ID

23000

Descripción

Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

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Versiones (1)
  1. 19/6/17 19/6/17 -
Subido en

19 de junio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Repeat (Unscheduled) - GSK Milveterol COPD 100527

Inglés

Repeat (Unscheduled) - GSK Milveterol COPD 100527

1 formularios  
Hematology Data (Unscheduled)
Descripción

Hematology Data (Unscheduled)

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C3854240
Lab code
Descripción

Lab code

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Date hematology sample taken
Descripción

Date hematology sample taken

Tipo de datos

date

Unidades de medida
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0474523
dd.mm.yyyy
Time of sample
Descripción

Time of blood sample

Tipo de datos

time

Unidades de medida
  • hh:mm
Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0040223
hh:mm
Were there any clinically significant hematology abnormalities?
Descripción

Hematology abnormality

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0850715
UMLS CUI [1,2]
C2985739
Hematology test
Descripción

Hematology test

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0332307
Hematology test result
Descripción

Hematology test result

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0587081
lf clinically significant, record primary reason for the clinically significant abnormality:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Clinical Chemistry Data (Unscheduled)
Descripción

Clinical Chemistry Data (Unscheduled)

Alias
UMLS CUI-1
C2347783
UMLS CUI-2
C3854240
Lab code
Descripción

Lab code

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Date clinical chemistry sample taken
Descripción

Date clinical chemistry sample taken

Tipo de datos

date

Unidades de medida
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0008000
dd.mm.yyyy
Time of sample
Descripción

Time of sample

Tipo de datos

time

Unidades de medida
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0008000
hh:mm
Were there any clinically significant clinical chemistry abnormalities?
Descripción

clinically significant clinical chemistry abnormalities

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1704258
Clinical chemistry test
Descripción

Clinical chemistry test

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0525044
UMLS CUI [1,2]
C0332307
Clinical chemistry test result
Descripción

Clinical chemistry test result

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0587081
lf clinically significant, record primary reason for the clinically significant abnormality:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Urinalysis (Unscheduled)
Descripción

Urinalysis (Unscheduled)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C3854240
Lab code
Descripción

Lab code

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Date sample taken
Descripción

Date sample taken

Tipo de datos

date

Unidades de medida
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0042036
dd.mm.yyyy
Time of sample
Descripción

Time sample taken

Tipo de datos

time

Unidades de medida
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0042036
hh:mm
Were there any clinically significant urinalysis abnormalities?
Descripción

clinically significant urinalysis abnormalities

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C1704258
Dipstick test
Descripción

Urinalysis dipstick

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0332307
Dipstick test result
Descripción

Dipstick test result

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0587081
lf clinically significant, record primary reason for the clinically significant abnormality:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Sedimentary microscopy test (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
Descripción

Sedimentary microscopy test

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2700128
UMLS CUI [1,2]
C0332307
Sedimentary microscopy test result
Descripción

Sedimentary microscopy test result

Tipo de datos

float

Alias
UMLS CUI [1,1]
C2700128
UMLS CUI [1,2]
C0587081
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
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Similar models

Repeat (Unscheduled) - GSK Milveterol COPD 100527

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Hematology Data (Unscheduled)
C0474523 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Lab code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date hematology sample taken
Item
Date hematology sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,3])
Time of blood sample
Item
Time of sample
time
C0200345 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Hematology abnormality
Item
Were there any clinically significant hematology abnormalities?
boolean
C0850715 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Hematology test
integer
C0018941 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Hematology test
Code List
Hematology test
CL Item
Hemoglobin (1)
CL Item
Hematocrit (PCV) (2)
CL Item
RBC (3)
CL Item
MCV (4)
CL Item
MCH (5)
CL Item
MCHC (6)
CL Item
Platelets (7)
CL Item
Total WBC (8)
CL Item
Neutrophils (9)
CL Item
Lymphocytes (10)
CL Item
Monocytes (11)
CL Item
Eosinophils (12)
CL Item
Basophils (13)
Hematology test result
Item
Hematology test result
float
C0018941 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
clinically significant abnormality reason
Code List
lf clinically significant, record primary reason for the clinically significant abnormality:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item Group
Clinical Chemistry Data (Unscheduled)
C2347783 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Lab code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date clinical chemistry sample taken
Item
Date clinical chemistry sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
clinically significant clinical chemistry abnormalities
Item
Were there any clinically significant clinical chemistry abnormalities?
boolean
C2985739 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Clinical chemistry test
integer
C0525044 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Clinical chemistry test
Code List
Clinical chemistry test
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Calcium (4)
CL Item
Glucose (5)
CL Item
CPK (6)
CL Item
Creatinine (7)
CL Item
Urea (8)
CL Item
Total bilirubin (9)
CL Item
Alkaline Phosphatase (10)
CL Item
AST (SGOT) (11)
CL Item
ALT (SGPT) (12)
CL Item
GGT (13)
CL Item
LOH (14)
CL Item
CK-MB (15)
CL Item
Troponin T (16)
Clinical chemistry test result
Item
Clinical chemistry test result
float
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
clinically significant abnormality reason
Code List
lf clinically significant, record primary reason for the clinically significant abnormality:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item Group
Urinalysis (Unscheduled)
C0042014 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Lab code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
Time sample taken
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
clinically significant urinalysis abnormalities
Item
Were there any clinically significant urinalysis abnormalities?
boolean
C0042014 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Dipstick test
integer
C0430370 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Urinalysis dipstick
Code List
Dipstick test
CL Item
Protein (1)
CL Item
Blood (2)
CL Item
Ketones (3)
CL Item
Glucose (4)
CL Item
Bilirubin (5)
CL Item
Leucocytes (6)
Item
Dipstick test result
integer
C0430370 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
undefined item
Code List
Dipstick test result
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ (3)
CL Item
++ (4)
CL Item
+++ (5)
CL Item
++++ (6)
Item
lf clinically significant, record primary reason for the clinically significant abnormality:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
clinically significant abnormality reason
Code List
lf clinically significant, record primary reason for the clinically significant abnormality:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item
Sedimentary microscopy test (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
integer
C2700128 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Sedimentary microscopy test
Code List
Sedimentary microscopy test (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Sedimentary microscopy test result
Item
Sedimentary microscopy test result
float
C2700128 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
clinically significant abnormality reason
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
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