ID

41486

Description

Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Screen Failure) is to be filled out at the Screening (Visit 1).

Link

https://clinicaltrials.gov/ct2/show/NCT00784550

Keywords

Versions (1)
  1. 10/27/20 10/27/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 27, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

English

Screen Failure

1 forms  
  1. StudyEvent: ODM
    1. Screen Failure
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit/assessment
Description

Date of visit/assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Subject identification number
Description

Subject identification number

Data type

text

Alias
UMLS CUI [1]
C2348585
Screen failure
Description

Screen failure

Alias
UMLS CUI-1
C1710476
Was this subject a screen failure?
Description

Was this subject a screen failure?

Data type

text

Alias
UMLS CUI [1]
C1710476
If yes, check primary reason
Description

Screen failure primary reason

Data type

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
If the primary reason for screen failure is Investigator discretion, please specify
Description

Primary reason for screen failure: Investigator discretion

Data type

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0008961
UMLS CUI [1,4]
C0022423
Back to the top of the page

Similar models

Screen Failure

1 forms
  1. StudyEvent: ODM
    1. Screen Failure
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Subject identification number
Item
Subject identification number
text
C2348585 (UMLS CUI [1])
Item Group
Screen failure
C1710476 (UMLS CUI-1)
Item
Was this subject a screen failure?
text
C1710476 (UMLS CUI [1])
Was this subject a screen failure?
Code List
Was this subject a screen failure?
CL Item
No (N)
CL Item
Yes (Y)
Item
If yes, check primary reason
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Screen failure primary reason
Code List
If yes, check primary reason
CL Item
Did not meet the inclusion/exclusion criteria (F01)
CL Item
Adverse Event (unspecified) (F02)
CL Item
Protocol deviation (unspecified) (F04)
CL Item
Study closed/terminated (unspecified) (F06)
CL Item
Lost to follow up (unspecified) (F07)
CL Item
Investigator discretion, specify (F08)
CL Item
Withdrew consent (unspecified) (F09)
Primary reason for screen failure: Investigator discretion
Item
If the primary reason for screen failure is Investigator discretion, please specify
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial