ID

24568

Description

Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: 12-lead ECG.

Keywords

  1. 8/6/17 8/6/17 -
  2. 9/7/17 9/7/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 6, 2017

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.

12-lead ECG GSK study Dyskinesia in Parkinson's disease NCT00363727

12-lead ECG GSK study Dyskinesia in Parkinson's disease NCT00363727

General information
Description

General information

Protocol identifier
Description

Protocol identifier

Data type

text

Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit description
Description

Visit description

Data type

text

12-lead ECG
Description

12-lead ECG

Date of ECG
Description

Date of ECG

Data type

date

Time of ECG
Description

Time of ECG

Data type

time

Ventricular Rate
Description

Ventricular Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
beats/min
PR Interval
Description

PR Interval

Data type

integer

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

QRS Duration

Data type

integer

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

Uncorrected QT Interval

Data type

integer

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

QTc Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0855331
msec
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Result of the ECG
Description

ECG results

Data type

integer

Similar models

12-lead ECG GSK study Dyskinesia in Parkinson's disease NCT00363727

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General information
Protocol identifier
Item
Protocol identifier
text
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit description
Item
Visit description
text
Item Group
12-lead ECG
Date of ECG
Item
Date of ECG
date
Time of ECG
Item
Time of ECG
time
Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
integer
C0855331 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)

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