urinalysis Test Result
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 (Unscheduled)
C0430397 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Was sedimentary microscopy performed?
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Item Group
Urinalysis - Microscopy (Unscheduled)
C0430397 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Item
Urinalysis Microscopy Test
integer
C0430397 (UMLS CUI [1])
Urinalysis Microscopy Test
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])
Item Group
Serology - Screen for HIV Antibody and Hepatitis B&C
C0036743 (UMLS CUI-1)
C0019682 (UMLS CUI-2)
C0019163 (UMLS CUI-3)
C0019196 (UMLS CUI-4)
Date sample taken (Serology)
Item
Date sample taken (Serology)
date
C0036743 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
HIV 1&2 antibodies
integer
C0019683 (UMLS CUI [1])
HIV 1&2 antibodies
Code List
HIV 1&2 antibodies
CL Item
Negative (1)
CL Item
Positive (2)
Item
Hepatitis B surface antigen
integer
C0019168 (UMLS CUI [1])
Hepatitis B surface antigen
Code List
Hepatitis B surface antigen
CL Item
Negative (1)
CL Item
Positive (2)
Item
Hepatitis C antibody
integer
C0201487 (UMLS CUI [1])
Hepatitis C antibody
Code List
Hepatitis C antibody
CL Item
Negative (1)
CL Item
Positive (2)
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