ID

33230

Description

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the 12-LEAD-ECG form. It has to be filled in for screening, study visit and follow up.

Link

https://clinicaltrials.gov/ct2/show/NCT00599612

Keywords

Versions (3)
  1. 11/28/18 11/28/18 -
  2. 12/1/18 12/1/18 -
  3. 12/3/18 12/3/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

December 3, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

English

12-Lead Electrocardiogram

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Description

Visit Description

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
12-lead ECG
Description

12-lead ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1623258
ECG-number
Description

For screening: ECG1-3 are mandatory for screening. ECG4-6 are possible as unscheduled. For study visit: ECG1-8 are paired at certain points in time, from ECG1 for pre-dose ECG to ECG8 at 24 h post-dose (See Item "planned relative Time", Codelist 3-10). ECG1-6 are possible as unscheduled. For Follow-up: ECG 1 is mandatory. ECG2 and 3 are possible as unscheduled.

Data type

integer

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0180600
Start Date of ECG
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time ECG
Description

3-10: It is only for study visit. 1, 2 and 11 as indicated.

Data type

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
Start Time of ECG
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • Beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0430456
Beats/min
PR Interval
Description

PR Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS Duration
Description

QRS Duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
QTc Interval
Description

QTc Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0430456
msec
Result of the ECG
Description

Complete the additional ECG Abnormalities page if clinically significant abnormalities are present. Additional for study visit and follow up: Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.

Data type

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
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Similar models

12-Lead Electrocardiogram

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item
Visit Description
integer
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Visit Description
Code List
Visit Description
CL Item
Screening (1)
CL Item
Study visit (2)
CL Item
Follow up (3)
Item Group
12-lead ECG
C0430456 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
Item
ECG-number
integer
C1300638 (UMLS CUI [1,1])
C0180600 (UMLS CUI [1,2])
ECG-number
Code List
ECG-number
CL Item
ECG1 (1)
CL Item
ECG2 (2)
CL Item
ECG3 (3)
CL Item
ECG4 (4)
CL Item
ECG5 (5)
CL Item
ECG6 (6)
CL Item
ECG7 (7)
CL Item
ECG8 (8)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time ECG
integer
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time ECG
Code List
Planned Relative Time ECG
CL Item
Screening (1)
CL Item
Unscheduled (2)
CL Item
Pre-dose (3)
CL Item
30 mins (4)
CL Item
1 hr (5)
CL Item
2 hrs (6)
CL Item
4 hrs (7)
CL Item
6 hrs (8)
CL Item
8 hrs (9)
CL Item
24 hrs (10)
CL Item
Follow up (11)
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (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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