ID

41157

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. 7/2/20 7/2/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 2, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

English

Physical Examination

1 forms  
  1. StudyEvent: ODM
    1. Physical Examination
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Physical Examination
Description

Physical Examination

Data type

integer

Alias
UMLS CUI [1]
C0031809
Physical Examination Finding
Description

If ABNORMAL, describe concisely

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
Physical examination abnormal finding description
Description

Physical examination abnormal finding description

Data type

text

Alias
UMLS CUI [1,1]
C2826636
UMLS CUI [1,2]
C0678257
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Similar models

Physical Examination

1 forms
  1. StudyEvent: ODM
    1. Physical Examination
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Physical Examination
integer
C0031809 (UMLS CUI [1])
Physical Examination
Code List
Physical Examination
CL Item
Hair and skin (1)
CL Item
Lymph nodes (2)
CL Item
Eyes (3)
CL Item
Ears, Nose, Throat (4)
CL Item
Breasts (5)
CL Item
Respiratory (6)
CL Item
Cardiovascular (7)
CL Item
Abdomen (8)
CL Item
Urogenital (9)
CL Item
Pelvic (10)
CL Item
Rectal (11)
CL Item
Musculoskeletal (12)
CL Item
Neurological (13)
CL Item
Mental Status (14)
Item
Physical Examination Finding
integer
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Physical Examination Finding
Code List
Physical Examination Finding
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Physical examination abnormal finding description
Item
Physical examination abnormal finding description
text
C2826636 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
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