ID

39759

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 electronically transferred lab data form. It has to be filled in for screening,V2a, V3, V5, follow-up and if requiered for logs/ repeats.

Link

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

Keywords

Versions (2)
  1. 2/17/20 2/17/20 -
  2. 3/4/20 3/4/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 17, 2020

DOI

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License

Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

English

Laboratory data

1 forms  
  1. StudyEvent: ODM
    1. Laboratory data
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
Visit type
Description

Please not for which visit you will fill in this document

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Haematology
Description

Haematology

Alias
UMLS CUI-1
C0018941
Date of blood sampling
Description

day month year. If a blood sample has not taken/ not done, please tick the item "no blood sample taken".

Data type

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Time of blood sampling
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
No blood sample taken
Description

No blood sample taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1272696
Clinical chemistry
Description

Clinical chemistry

Alias
UMLS CUI-1
C0008000
Tick, if same as haematology sample.
Description

Same as haematology sample

Data type

boolean

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0445247
UMLS CUI [1,4]
C0018941
Date of blood sampling
Description

day month year. If a blood sample has not taken/ not done, please tick the item "no blood sample taken".

Data type

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Time of blood sampling
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
No blood sample taken
Description

No blood sample taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1272696
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
Date of urine sampling
Description

day month year. If a sample has not taken/ not done, please tick the item "no sample taken".

Data type

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Time of urine sampling
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
No sample taken
Description

No sample taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1272696
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Similar models

Laboratory data

1 forms
  1. StudyEvent: ODM
    1. Laboratory data
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
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screening (1)
CL Item
V2a (2)
CL Item
V3 (3)
CL Item
V5 (4)
CL Item
Follow-up (5)
CL Item
Logs/ repeats (6)
Item Group
Haematology
C0018941 (UMLS CUI-1)
Date of blood sampling
Item
Date of blood sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of blood sampling
Item
Time of blood sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
No blood sample taken
Item
No blood sample taken
boolean
C0005834 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
Clinical chemistry
C0008000 (UMLS CUI-1)
Same as haematology sample
Item
Tick, if same as haematology sample.
boolean
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,4])
Date of blood sampling
Item
Date of blood sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of blood sampling
Item
Time of blood sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
No blood sample taken
Item
No blood sample taken
boolean
C0005834 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Date of urine sampling
Item
Date of urine sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of urine sampling
Item
Time of urine sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
No sample taken
Item
No sample taken
boolean
C0005834 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
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