ID

41150

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. 7/1/20 7/1/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 1, 2020

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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

Vital Signs

1 forms  
  1. StudyEvent: ODM
    1. Vital Signs
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Vital Signs (BMI Calculation) (Screening)
Description

Vital Signs (BMI Calculation) (Screening)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1305855
UMLS CUI-3
C0220908
Does the subject have a body mass index within the range 18.0 to 34.9 kg/m2?
Description

Does the subject have a body mass index within the range 18.0 to 34.9 kg/m2?

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Vital Signs (Mean Calculation) (Screening)
Description

Vital Signs (Mean Calculation) (Screening)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0220908
Planned Relative Time
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301732
Systolic Blood Pressure Supine
Description

Systolic Blood Pressure Supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mm[Hg]
Diastolic Blood Pressure Supine
Description

Diastolic Blood Pressure Supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mm[Hg]
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Vital Signs (Screening)
Description

Vital Signs (Screening)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0220908
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Body mass index

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Vital Signs (Screening)
Description

Vital Signs (Screening)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0220908
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301732
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure Supine
Description

Systolic Blood Pressure Supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mm[Hg]
Diastolic Blood Pressure Supine
Description

Diastolic Blood Pressure Supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mm[Hg]
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Vital Signs (Treatment Period 1 - 4)
Description

Vital Signs (Treatment Period 1 - 4)

Alias
UMLS CUI-1
C0518766
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301732
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure Supine
Description

Systolic Blood Pressure Supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mm[Hg]
Diastolic Blood Pressure Supine
Description

Diastolic Blood Pressure Supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mm[Hg]
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Vital Signs (Treatment Period 5)
Description

Vital Signs (Treatment Period 5)

Alias
UMLS CUI-1
C0518766
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301732
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure Supine
Description

Systolic Blood Pressure Supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mm[Hg]
Diastolic Blood Pressure Supine
Description

Diastolic Blood Pressure Supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mm[Hg]
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Vital Signs (Follow-Up)
Description

Vital Signs (Follow-Up)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1522577
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301732
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure Supine
Description

Systolic Blood Pressure Supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mm[Hg]
Diastolic Blood Pressure Supine
Description

Diastolic Blood Pressure Supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mm[Hg]
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
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Similar models

Vital Signs

1 forms
  1. StudyEvent: ODM
    1. Vital Signs
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])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs (BMI Calculation) (Screening)
C0518766 (UMLS CUI-1)
C1305855 (UMLS CUI-2)
C0220908 (UMLS CUI-3)
Does the subject have a body mass index within the range 18.0 to 34.9 kg/m2?
Item
Does the subject have a body mass index within the range 18.0 to 34.9 kg/m2?
boolean
C1305855 (UMLS CUI [1])
Item Group
Vital Signs (Mean Calculation) (Screening)
C0518766 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Screening (1)
CL Item
Mean (2)
Systolic Blood Pressure Supine
Item
Systolic Blood Pressure Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure Supine
Item
Diastolic Blood Pressure Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Vital Signs (Screening)
C0518766 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Item Group
Vital Signs (Screening)
C0518766 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Screening (1)
CL Item
Unscheduled (2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure Supine
Item
Systolic Blood Pressure Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure Supine
Item
Diastolic Blood Pressure Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Vital Signs (Treatment Period 1 - 4)
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
15 mins (2)
CL Item
45 mins (3)
CL Item
1.5 hrs (4)
CL Item
4 hrs (5)
CL Item
8 hrs (6)
CL Item
24 hrs (7)
CL Item
Unscheduled (8)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure Supine
Item
Systolic Blood Pressure Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure Supine
Item
Diastolic Blood Pressure Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Vital Signs (Treatment Period 5)
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose  (1)
CL Item
15 mins  (2)
CL Item
45 mins  (3)
CL Item
1.5 hrs  (4)
CL Item
4 hrs  (5)
CL Item
8 hrs  (6)
CL Item
24 hrs  (7)
CL Item
48 hrs (8)
CL Item
Unscheduled (9)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure Supine
Item
Systolic Blood Pressure Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure Supine
Item
Diastolic Blood Pressure Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Vital Signs (Follow-Up)
C0518766 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Follow-up (1)
CL Item
Unscheduled (2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure Supine
Item
Systolic Blood Pressure Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure Supine
Item
Diastolic Blood Pressure Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
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