ID

44681

Beschreibung

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 Sputum collection form. It has to be filled in for V2b, V5 and if requiered for logs/ repeats. This document can be filled in as often as necessary for logs/ repeats.

Link

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

Stichworte

Versionen (3)
  1. 19.02.20 19.02.20 -
  2. 04.03.20 04.03.20 -
  3. 27.09.21 27.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

27. September 2021

DOI

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Lizenz

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

Englisch

Sputum collection

1 Formulare  
  1. StudyEvent: ODM
    1. Sputum collection
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Visit type
Beschreibung

Please note for which visit you will fill in this document.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Dosing date and time
Beschreibung

Dosing date and time

Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C1264639
Dosing date
Beschreibung

day month year.

Datentyp

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Dosing time
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Sputum induction
Beschreibung

Sputum induction

Alias
UMLS CUI-1
C0038056
UMLS CUI-2
C0857127
Date of Bronchodilator Administration
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0006280
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0011008
Time of Bronchodilator Administration
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0006280
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0040223
Date of Sputum Processing
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0038056
UMLS CUI [1,2]
C1709694
UMLS CUI [1,3]
C0011008
Time of Sputum Processing
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0038056
UMLS CUI [1,2]
C1709694
UMLS CUI [1,3]
C0040223
Sputum sample quality
Beschreibung

Sputum sample quality

Alias
UMLS CUI-1
C0038056
UMLS CUI-2
C0332306
Sputum sample quality
Beschreibung

Sputum sample quality

Datentyp

integer

Alias
UMLS CUI [1,1]
C0038056
UMLS CUI [1,2]
C0332306
Sputum colour
Beschreibung

Sputum colour

Datentyp

integer

Alias
UMLS CUI [1,1]
C0038056
UMLS CUI [1,2]
C0009393
Sputum sample preparation and hemacytometry
Beschreibung

Sputum sample preparation and hemacytometry

Alias
UMLS CUI-1
C0038056
UMLS CUI-2
C1521827
UMLS CUI-3
C4054792
Resuspension volume
Beschreibung

Resuspension volume

Datentyp

float

Maßeinheiten
  • mL
Alias
UMLS CUI [1,1]
C2700258
UMLS CUI [1,2]
C1382107
mL
Weight of selected sputum
Beschreibung

Weight of selected sputum

Datentyp

float

Maßeinheiten
  • g
Alias
UMLS CUI [1,1]
C0807984
UMLS CUI [1,2]
C0038056
g
Total cell count
Beschreibung

Total cell count

Datentyp

float

Maßeinheiten
  • 10*4 Cells/mL
Alias
UMLS CUI [1]
C4272036
10*4 Cells/mL
Does the sample have >= 50% viability
Beschreibung

If no, do not send sample.

Datentyp

text

Alias
UMLS CUI [1,1]
C0038056
UMLS CUI [1,2]
C0443348
Sample collection summary
Beschreibung

Sample collection summary

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0242482
Were there any analysable/ acceptable slides sent for reading?
Beschreibung

Analysable/ acceptable slides

Datentyp

text

Alias
UMLS CUI [1,1]
C1879533
UMLS CUI [1,2]
C1705201
Sputum slide results entry
Beschreibung

Sputum slide results entry

Alias
UMLS CUI-1
C0038056
UMLS CUI-2
C1705201
UMLS CUI-3
C1254595
Date of Assessment
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Time of Assessment
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0040223
Reader Number
Beschreibung

Reader Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1707957
UMLS CUI [1,2]
C0237753
Sputum Result Slide Number
Beschreibung

Sputum Result Slide Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0038056
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C1705201
UMLS CUI [1,4]
C0237753
Cell type of result
Beschreibung

Fill in the result and the percent of total non squamous cells for each cell type (except for Squamous cells, Total non squamous cells, Total Cells counted) in the following items.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449475
UMLS CUI [1,2]
C1274040
Result, absolute count
Beschreibung

Result, absolute count

Datentyp

integer

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0750480
Result, percent of Total non squamous cells
Beschreibung

Result, percent of Total non squamous cells

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0439810
UMLS CUI [1,4]
C1545484
%
Was slide rejected?
Beschreibung

Rejected slide

Datentyp

text

Alias
UMLS CUI [1,1]
C1705201
UMLS CUI [1,2]
C1548437
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Ähnliche Modelle

Sputum collection

1 Formulare
  1. StudyEvent: ODM
    1. Sputum collection
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
V2b (1)
CL Item
V5 (2)
CL Item
Logs/ Repeats (3)
Item Group
Dosing date and time
C0178602 (UMLS CUI-1)
C1264639 (UMLS CUI-2)
Dosing date
Item
Dosing date
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Dosing time
Item
Dosing time
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Sputum induction
C0038056 (UMLS CUI-1)
C0857127 (UMLS CUI-2)
Date of Bronchodilator Administration
Item
Date of Bronchodilator Administration
date
C0006280 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Bronchodilator Administration
Item
Time of Bronchodilator Administration
time
C0006280 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Date of Sputum Processing
Item
Date of Sputum Processing
date
C0038056 (UMLS CUI [1,1])
C1709694 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Sputum Processing
Item
Time of Sputum Processing
time
C0038056 (UMLS CUI [1,1])
C1709694 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Sputum sample quality
C0038056 (UMLS CUI-1)
C0332306 (UMLS CUI-2)
Item
Sputum sample quality
integer
C0038056 (UMLS CUI [1,1])
C0332306 (UMLS CUI [1,2])
Sputum sample quality
Code List
Sputum sample quality
CL Item
Mucoid (1)
CL Item
Muco-Purulent (in between) (2)
CL Item
Purulent (3)
Item
Sputum colour
integer
C0038056 (UMLS CUI [1,1])
C0009393 (UMLS CUI [1,2])
Sputum colour
Code List
Sputum colour
CL Item
Colourless (1)
CL Item
Grey (2)
CL Item
Yellow (3)
CL Item
Red (bloody) (4)
CL Item
White (5)
CL Item
Green (6)
CL Item
Brown (7)
Item Group
Sputum sample preparation and hemacytometry
C0038056 (UMLS CUI-1)
C1521827 (UMLS CUI-2)
C4054792 (UMLS CUI-3)
Resuspension volume
Item
Resuspension volume
float
C2700258 (UMLS CUI [1,1])
C1382107 (UMLS CUI [1,2])
Weight of selected sputum
Item
Weight of selected sputum
float
C0807984 (UMLS CUI [1,1])
C0038056 (UMLS CUI [1,2])
Total cell count
Item
Total cell count
float
C4272036 (UMLS CUI [1])
Item
Does the sample have >= 50% viability
text
C0038056 (UMLS CUI [1,1])
C0443348 (UMLS CUI [1,2])
Viability of sample
Code List
Does the sample have >= 50% viability
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Sample collection summary
C0200345 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
Item
Were there any analysable/ acceptable slides sent for reading?
text
C1879533 (UMLS CUI [1,1])
C1705201 (UMLS CUI [1,2])
Viability of sample
Code List
Were there any analysable/ acceptable slides sent for reading?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Sputum slide results entry
C0038056 (UMLS CUI-1)
C1705201 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Time of Assessment
Item
Time of Assessment
time
C1516048 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reader Number
integer
C1707957 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Reader Number
Code List
Reader Number
CL Item
Reader 1 (1)
CL Item
Reader 2 (2)
CL Item
Reader 3 (3)
Item
Sputum Result Slide Number
integer
C0038056 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1705201 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Reader Number
Code List
Sputum Result Slide Number
CL Item
Slide 1 (1)
CL Item
Slide 2 (2)
CL Item
Slide 3 (3)
CL Item
Slide 4 (4)
Item
Cell type of result
integer
C0449475 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Cell type of result
Code List
Cell type of result
CL Item
Eosinophils  (1)
CL Item
Neutrophils  (2)
CL Item
Macrophages  (3)
CL Item
Lymphocytes  (4)
CL Item
Basophils  (5)
CL Item
Bronchial epithelial cells  (6)
CL Item
Squamous cells (7)
CL Item
Total non squamous cells  (8)
CL Item
Total Cells counted  (9)
Result, absolute count
Item
Result, absolute count
integer
C1274040 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Result, percent of Total non squamous cells
Item
Result, percent of Total non squamous cells
float
C1274040 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C1545484 (UMLS CUI [1,4])
Item
Was slide rejected?
text
C1705201 (UMLS CUI [1,1])
C1548437 (UMLS CUI [1,2])
Viability of sample
Code List
Was slide rejected?
CL Item
Yes (Y)
CL Item
No (N)
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