ID

29639

Beschreibung

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

Stichworte

Versionen (1)
  1. 10.04.18 10.04.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. April 2018

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Date
Beschreibung

Date

Datentyp

date

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

Planned Relative Time

Datentyp

text

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

Actual Time

Datentyp

time

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

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

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Diastolic Blood Pressure
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart Rate
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Pedal Oedema
Beschreibung

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

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

Hr:Min 00:00-23:59

Datentyp

time

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

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.

Datentyp

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:
Beschreibung

Side Ankle

Datentyp

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0441987
Physical examination
Beschreibung

Physical examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Hair and skin
Beschreibung

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

Pulmonary function tests / FEV 1

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

Date of FEV1

Datentyp

date

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

Time relative to dosing

Datentyp

text

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

Pulmonary Function Time

Datentyp

time

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

FEV1 Reading 1

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
FEV1 Reading 2
Beschreibung

FEV1 Reading 2

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
FEV1 Reading 3
Beschreibung

FEV1 Reading 3

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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