ID

29639

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 Follow-Up Part 1: Physical Examination, Vital Signs and Pedal Oedema as well as Pulmonary Function Test.

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

To request one please log in.

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

Follow-Up Part 1 - Physical Examination, Pulmonary Function Test

1 forms  
Administrative Data
Description

Administrative Data

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
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

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0518766
Planned Relative Time
Description

Planned Relative Time

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0518766
Actual Time of Vital Signs
Description

Actual Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Systolic blood pressure
Description

The subject should be in the supine position for at least 5 minutes before and during the recording.

Data type

integer

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

The subject should be in the supine position for at least 5 minutes before and during the recording.

Data type

integer

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

The subject should be in the supine position for at least 5 minutes before and during the recording.

Data type

integer

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 [1,1]
C2985720
UMLS CUI [1,2]
C0574002
Time of Assessment
Description

Hr:Min 00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0574002
Pick one.
Description

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. Note: Use the same ankle throughout the study.

Data type

integer

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

Side Ankle

Data type

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0441987
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
Hair and skin
Description

Indicate current physical findings by ticking the appropriate box below and if ABNORMAL, describe concisely (following item).

Data type

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
Hair and Skin: if abnormal, describe concisely
Description

if ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/)

Data type

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
UMLS CUI [1,3]
C1704258
Lymph nodes
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Data type

text

Alias
UMLS CUI [1]
C0024204
Lymph nodes: if abnormal, describe concisely
Description

if ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/)

Data type

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C1704258
Eyes
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Data type

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0031809
Eyes: if abnormal, describe concisely
Description

if ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/)

Data type

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C1704258
Ears, nose and throat
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Data type

text

Alias
UMLS CUI [1]
C0278350
Ears, nose and throat: if abnormal, describe concisely.
Description

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Data type

text

Alias
UMLS CUI [1,1]
C0278350
UMLS CUI [1,2]
C1704258
Breasts
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Data type

text

Alias
UMLS CUI [1]
C0199850
Breasts: if abnormal, describe concisely:
Description

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0006141
Respiratory
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Data type

text

Alias
UMLS CUI [1]
C0231832
Respiratory: if abnormal, describe concisely
Description

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Data type

text

Alias
UMLS CUI [1,1]
C0035237
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0205161
Cardiovascular
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Data type

text

Alias
UMLS CUI [1]
C3854344
Cardiovascular: if abnormal, describe concisely
Description

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Data type

text

Alias
UMLS CUI [1,1]
C3854344
UMLS CUI [1,2]
C0205161
Abdomen
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Data type

text

Alias
UMLS CUI [1]
C0562238
Abdomen: if abnormal, describe concisely
Description

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0000726
Urogenital
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Data type

text

Alias
UMLS CUI [1]
C1828035
Urogenital: if abnormal, describe concisely.
Description

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Data type

text

Alias
UMLS CUI [1,1]
C1828035
UMLS CUI [1,2]
C0205161
Pelvic
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
Pelvic: if abnormal, describe concisely.
Description

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C0205161
Rectal
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Data type

text

Alias
UMLS CUI [1]
C0199900
Rectal: if abnormal, describe concisely.
Description

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Data type

text

Alias
UMLS CUI [1,1]
C0199900
UMLS CUI [1,2]
C0205161
Musculoskeletal
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Data type

text

Alias
UMLS CUI [1]
C0475091
Musculoskeletal: if abnormal, describe concisely.
Description

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Data type

text

Alias
UMLS CUI [1,1]
C0475091
UMLS CUI [1,2]
C0205161
Neurological
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Data type

text

Alias
UMLS CUI [1]
C0027853
Neurological: if abnormal, describe concisely.
Description

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0027853
Mental Status
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278060
Mental Status: if abnormal, describe concisely.
Description

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0278060
Pulmonary function tests / FEV 1
Description

Pulmonary function tests / FEV 1

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0429706
Date of FEV1
Description

Date of FEV1

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0429706
Planned Relative Time
Description

Time relative to dosing

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0748133
Pulmonary Function Time
Description

Pulmonary Function Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0024119
FEV1 Reading 1
Description

FEV1 Reading 1

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
FEV1 Reading 2
Description

FEV1 Reading 2

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
FEV1 Reading 3
Description

FEV1 Reading 3

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
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Similar models

Follow-Up Part 1 - Physical Examination, Pulmonary Function Test

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
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
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Follow-Up (Follow-Up)
CL Item
Unscheduled (Unscheduled)
Actual Time
Item
Actual Time of Vital Signs
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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
integer
C0018810 (UMLS CUI [1])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1,1])
C0574002 (UMLS CUI [1,2])
Time of Assessment
Item
Time of Assessment
time
C0011008 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0574002 (UMLS CUI [1,3])
Item
Pick one.
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Depth of Indentation
Code List
Pick one.
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
Pick 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 Ankle
Code List
Pick the appropriate box below to indicate which ankle was assessed at this visit:
CL Item
right ankle (1)
CL Item
left ankle (2)
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Hair and skin
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
Hair and skin
Code List
Hair and skin
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Abnormal Hair and skin
Item
Hair and Skin: if abnormal, describe concisely
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Lymph nodes
text
C0024204 (UMLS CUI [1])
Lymph nodes
Code List
Lymph nodes
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal Lymph nodes
Item
Lymph nodes: if abnormal, describe concisely
text
C0024204 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Eyes
text
C0015392 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Eyes
Code List
Eyes
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal eyes
Item
Eyes: if abnormal, describe concisely
text
C0015392 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Ears, nose and throat
text
C0278350 (UMLS CUI [1])
Ears, nose and throat
Code List
Ears, nose and throat
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal Ears, nose and throat
Item
Ears, nose and throat: if abnormal, describe concisely.
text
C0278350 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Breasts
text
C0199850 (UMLS CUI [1])
Ears, nose and throat
Code List
Breasts
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Abnormal Breasts
Item
Breasts: if abnormal, describe concisely:
text
C1704258 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
Item
Respiratory
text
C0231832 (UMLS CUI [1])
Ears, nose and throat
Code List
Respiratory
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Respiratory: if abnormal, describe concisely
text
C0035237 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Ears, nose and throat
Code List
Respiratory: if abnormal, describe concisely
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Cardiovascular
text
C3854344 (UMLS CUI [1])
Ears, nose and throat
Code List
Cardiovascular
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Cardiovascular: if abnormal, describe concisely
text
C3854344 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Ears, nose and throat
Code List
Cardiovascular: if abnormal, describe concisely
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Abdomen
text
C0562238 (UMLS CUI [1])
Ears, nose and throat
Code List
Abdomen
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Abdomen: if abnormal, describe concisely
text
C1704258 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Ears, nose and throat
Code List
Abdomen: if abnormal, describe concisely
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Item
Urogenital
text
C1828035 (UMLS CUI [1])
Ears, nose and throat
Code List
Urogenital
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Abnormal urogenital
Item
Urogenital: if abnormal, describe concisely.
text
C1828035 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Item
Pelvic
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
Ears, nose and throat
Code List
Pelvic
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Abnormal Pelvic
Item
Pelvic: if abnormal, describe concisely.
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Item
Rectal
text
C0199900 (UMLS CUI [1])
Ears, nose and throat
Code List
Rectal
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Abnormal Rectal
Item
Rectal: if abnormal, describe concisely.
text
C0199900 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Item
Musculoskeletal
text
C0475091 (UMLS CUI [1])
Ears, nose and throat
Code List
Musculoskeletal
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal Musculoskeletal
Item
Musculoskeletal: if abnormal, describe concisely.
text
C0475091 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Item
Neurological
text
C0027853 (UMLS CUI [1])
Ears, nose and throat
Code List
Neurological
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal neurological
Item
Neurological: if abnormal, describe concisely.
text
C1704258 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
Item
Mental Status
text
C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Ears, nose and throat
Code List
Mental Status
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal Mental Status
Item
Mental Status: if abnormal, describe concisely.
text
C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Item Group
Pulmonary function tests / FEV 1
C0024119 (UMLS CUI-1)
C0429706 (UMLS CUI-2)
Date of FEV1
Item
Date of FEV1
date
C0011008 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Unscheduled (Unscheduled)
CL Item
Follow-Up (Follow-Up)
Pulmonary Function Time
Item
Pulmonary Function Time
time
C0040223 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
FEV1 Reading 1
Item
FEV1 Reading 1
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
FEV1 Reading 2
Item
FEV1 Reading 2
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
FEV1 Reading 3
Item
FEV1 Reading 3
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
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