ID

39887

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 pulmonary function test. It has to be filled in for screening, V2b, V3, V5, follow-up and if required for logs/ repeats.

Link

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

Keywords

Versions (2)
  1. 2/24/20 2/24/20 -
  2. 2/28/20 2/28/20 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

February 28, 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

Pulmonary function test

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
Visit type
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Pulmonary function test
Description

Pulmonary function test

Alias
UMLS CUI-1
C0024119
Date of test
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2826247
Time of test
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C0429928
Bronchodilator
Description

For V2b fill in for both, pre- and post-bronchodilator. For V3, V5 and follow-up only fill in for pre-bronchodilator. This item has not to be filled in for screening and follow-up.

Data type

integer

Alias
UMLS CUI [1]
C0006280
Test type
Description

Pulmonary Function Test type

Data type

integer

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0332307
Reading number
Description

Please fill in three readings for both test types as well as for pre- and postbronchodilator.

Data type

integer

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0456984
Test result
Description

Pulmonary Function Test result

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0024119
L
Test not done
Description

Only to fill in for logs/ repeats.

Data type

boolean

Alias
UMLS CUI [1,1]
C1272696
UMLS CUI [1,2]
C0024119
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Similar models

Pulmonary function test

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
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
V2b (2)
CL Item
V3 (3)
CL Item
V5 (4)
CL Item
Follow-up (5)
CL Item
Logs/ Repeats (6)
Item Group
Pulmonary function test
C0024119 (UMLS CUI-1)
Date of test
Item
Date of test
date
C2826247 (UMLS CUI [1])
Time of test
Item
Time of test
time
C0429928 (UMLS CUI [1])
Item
Bronchodilator
integer
C0006280 (UMLS CUI [1])
Bronchodilator
Code List
Bronchodilator
CL Item
Pre-Bronchodilator (1)
CL Item
Post-Bronchodilator (2)
Item
Test type
integer
C0024119 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Test type
Code List
Test type
CL Item
FEV1 (1)
CL Item
FVC (2)
Item
Reading number
integer
C0024119 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
Reading number
Code List
Reading number
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Pulmonary Function Test result
Item
Test result
float
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Pulmonary Function Test not done
Item
Test not done
boolean
C1272696 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
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