ID

41122

Description

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Versions (1)
  1. 6/26/20 6/26/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 26, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

English

Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use; Serology

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Study Identifier
Description

Study Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Race
Description

Select all that apply

Data type

integer

Alias
UMLS CUI [1]
C0034510
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0012634
Diagnosis
Description

Only in the absence of a diagnosis, record the signs and symptoms on serparate lines

Data type

text

Alias
UMLS CUI [1]
C0011900
Medical Condition Status
Description

Medical Condition Status

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Alcohol intake
Description

Alcohol intake

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Description

Does the subject consume alcohol?

Data type

boolean

Alias
UMLS CUI [1]
C0001948
Average number of units of alcohol consumed per week
Description

Average number of units of alcohol consumed per week

Data type

integer

Measurement units
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per week
History of Tobacco Use
Description

History of Tobacco Use

Alias
UMLS CUI-1
C0543414
What is the subject's history of tobacco use?
Description

What is the subject's history of tobacco use?

Data type

integer

Alias
UMLS CUI [1]
C0841002
If former smoker, when did the subject last smoke?
Description

If former smoker, when did the subject last smoke?

Data type

date

Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C0037369
UMLS CUI [1,3]
C1517741
If former smoker, enter number of pack years
Description

If former smoker, enter number of pack years

Data type

integer

Measurement units
  • pack years
Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C1277691
pack years
Serology
Description

Serology

Alias
UMLS CUI-1
C0036743
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
HIV antibody
Description

HIV antibody

Data type

integer

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

Hepatitis B surface antigen

Data type

integer

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Description

Hepatitis C antibody

Data type

integer

Alias
UMLS CUI [1]
C0201487
Back to the top of the page

Similar models

Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use; Serology

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Identifier
Item
Study Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Medical Condition Status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Medical Condition Status
Code List
Medical Condition Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Alcohol intake
C0001948 (UMLS CUI-1)
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Average number of units of alcohol consumed per week
Item
Average number of units of alcohol consumed per week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
History of Tobacco Use
C0543414 (UMLS CUI-1)
Item
What is the subject's history of tobacco use?
integer
C0841002 (UMLS CUI [1])
What is the subject's history of tobacco use?
Code List
What is the subject's history of tobacco use?
CL Item
never smoked (1)
CL Item
Current smoker (2)
CL Item
Former smoker (3)
If former smoker, when did the subject last smoke?
Item
If former smoker, when did the subject last smoke?
date
C0337671 (UMLS CUI [1,1])
C0037369 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
If former smoker, enter number of pack years
Item
If former smoker, enter number of pack years
integer
C0337671 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
Item Group
Serology
C0036743 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
HIV antibody
integer
C0019683 (UMLS CUI [1])
HIV antibody
Code List
HIV antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis B surface antigen
integer
C0019168 (UMLS CUI [1])
Hepatitis B surface antigen
Code List
Hepatitis B surface antigen
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis C antibody
integer
C0201487 (UMLS CUI [1])
Hepatitis C antibody
Code List
Hepatitis C antibody
CL Item
Positive (1)
CL Item
Negative (2)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial