ID

29662

Description

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Physical Examination: Vital Signs, pedal oedema. Time: Treatment Period 1, Day 28, pre-dose.

Link

https://clinicaltrials.gov/ct2/show/NCT00318630

Keywords

Versions (1)
  1. 4/10/18 4/10/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 10, 2018

DOI

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License

Creative Commons BY-NC 3.0
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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

English

Physical examination - Treatment Period 1, Day 28, Pre-dose

1 forms  
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Date
Description

Day Month Year e.g., 01 JAN 03

Data type

date

Alias
UMLS CUI [1]
C0011008
Planned relative Time
Description

e.g. 15 min

Data type

text

Alias
UMLS CUI [1]
C0439564
Actual Time
Description

Hr : Min (00:00 - 23:59) e.g. 13:02

Data type

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Description

Supine. The subject should be in the supine position for at least 5 minutes before and during the recording. At least three consecutive readings more than 1 minute apart will be recorded. Systolic e.g. 110

Data type

integer

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

Supine. The subject should be in the supine position for at least 5 minutes before and during the recording. At least three consecutive readings more than 1 minute apart will be recorded. Diastolic e.g. 80

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart rate
Description

e.g., 75

Data type

text

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Pedal Oedema
Description

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Time of Assessment
Description

Hr : Min (00:00 - 23:59)

Data type

time

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0040223
Press firmly with thumb anterior to the ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
Description

Note: Use the same ankle throughout the study.

Data type

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0205125
Mark the appropriate box below to indicate which ankle was assessed at this visit.
Description

Side of assessed ankle

Data type

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0441987
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Similar models

Physical examination - Treatment Period 1, Day 28, Pre-dose

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Planned relative Time
text
C0439564 (UMLS CUI [1])
Planned relative Time
Code List
Planned relative Time
CL Item
pre-dose (pre-dose)
CL Item
unscheduled (unscheduled)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
text
C0018810 (UMLS CUI [1])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Time of Assessment
Item
Time of Assessment
time
C1516048 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Press firmly with thumb anterior to the ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Depth of Indentation
Code List
Press firmly with thumb anterior to the ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
CL Item
<1 mm (1)
CL Item
1-2 mm (2)
CL Item
3-5 mm (3)
CL Item
6-10 mm (4)
CL Item
>10 mm (5)
Item
Mark the appropriate box below to indicate which ankle was assessed at this visit.
integer
C0574002 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Side of assessed ankle
Code List
Mark the appropriate box below to indicate which ankle was assessed at this visit.
CL Item
right ankle (1)
CL Item
left ankle (2)
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