ID

32685

Description

Study ID: 107038 Clinical Study ID: LPL107038 Study Title: Study to Estimate the Dose Proportionality of the Enteric-Coated Freebase Formulation of SB-480848 Patient Level Data:  Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: Tyrisa ,US Study Indication: Atherosclerosis

Keywords

  1. 11/12/18 11/12/18 -
  2. 11/12/18 11/12/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 12, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Estimation of Dose Proportionality of Darapladib - 107038

Visit 1: 12-lead ECG Form

Dosing Schedule
Description

Dosing Schedule

Dosing Date
Description

Dosing Date

Data type

date

Dosing Time
Description

Dosing Time

Data type

time

Timepoint 1
Description

Timepoint 1

Date of ECG
Description

Date of ECG

Data type

date

Time of ECG
Description

Time of ECG

Data type

time

Heart rate
Description

Heart rate

Data type

integer

PR Interval
Description

PR Interval

Data type

float

Measurement units
  • msec
msec
QRS Duration
Description

QRS Duration

Data type

float

Measurement units
  • msec
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

float

Measurement units
  • msec
msec
QTc Interval
Description

QTc Interval

Data type

float

Method of QTc Calculation
Description

Method of QTc Calculation

Data type

text

Result of the ECG
Description

Result of the ECG

Data type

text

Similar models

Visit 1: 12-lead ECG Form

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Dosing Schedule
Dosing Date
Item
Dosing Date
date
Dosing Time
Item
Dosing Time
time
Item Group
Timepoint 1
Date of ECG
Item
Date of ECG
date
Time of ECG
Item
Time of ECG
time
Heart rate
Item
Heart rate
integer
PR Interval
Item
PR Interval
float
QRS Duration
Item
QRS Duration
float
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
QTc Interval
Item
QTc Interval
float
Item
Method of QTc Calculation
text
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
text
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal, clinically significant (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE) (3)
CL Item
No result (not available) (4)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial