ID

39857

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 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

Stichworte

Versionen (1)
  1. 24.02.20 24.02.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

24. Februar 2020

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

12-Lead-ECG

1 Formulare  
  1. StudyEvent: ODM
    1. 12-Lead-ECG
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
12-Lead-ECG
Beschreibung

12-Lead-ECG

Alias
UMLS CUI-1
C0430456
Measurement number
Beschreibung

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.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0237753
Date of ECG
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beschreibung

PR Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
UMLS CUI [1,3]
C4072785
msec
Methods of QTC(b) Measurement
Beschreibung

If machine, please provide the QTCB in the appropriate item. If manual, please provide RR interval in the appropriate item.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
If machine method of QTC(b) measurement, provide QTCB
Beschreibung

QTCB

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C2911685
UMLS CUI [1,2]
C0336779
UMLS CUI [1,3]
C1882512
UMLS CUI [1,4]
C0855331
msec
If manual method of QTC(b) measurement, provide RR interval that precedes the measured QT interval.
Beschreibung

RR interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C2911685
UMLS CUI [1,2]
C0175674
UMLS CUI [1,3]
C0489636
UMLS CUI [1,4]
C0855331
msec
Result of the ECG
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
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Ähnliche Modelle

12-Lead-ECG

1 Formulare
  1. StudyEvent: ODM
    1. 12-Lead-ECG
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
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
12-Lead-ECG
C0430456 (UMLS CUI-1)
Item
Measurement number
integer
C0242485 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Measurement number
Code List
Measurement number
CL Item
1  (1)
CL Item
2 (2)
CL Item
3 (3)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,3])
Item
Methods of QTC(b) Measurement
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Methods of QTC(b) Measurement
Code List
Methods of QTC(b) Measurement
CL Item
Machine (1)
CL Item
Manual (2)
QTCB
Item
If machine method of QTC(b) measurement, provide QTCB
float
C2911685 (UMLS CUI [1,1])
C0336779 (UMLS CUI [1,2])
C1882512 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
RR interval
Item
If manual method of QTC(b) measurement, provide RR interval that precedes the measured QT interval.
float
C2911685 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0489636 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
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