ID
44576
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 Logs and Repeats form.
Link
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Keywords
Versions (3)
- 2/19/20 2/19/20 -
- 2/25/20 2/25/20 -
- 9/27/21 9/27/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 27, 2021
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
Logs and Repeats
- StudyEvent: ODM
Description
Date of visit/assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Description
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
Description
Concomitant medications during the study
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Description
Non serious AE during the study
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Description
SAE during the study
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Description
CF exacerbations during the study
Data type
text
Alias
- UMLS CUI [1,1]
- C0010674
- UMLS CUI [1,2]
- C4086268
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008976
Description
Repeat haematology or clinical chemistry samples
Data type
text
Alias
- UMLS CUI [1,1]
- C0525044
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [2,1]
- C0018941
- UMLS CUI [2,2]
- C0205341
Description
Repeat urinalysis samples
Data type
text
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0042014
Description
Repeat ECG
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Description
Abnormal, clinically significant ECG measurements recorded during the study
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C2985739
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008976
Description
Repeat vital signs
Data type
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Description
Repeat PD samples
Data type
text
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0851347
- UMLS CUI [1,3]
- C0200345
Description
Repeat PFT performance
Data type
text
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0024119
Description
Repeat PK blood sample
Data type
text
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005767
- UMLS CUI [1,4]
- C0200345
Description
Repeat sputum sample
Data type
text
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0038056
Description
Liver event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Description
If Yes to Liver Events, go to the LE DETAILS tab and complete the Liver Event forms
Data type
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
Similar models
Logs and Repeats
- StudyEvent: ODM
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0205341 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
C0205341 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0205341 (UMLS CUI [1,2])
C0851347 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0024119 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0038056 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,4])
C0243161 (UMLS CUI [1,5])