ID
39857
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 12-Lead-ECG form. 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 (1)
- 2/24/20 2/24/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 24, 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
12-Lead-ECG
- StudyEvent: ODM
Description
12-Lead-ECG
Alias
- UMLS CUI-1
- C0430456
Description
Only to fill in for screening. For the visits 2b the measurement has to be pre-dose. Also for V3 and V5 there has to be a pre-dose single measurement.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0242485
- UMLS CUI [1,2]
- C0237753
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2826640
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
PR Interval
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Description
Uncorrected QT Interval
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
- UMLS CUI [1,3]
- C4072785
Description
If machine, please provide the QTCB in the appropriate item. If manual, please provide RR interval in the appropriate item.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
QTCB
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C2911685
- UMLS CUI [1,2]
- C0336779
- UMLS CUI [1,3]
- C1882512
- UMLS CUI [1,4]
- C0855331
Description
RR interval
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C2911685
- UMLS CUI [1,2]
- C0175674
- UMLS CUI [1,3]
- C0489636
- UMLS CUI [1,4]
- C0855331
Description
If you tick "Abnormal - Clinically significant", please complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Similar models
12-Lead-ECG
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0336779 (UMLS CUI [1,2])
C1882512 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
C0175674 (UMLS CUI [1,2])
C0489636 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
C1274040 (UMLS CUI [1,2])