ID

44576

Descrição

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 Logs and Repeats form.

Link

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

Palavras-chave

Versões (3)
  1. 19/02/2020 19/02/2020 -
  2. 25/02/2020 25/02/2020 -
  3. 27/09/2021 27/09/2021 -
Titular dos direitos

GlaxoSmithKline

Transferido a

27 de setembro de 2021

DOI

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Licença

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

Inglês

Logs and Repeats

1 Formulários  
  1. StudyEvent: ODM
    1. Logs and Repeats
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Descrição

Date of visit/assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Descrição

day month year. Date below is the start of the study for this subject.

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
AE/Concomitant medication/Repeat an assessment check question
Descrição

AE/Concomitant medication/Repeat an assessment check question

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
UMLS CUI-3
C0205341
UMLS CUI-4
C0220825
Were any concomitant medications taken by the subject during the study?
Descrição

Concomitant medications during the study

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Did the subject experience any non-serious adverse events during the study?
Descrição

Non serious AE during the study

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Did the subject experience any serious adverse events during the study?
Descrição

SAE during the study

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Did the subject experience any CF exacerbations during the study?
Descrição

CF exacerbations during the study

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0010674
UMLS CUI [1,2]
C4086268
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0008976
Were any repeat haematology or clinical chemistry samples taken?
Descrição

Repeat haematology or clinical chemistry samples

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0525044
UMLS CUI [1,2]
C0205341
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C0205341
Were any repeat urinalysis samples taken?
Descrição

Repeat urinalysis samples

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0042014
Were any repeat ECGs performed?
Descrição

Repeat ECG

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Descrição

Abnormal, clinically significant ECG measurements recorded during the study

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0008976
Were any repeat vital signs recorded?
Descrição

Repeat vital signs

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat PD samples taken?
Descrição

Repeat PD samples

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0851347
UMLS CUI [1,3]
C0200345
Were any repeat Pulmonary Function Tests performed?
Descrição

Repeat PFT performance

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0024119
Were any repeat PK blood samples taken?
Descrição

Repeat PK blood sample

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0005767
UMLS CUI [1,4]
C0200345
Were any repeat sputum samples induced?
Descrição

Repeat sputum sample

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0038056
Liver event
Descrição

Liver event

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Descrição

If Yes to Liver Events, go to the LE DETAILS tab and complete the Liver Event forms

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C2746065
UMLS CUI [1,5]
C0243161
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Similar models

Logs and Repeats

1 Formulários
  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
AE/Concomitant medication/Repeat an assessment check question
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Concomitant medications
Code List
Were any concomitant medications taken by the subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Concomitant medications
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Concomitant medications
Code List
Did the subject experience any serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject experience any CF exacerbations during the study?
text
C0010674 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Concomitant medications
Code List
Did the subject experience any CF exacerbations during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat haematology or clinical chemistry samples taken?
text
C0525044 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
Concomitant medications
Code List
Were any repeat haematology or clinical chemistry samples taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat urinalysis samples taken?
text
C0200345 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
Concomitant medications
Code List
Were any repeat urinalysis samples taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat ECGs performed?
text
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Concomitant medications
Code List
Were any repeat ECGs performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
text
C0522055 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Concomitant medications
Code List
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat vital signs recorded?
text
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Concomitant medications
Code List
Were any repeat vital signs recorded?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat PD samples taken?
text
C0205341 (UMLS CUI [1,1])
C0851347 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Concomitant medications
Code List
Were any repeat PD samples taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat Pulmonary Function Tests performed?
text
C0205341 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Concomitant medications
Code List
Were any repeat Pulmonary Function Tests performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat PK blood samples taken?
text
C0205341 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,4])
Concomitant medications
Code List
Were any repeat PK blood samples taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat sputum samples induced?
text
C0205341 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0038056 (UMLS CUI [1,3])
Concomitant medications
Code List
Were any repeat sputum samples induced?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Liver event
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
text
C0023884 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,4])
C0243161 (UMLS CUI [1,5])
Concomitant medications
Code List
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
Yes (Y)
CL Item
No (N)
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