ID

24606

Description

Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

Versions (2)
  1. 8/6/17 8/6/17 -
  2. 8/8/17 8/8/17 -
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August 8, 2017

DOI

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License

Creative Commons BY-NC 3.0
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unscheduled clinical contacts salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

English

unscheduled clinical contacts salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

subject identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
UNSCHEDULED / EMERGENCY CLINIC CONTACTS
Description

UNSCHEDULED / EMERGENCY CLINIC CONTACTS

Alias
UMLS CUI-1
C1552423
Did the subject make any unscheduled emergency contact with the clinic during the study?
Description

unscheduled emergency clinic contact

Data type

text

Alias
UMLS CUI [1]
C1552423
emergency clinic contact documentation
Description

emergency clinic contact documentation

Alias
UMLS CUI-1
C1552423
Date
Description

date of emergency clinic contact

Data type

date

Alias
UMLS CUI [1,1]
C1552423
UMLS CUI [1,2]
C1552423
Type of contact
Description

type of contact

Data type

text

Alias
UMLS CUI [1]
C0332158
Reason For Contact
Description

reason for contact

Data type

text

Alias
UMLS CUI [1]
C1547629
Subject Withdrawn?
Description

withdrawal of subject

Data type

text

Alias
UMLS CUI [1]
C2349954
UNSCHEDULED COPD RELATED HEALTHCARE CONTACTS
Description

UNSCHEDULED COPD RELATED HEALTHCARE CONTACTS

Alias
UMLS CUI-1
C0086388
UMLS CUI-2
C3854240
UMLS CUI-3
C0024117
Date of Contact
Description

date of contact

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332158
Contact Method/Treatment Site: Number of Telephone Calls
Description

If none, enter 0 [zero].

Data type

integer

Alias
UMLS CUI [1,1]
C0302186
UMLS CUI [1,2]
C0449788
Contact Method/Treatment Site: Number of Home Visits at Day
Description

If none, enter 0 [zero].

Data type

integer

Alias
UMLS CUI [1,1]
C0020043
UMLS CUI [1,2]
C0449788
UMLS CUI [2]
C0439228
Contact Method/Treatment Site: Number of Home Visits at Night
Description

If none, enter 0 [zero].

Data type

integer

Alias
UMLS CUI [1,1]
C0020043
UMLS CUI [1,2]
C0449788
UMLS CUI [2]
C0240526
Contact Method/Treatment Site: Number of Physician Office/Clinic Visits
Description

If none, enter 0 [zero].

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0031834
UMLS CUI [2,1]
C0449788
UMLS CUI [2,2]
C0008952
Contact Method/Treatment Site: Number of Urgent Care/Outpatient Clinic Visits
Description

If none, enter 0 [zero].

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1551285
UMLS CUI [1,3]
C0008952
UMLS CUI [2,1]
C0449788
UMLS CUI [2,2]
C0029921
UMLS CUI [2,3]
C0008952
Contact Method/Treatment Site: Number of Emergency Room Visits
Description

If none, enter 0 [zero].

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C2114437
Contact Method/Treatment Site: Inpatient Hospitalisation (Number of Days): ICU
Description

If none, enter 0 [zero].

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0420496
UMLS CUI [1,2]
C0021708
days
Contact Method/Treatment Site: Inpatient Hospitalisation (Number of Days): General Ward
Description

If none, enter 0 [zero].

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0043030
UMLS CUI [1,2]
C0019993
days
Was this contact due to an exacerbation?
Description

health care consultation due to exacerbation

Data type

text

Alias
UMLS CUI [1,1]
C0086388
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0235874
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Similar models

unscheduled clinical contacts salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

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
integer
C2348585 (UMLS CUI [1])
Item Group
UNSCHEDULED / EMERGENCY CLINIC CONTACTS
C1552423 (UMLS CUI-1)
Item
Did the subject make any unscheduled emergency contact with the clinic during the study?
text
C1552423 (UMLS CUI [1])
unscheduled emergency clinic contact
Code List
Did the subject make any unscheduled emergency contact with the clinic during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
emergency clinic contact documentation
C1552423 (UMLS CUI-1)
date of emergency clinic contact
Item
Date
date
C1552423 (UMLS CUI [1,1])
C1552423 (UMLS CUI [1,2])
Item
Type of contact
text
C0332158 (UMLS CUI [1])
type of contact
Code List
Type of contact
CL Item
visit (V)
CL Item
telephone (T)
reason for contact
Item
Reason For Contact
text
C1547629 (UMLS CUI [1])
Item
Subject Withdrawn?
text
C2349954 (UMLS CUI [1])
withdrawal of subject
Code List
Subject Withdrawn?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
UNSCHEDULED COPD RELATED HEALTHCARE CONTACTS
C0086388 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0024117 (UMLS CUI-3)
date of contact
Item
Date of Contact
date
C0011008 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
number of telephone calls
Item
Contact Method/Treatment Site: Number of Telephone Calls
integer
C0302186 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
number of home visits at day
Item
Contact Method/Treatment Site: Number of Home Visits at Day
integer
C0020043 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0439228 (UMLS CUI [2])
number of home visits at night
Item
Contact Method/Treatment Site: Number of Home Visits at Night
integer
C0020043 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0240526 (UMLS CUI [2])
number of physician office/ clinic visits
Item
Contact Method/Treatment Site: Number of Physician Office/Clinic Visits
integer
C0449788 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0031834 (UMLS CUI [1,3])
C0449788 (UMLS CUI [2,1])
C0008952 (UMLS CUI [2,2])
number of urgent care/ outpatient clinic visits
Item
Contact Method/Treatment Site: Number of Urgent Care/Outpatient Clinic Visits
integer
C0449788 (UMLS CUI [1,1])
C1551285 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,3])
C0449788 (UMLS CUI [2,1])
C0029921 (UMLS CUI [2,2])
C0008952 (UMLS CUI [2,3])
number of emergency room visits
Item
Contact Method/Treatment Site: Number of Emergency Room Visits
integer
C0449788 (UMLS CUI [1,1])
C2114437 (UMLS CUI [1,2])
duration of inpatient stay on ICU
Item
Contact Method/Treatment Site: Inpatient Hospitalisation (Number of Days): ICU
integer
C0420496 (UMLS CUI [1,1])
C0021708 (UMLS CUI [1,2])
duration of inpatient stay on general ward
Item
Contact Method/Treatment Site: Inpatient Hospitalisation (Number of Days): General Ward
integer
C0043030 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Item
Was this contact due to an exacerbation?
text
C0086388 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0235874 (UMLS CUI [1,3])
undefined item
Code List
Was this contact due to an exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
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