ID
39780
Description
Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Status of treatment Blind, the Study conclusion and the Pregnancy information form. It has to be filled in for follow-up.
Link
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Keywords
Versions (2)
- 2/19/20 2/19/20 -
- 2/24/20 2/24/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 19, 2020
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
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.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Treatment Blind, Study conclusion, Pregnancy information
- StudyEvent: ODM
Description
Status of treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Description
If you tick yes, please fill in the following items, complete the Adverse Event form and/or Investigational Product forms as appropriate.
Data type
text
Alias
- UMLS CUI [1]
- C3897431
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0040223
Description
Reason blind broken
Data type
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Description
Other Reason blind broken
Data type
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
Description
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0805839
Description
If you tick yes, please complete details in the following items.
Data type
text
Alias
- UMLS CUI [1]
- C0422727
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
- UMLS CUI [1,3]
- C0011008
Description
If you tick "Adverse event", record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Select "Investigator discretion" if none of the other primary reasons are appropriate.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Description
Reason for withdrawal, Investigator discretion, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0022423
- UMLS CUI [1,3]
- C2349954
- UMLS CUI [1,4]
- C0566251
Description
Data owner should check the box when data cleaning is complete.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C1519316
Description
Office Use 1
Data type
text
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C1707478
- UMLS CUI [1,3]
- C0442603
- UMLS CUI [1,4]
- C1524063
Description
Office Use 2
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C1707478
- UMLS CUI [1,3]
- C0442603
- UMLS CUI [1,4]
- C1524063
Description
Pregnancy information (female)
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C0086287
Description
Pregnancy information (male)
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C0086582
Similar models
Treatment Blind, Study conclusion, Pregnancy information
- StudyEvent: ODM
C2347038 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C1519316 (UMLS CUI [1,2])
C1707478 (UMLS CUI [1,2])
C0442603 (UMLS CUI [1,3])
C1524063 (UMLS CUI [1,4])
C1707478 (UMLS CUI [1,2])
C0442603 (UMLS CUI [1,3])
C1524063 (UMLS CUI [1,4])
C1533716 (UMLS CUI-2)
C0086287 (UMLS CUI-3)
C1533716 (UMLS CUI-2)
C0086582 (UMLS CUI-3)
C3887537 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])