ID

39869

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 Cystic fibrosis exacerbations form. It has to be filled in if the subject has a cystic fibrosis exacerbation during the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Keywords

Versions (2)
  1. 2/25/20 2/25/20 -
  2. 3/2/20 3/2/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 25, 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.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

English

Cystic fibrosis exacerbations

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
Cystic fibrosis exacerbations
Description

Cystic fibrosis exacerbations

Alias
UMLS CUI-1
C0010674
UMLS CUI-2
C4086268
Date of Exacerbation Onset
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0010674
UMLS CUI [1,3]
C4086268
Time of Exacerbation Onset
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C0010674
UMLS CUI [1,3]
C4086268
Date of Exacerbation Resolution
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2699488
UMLS CUI [1,3]
C0010674
UMLS CUI [1,4]
C4086268
Time of Exacerbation Resolution
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2699488
UMLS CUI [1,3]
C0010674
UMLS CUI [1,4]
C4086268
Were antibiotics prescribed for the exacerbation?
Description

Antibiotics prescription for exacerbation

Data type

text

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0033080
UMLS CUI [1,3]
C0010674
UMLS CUI [1,4]
C4086268
Was the subject hospitalised due to exacerbation?
Description

Hospitalisation of subject due to exacerbation

Data type

text

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0010674
UMLS CUI [1,3]
C4086268
Was the subject withdrawn due to exacerbation?
Description

Withdrawal of subject due to exacerbation

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0010674
UMLS CUI [1,3]
C4086268
Back to the top of the page

Similar models

Cystic fibrosis exacerbations

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])
Item Group
Cystic fibrosis exacerbations
C0010674 (UMLS CUI-1)
C4086268 (UMLS CUI-2)
Date of Exacerbation Onset
Item
Date of Exacerbation Onset
date
C0574845 (UMLS CUI [1,1])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
Time of Exacerbation Onset
Item
Time of Exacerbation Onset
time
C0449244 (UMLS CUI [1,1])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
Date of Exacerbation Resolution
Item
Date of Exacerbation Resolution
date
C0011008 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
Time of Exacerbation Resolution
Item
Time of Exacerbation Resolution
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
Item
Were antibiotics prescribed for the exacerbation?
text
C0003232 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
Antibiotics prescription for exacerbation
Code List
Were antibiotics prescribed for the exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was the subject hospitalised due to exacerbation?
text
C0019993 (UMLS CUI [1,1])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
Antibiotics prescription for exacerbation
Code List
Was the subject hospitalised due to exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was the subject withdrawn due to exacerbation?
text
C0422727 (UMLS CUI [1,1])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
Antibiotics prescription for exacerbation
Code List
Was the subject withdrawn due to exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
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