English

visit 1 (medical evaluation) - effect of salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 forms  
DEMOGRAPHY
Description

DEMOGRAPHY

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
MEDICAL CONDITIONS
Description

MEDICAL CONDITIONS

Alias
UMLS CUI-1
C0012634
MedDRA System Organ Class
Description

MedDRA System Organ Class

Data type

integer

Alias
UMLS CUI [1]
C2347091
Current medical condition
Description

current medical condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0012634
no medical condition
Description

medical condition

Data type

boolean

Alias
UMLS CUI [1]
C0012634
HISTORY OF TOBACCO USE
Description

HISTORY OF TOBACCO USE

Alias
UMLS CUI-1
C0543414
What is the subject’s history of tobacco use?
Description

tobacco use

Data type

integer

Alias
UMLS CUI [1]
C0543414
if former smoker, when did the subjet last smoke?
Description

last smoke

Data type

date

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0011008
Average number of cigarettes smoked per day
Description

cigarettes per day

Data type

integer

Alias
UMLS CUI [1,1]
C3694146
UMLS CUI [1,2]
C1510992
Number of years during which the subject has smoked?
Description

number of years smoking

Data type

integer

Alias
UMLS CUI [1,1]
C0037369
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0449788
number of pack years?
Description

(Average number of cigarettes smoked per day/20) x number of years smoked

Data type

integer

Alias
UMLS CUI [1,1]
C1277691
UMLS CUI [1,2]
C0449788
COPD
Description

COPD

Alias
UMLS CUI-1
C0024117
DURATION OF COPD
Description

duration of COPD

Data type

integer

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0449238
Number of exacerbations in the last 12 months that were managed without oral corticosteroids and/or antibiotics (not involving hospitalisation)
Description

number of exacerbations managed without drugs

Data type

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0013227
Number of exacerbations in the last 12 months that required oral corticosteroids and/or antibiotics (not involving hospitalisation)
Description

number of exacerbations requiring drugs

Data type

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0013227
Number of exacerbations in the last 12 months that required hopitalisation
Description

number of exacerbations requiring hospitalisation

Data type

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0019993
OROPHARYNGEAL CANDIDIASIS EXAMINATION
Description

OROPHARYNGEAL CANDIDIASIS EXAMINATION

Alias
UMLS CUI-1
C0006849
UMLS CUI-2
C0582103
Does the subject have clinical evidence of oropharyngeal candidiasis?
Description

clinical evidence of oropharyngeal candidiasis

Data type

text

Alias
UMLS CUI [1,1]
C0006849
UMLS CUI [1,2]
C3887511
Was a swab taken?
Description

Swab need only be taken if there is clinical evidence of oropharyngeal candidiasis

Data type

text

Alias
UMLS CUI [1,1]
C0006849
UMLS CUI [1,2]
C0563454
if a swab was taken, result of the swab?
Description

oropharyngeal candidiasis test result

Data type

integer

Alias
UMLS CUI [1,1]
C0006849
UMLS CUI [1,2]
C0563454
UMLS CUI [1,3]
C1274040
CHEST X-RAY
Description

CHEST X-RAY

Alias
UMLS CUI-1
C0039985
Has the subject had a chest X-ray within the last 3 months?
Description

chest X-ray within the last 3 months

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C4086725
if the patient had a chest x-ray in the last 3 months, record the date
Description

date of chest x-ray

Data type

date

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0011008
if the patient had no chest x-ray in the last 3 months, perform one and record the date
Description

date of chest x-ray

Data type

date

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0011008
Are there any chest abnormalities other than features of COPD?
Description

Review chest X-ray (performed within the last 3 months or performed at Visit 1)

Data type

text

Alias
UMLS CUI [1]
C0497258
MODIFIED MEDICAL RESEARCH COUNCIL DYSPNOEA SCALE
Description

MODIFIED MEDICAL RESEARCH COUNCIL DYSPNOEA SCALE

Alias
UMLS CUI-1
C3826977
Which ONE of these situations best applies to the subject?
Description

dyspnoea status

Data type

integer

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C0449438
12-LEAD ECG
Description

12-LEAD ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Description

date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
Result of the ECG
Description

result of the ECG

Data type

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0456984
PULMONARY FUNCTION TESTING
Description

PULMONARY FUNCTION TESTING

Alias
UMLS CUI-1
C0024119
Did the subject take any bronchodilators prior to these lung function measurements?
Description

use of bronchodilatators before lung function measurement

Data type

text

Alias
UMLS CUI [1,1]
C0006280
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0024119
pulmonary funtion testing: FEV1
Description

pulmonary funtion testing: FEV1

Alias
UMLS CUI-1
C0748133
Time of Assessment PreVENTOLIN
Description

time of assessment before Ventolin

Data type

time

Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0220825
Actual Measurement PreVENTOLIN
Description

Actual Measurement PreVENTOLIN = A

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0242485
L
Predicted Normal
Description

Predicted Normal= B

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0205307
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0802965
UMLS CUI [1,4]
C0024119
L
% Predicted Normal
Description

% Predicted Normal= (C/B)x100 C= Actual Measurement 30 minutes PostVENTOLIN B= Predicted Normal

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C2239179
%
Actual Measurement 30 minutes PostVENTOLIN
Description

Actual Measurement 30 minutes PostVENTOLIN= C

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C1442458
L
% Reversibility
Description

% Reversibility= ((C-A)/B) x100 Actual Measurement PreVENTOLIN = A Predicted Normal= B Actual Measurement 30 minutes PostVENTOLIN= C

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C3830088
%
pulmonary function testing: FVC
Description

pulmonary function testing: FVC

Alias
UMLS CUI-1
C3714541
Actual Measurement PreVENTOLIN
Description

Actual Measurement PreVENTOLIN = A

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0242485
L
Actual Measurement 30 minutes PostVENTOLIN
Description

Actual Measurement 30 minutes PostVENTOLIN= C

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C1442458
L
pulmonary function testing: FEV1 /FVC ratio
Description

pulmonary function testing: FEV1 /FVC ratio

Alias
UMLS CUI-1
C0429745
Actual Measurement PreVENTOLIN
Description

Actual Measurement PreVENTOLIN = A

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0242485
L
Actual Measurement 30 minutes PostVENTOLIN
Description

Actual Measurement 30 minutes PostVENTOLIN= C

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C1442458
L
FAT FREE MASS
Description

FAT FREE MASS

Alias
UMLS CUI-1
C0424679
Serial number
Description

serial number

Data type

integer

Alias
UMLS CUI [1]
C2348188
Test number
Description

testing number

Data type

integer

Alias
UMLS CUI [1,1]
C0039593
UMLS CUI [1,2]
C0237753
Subject’s height at time of measurement
Description

height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Subject’s weight at time of measurement
Description

weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Fat Free Mass (Lean Muscle Mass including Muscle, Water, and Bone)
Description

fat free mass

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0424679
kg
Impedance (The resistance)
Description

impedance

Data type

integer

Measurement units
  • ohm
Alias
UMLS CUI [1]
C0162537
ohm
CENTRAL LABORATORY - BLOOD
Description

CENTRAL LABORATORY - BLOOD

Alias
UMLS CUI-1
C0018941
Date sample taken
Description

blood sample taken

Data type

date

Alias
UMLS CUI [1]
C1277698
ST. GEORGE’S RESPIRATORY QUESTIONNAIRE
Description

ST. GEORGE’S RESPIRATORY QUESTIONNAIRE

Alias
UMLS CUI-1
C0451500
Confirm the SGRQ has been completed by the subject
Description

St George's hospital respiratory questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C0451500
BASELINE DYSPNOEA INDEX (BDI)
Description

BASELINE DYSPNOEA INDEX (BDI)

Alias
UMLS CUI-1
C1511069
Confirm the BDI instrument has been signed and dated
Description

BDI instrument signed and dated

Data type

boolean

Alias
UMLS CUI [1,1]
C1511069
UMLS CUI [1,2]
C1519316
UMLS CUI [1,3]
C0011008
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Similar models

visit 1 (medical evaluation) - effect of salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
DEMOGRAPHY
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Female (F)
CL Item
Male (M)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Arabic/North African (2)
(Comment:en)
CL Item
Black (3)
(Comment:en)
CL Item
East & South East Asian (4)
(Comment:en)
CL Item
other (z)
(Comment:en)
CL Item
South Asian (6)
(Comment:en)
CL Item
White/Caucasian (7)
(Comment:en)
Item Group
MEDICAL CONDITIONS
C0012634 (UMLS CUI-1)
Item
MedDRA System Organ Class
integer
C2347091 (UMLS CUI [1])
MedDRA System Organ Class
Code List
MedDRA System Organ Class
CL Item
Blood and lymphatic system disorders (1)
CL Item
Cardiac disorders (2)
CL Item
Ear and labyrinth disorders (3)
CL Item
Endocrine disorders (4)
CL Item
Eye disorders (5)
CL Item
Gastrointestinal disorders (6)
CL Item
Hepatobiliary disorders (7)
CL Item
Immune system disorders (8)
CL Item
Metabolism and nutrition disorders (9)
CL Item
Musculoskeletal and connective tissue disorders (10)
CL Item
Neoplasms benign, malignant and unspecified (including cysts and polyps) (11)
CL Item
Nervous system disorders (12)
CL Item
Psychiatric disorders (13)
CL Item
Renal and urinary disorders (14)
CL Item
Reproductive system and breast disorders (15)
CL Item
Respiratory, thoracic and mediastinal disorders (16)
CL Item
Skin and subcutaneous tissue disorders (17)
CL Item
Vascular disorders (18)
CL Item
Infections and infestations (19)
CL Item
Congenital, familial and genetic disorders (20)
current medical condition
Item
Current medical condition
boolean
C0521116 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
medical condition
Item
no medical condition
boolean
C0012634 (UMLS CUI [1])
Item Group
HISTORY OF TOBACCO USE
C0543414 (UMLS CUI-1)
Item
What is the subject’s history of tobacco use?
integer
C0543414 (UMLS CUI [1])
tobacco use
Code List
What is the subject’s history of tobacco use?
CL Item
current smoker (2)
(Comment:en)
CL Item
former smoker (3)
(Comment:en)
last smoke
Item
if former smoker, when did the subjet last smoke?
date
C0543414 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
cigarettes per day
Item
Average number of cigarettes smoked per day
integer
C3694146 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
number of years smoking
Item
Number of years during which the subject has smoked?
integer
C0037369 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
number of pack years
Item
number of pack years?
integer
C1277691 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
COPD
C0024117 (UMLS CUI-1)
Item
DURATION OF COPD
integer
C0024117 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
duration of COPD
Code List
DURATION OF COPD
CL Item
< 5 years  (9)
CL Item
≥ 5 years to < 10 years (11)
CL Item
≥ 10 years to < 15 years (13)
CL Item
≥ 15 years to < 20 years (15)
CL Item
≥ 20 years to < 25 years  (17)
CL Item
≥ 25 years (18)
number of exacerbations managed without drugs
Item
Number of exacerbations in the last 12 months that were managed without oral corticosteroids and/or antibiotics (not involving hospitalisation)
integer
C0740304 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
number of exacerbations requiring drugs
Item
Number of exacerbations in the last 12 months that required oral corticosteroids and/or antibiotics (not involving hospitalisation)
integer
C0740304 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
number of exacerbations requiring hospitalisation
Item
Number of exacerbations in the last 12 months that required hopitalisation
integer
C0740304 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Item Group
OROPHARYNGEAL CANDIDIASIS EXAMINATION
C0006849 (UMLS CUI-1)
C0582103 (UMLS CUI-2)
Item
Does the subject have clinical evidence of oropharyngeal candidiasis?
text
C0006849 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
clinical evidence of oropharyngeal candidiasis
Code List
Does the subject have clinical evidence of oropharyngeal candidiasis?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was a swab taken?
text
C0006849 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
taking of a swab
Code List
Was a swab taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
if a swab was taken, result of the swab?
integer
C0006849 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
oropharyngeal candidiasis test result
Code List
if a swab was taken, result of the swab?
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not available (4)
Item Group
CHEST X-RAY
C0039985 (UMLS CUI-1)
Item
Has the subject had a chest X-ray within the last 3 months?
text
C0039985 (UMLS CUI [1,1])
C4086725 (UMLS CUI [1,2])
chest X-ray within the last 3 months
Code List
Has the subject had a chest X-ray within the last 3 months?
CL Item
Yes (Y)
CL Item
No (N)
date of chest x-ray
Item
if the patient had a chest x-ray in the last 3 months, record the date
date
C0039985 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
date of chest x-ray
Item
if the patient had no chest x-ray in the last 3 months, perform one and record the date
date
C0039985 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Are there any chest abnormalities other than features of COPD?
text
C0497258 (UMLS CUI [1])
chest abnormalities
Code List
Are there any chest abnormalities other than features of COPD?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
MODIFIED MEDICAL RESEARCH COUNCIL DYSPNOEA SCALE
C3826977 (UMLS CUI-1)
Item
Which ONE of these situations best applies to the subject?
integer
C0013404 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
dyspnoea status
Code List
Which ONE of these situations best applies to the subject?
CL Item
Not troubled with breathlessness except with strenuous exercise (0)
CL Item
Troubled by shortness of breath when hurrying on the level or walking up a slight hill (1)
CL Item
Walks slower than people of the same age on the level because of breathlessness or has to stop for (2)
CL Item
breath when walking at own pace on the level (4)
CL Item
Stops to breathe after walking about 100 yards (100 meters) or after a few minutes on the level (3)
CL Item
Too breathless to leave the house or breathless when dressing or undressing (4)
Item Group
12-LEAD ECG
C0430456 (UMLS CUI-1)
date of ECG
Item
Date of ECG
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
Item Group
PULMONARY FUNCTION TESTING
C0024119 (UMLS CUI-1)
Item
Did the subject take any bronchodilators prior to these lung function measurements?
text
C0006280 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,3])
use of bronchodilatators before lung function measurement
Code List
Did the subject take any bronchodilators prior to these lung function measurements?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
pulmonary funtion testing: FEV1
C0748133 (UMLS CUI-1)
time of assessment before Ventolin
Item
Time of Assessment PreVENTOLIN
time
C0033744 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
measurement before Ventolin
Item
Actual Measurement PreVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
predicted normal FEV1
Item
Predicted Normal
float
C0205307 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0802965 (UMLS CUI [1,3])
C0024119 (UMLS CUI [1,4])
percent predicted normal
Item
% Predicted Normal
float
C2239179 (UMLS CUI [1])
measurement 30 minutes after Ventolin
Item
Actual Measurement 30 minutes PostVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
FEV1 Reversibility
Item
% Reversibility
integer
C3830088 (UMLS CUI [1])
Item Group
pulmonary function testing: FVC
C3714541 (UMLS CUI-1)
measurement before Ventolin
Item
Actual Measurement PreVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
measurement 30 minutes after Ventolin
Item
Actual Measurement 30 minutes PostVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
Item Group
pulmonary function testing: FEV1 /FVC ratio
C0429745 (UMLS CUI-1)
measurement before Ventolin
Item
Actual Measurement PreVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
measurement 30 minutes after Ventolin
Item
Actual Measurement 30 minutes PostVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
Item Group
FAT FREE MASS
C0424679 (UMLS CUI-1)
serial number
Item
Serial number
integer
C2348188 (UMLS CUI [1])
testing number
Item
Test number
integer
C0039593 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
height
Item
Subject’s height at time of measurement
integer
C0005890 (UMLS CUI [1])
weight
Item
Subject’s weight at time of measurement
float
C0005910 (UMLS CUI [1])
fat free mass
Item
Fat Free Mass (Lean Muscle Mass including Muscle, Water, and Bone)
float
C0424679 (UMLS CUI [1])
impedance
Item
Impedance (The resistance)
integer
C0162537 (UMLS CUI [1])
Item Group
CENTRAL LABORATORY - BLOOD
C0018941 (UMLS CUI-1)
blood sample taken
Item
Date sample taken
date
C1277698 (UMLS CUI [1])
Item Group
ST. GEORGE’S RESPIRATORY QUESTIONNAIRE
C0451500 (UMLS CUI-1)
St George's hospital respiratory questionnaire
Item
Confirm the SGRQ has been completed by the subject
boolean
C0451500 (UMLS CUI [1])
Item Group
BASELINE DYSPNOEA INDEX (BDI)
C1511069 (UMLS CUI-1)
BDI instrument signed and dated
Item
Confirm the BDI instrument has been signed and dated
boolean
C1511069 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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