ID

39859

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)
  1. 2/19/20 2/19/20 -
  2. 2/24/20 2/24/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 24, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

English

Treatment Blind, Study conclusion, Pregnancy information

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Status of treatment Blind
Description

Status of treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
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
Date blind broken
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Time blind broken
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0040223
Reason blind broken
Description

Reason blind broken

Data type

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If other reason blind broken, please specify
Description

Other Reason blind broken

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
Study conclusion
Description

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of last contact
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Description

If you tick yes, please complete details in the following items.

Data type

text

Alias
UMLS CUI [1]
C0422727
Date of decision to withdraw
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Primary reason for withdrawal
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
If Investigator discretion for subject's withdrawal, please specify
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
Case book ready for signature
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
Office Use 1
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
Office Use 2
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
Pregnancy information (female)
Description

Pregnancy information (female)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
UMLS CUI-3
C0086287
Did the subject become pregnant during the study?
Description

If yes, complete the paper Pregnancy Notification form.

Data type

text

Alias
UMLS CUI [1]
C3828490
Pregnancy information (male)
Description

Pregnancy information (male)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
UMLS CUI-3
C0086582
Did a female partner of the male subject become pregnant during the study?
Description

If yes, complete the paper Pregnancy Notification form.

Data type

text

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C3887537
UMLS CUI [1,3]
C3828490
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Similar models

Treatment Blind, Study conclusion, Pregnancy information

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Status of treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Treatment blind broken
Code List
Was the treatment blind broken during the study?
CL Item
Yes (Y)
CL Item
No (N)
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time blind broken
Item
Time blind broken
time
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (2)
Other Reason blind broken
Item
If other reason blind broken, please specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Subject withdrawn
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes (Y)
Date of decision to withdraw
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Protocol deviation (2)
CL Item
Subject reached protocol defined stopping criteria (3)
CL Item
Study closed/terminated (4)
CL Item
Lost to Follow-up (5)
CL Item
Investigator discretion (6)
CL Item
Withdrew consent (7)
Reason for withdrawal, Investigator discretion, specification
Item
If Investigator discretion for subject's withdrawal, please specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Case book ready for signature
Item
Case book ready for signature
boolean
C1706256 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Item
Office Use 1
text
C0008976 (UMLS CUI [1,1])
C1707478 (UMLS CUI [1,2])
C0442603 (UMLS CUI [1,3])
C1524063 (UMLS CUI [1,4])
Treatment blind broken
Code List
Office Use 1
CL Item
Yes (Y)
CL Item
No (N)
Item
Office Use 2
integer
C0008976 (UMLS CUI [1,1])
C1707478 (UMLS CUI [1,2])
C0442603 (UMLS CUI [1,3])
C1524063 (UMLS CUI [1,4])
Treatment blind broken
Code List
Office Use 2
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
Item Group
Pregnancy information (female)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C0086287 (UMLS CUI-3)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Treatment blind broken
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Pregnancy information (male)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C0086582 (UMLS CUI-3)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0086287 (UMLS CUI [1,1])
C3887537 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])
Treatment blind broken
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
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