ID

24912

Description

Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease

Keywords

Versions (2)
  1. 8/22/17 8/22/17 -
  2. 9/4/17 9/4/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 22, 2017

DOI

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License

Creative Commons BY-NC 3.0
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12-lead electrocardiogram report determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

English

12-lead electrocardiogram report determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Description

patient's initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Description

patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
PRE-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT
Description

PRE-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0439565
ACTUAL TIME OF ECG READING
Description

24-hour-clock

Data type

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0040223
HEART RATE
Description

heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
P-R INTERVAL
Description

P-R interval

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS DURATION
Description

QRS duration

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0429025
sec
QTc
Description

QTc interval

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0489625
sec
OVERALL ECG RESULTS
Description

ECG results

Data type

integer

Alias
UMLS CUI [1]
C1623258
OVERALL ECG RESULTS
Description

If "Abnormal - clinically significant" above, describe

Data type

text

Alias
UMLS CUI [1]
C1623258
4-HOUR POST-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT
Description

4-HOUR POST-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0439568
ACTUAL TIME OF ECG READING
Description

24-hour-clock

Data type

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0040223
HEART RATE
Description

heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
P-R INTERVAL
Description

P-R interval

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS DURATION
Description

QRS duration

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0429025
sec
QTc
Description

QTc interval

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0489625
sec
OVERALL ECG RESULTS
Description

ECG results

Data type

integer

Alias
UMLS CUI [1]
C1623258
OVERALL ECG RESULTS
Description

If "Abnormal - clinically significant" above, describe

Data type

text

Alias
UMLS CUI [1]
C1623258
12-HOUR POST-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT
Description

12-HOUR POST-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0439568
ACTUAL TIME OF ECG READING
Description

24-hour-clock

Data type

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0040223
HEART RATE
Description

heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
P-R INTERVAL
Description

P-R interval

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS DURATION
Description

QRS duration

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0429025
sec
QTc
Description

QTc interval

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0489625
sec
OVERALL ECG RESULTS
Description

ECG results

Data type

integer

Alias
UMLS CUI [1]
C1623258
OVERALL ECG RESULTS
Description

If "Abnormal - clinically significant" above, describe

Data type

text

Alias
UMLS CUI [1]
C1623258
24-HOUR POST-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT
Description

24-HOUR POST-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0439568
ACTUAL TIME OF ECG READING
Description

24-hour-clock

Data type

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0040223
HEART RATE
Description

heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
P-R INTERVAL
Description

P-R interval

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS DURATION
Description

QRS duration

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0429025
sec
QTc
Description

QTc interval

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0489625
sec
OVERALL ECG RESULTS
Description

ECG results

Data type

integer

Alias
UMLS CUI [1]
C1623258
OVERALL ECG RESULTS
Description

If "Abnormal - clinically significant" above, describe

Data type

text

Alias
UMLS CUI [1]
C1623258
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Similar models

12-lead electrocardiogram report determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
Item Group
PRE-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT
C1623258 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
time of ECG reading
Item
ACTUAL TIME OF ECG READING
time
C1623258 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate
Item
HEART RATE
integer
C0018810 (UMLS CUI [1])
P-R interval
Item
P-R INTERVAL
float
C0429087 (UMLS CUI [1])
QRS duration
Item
QRS DURATION
float
C0429025 (UMLS CUI [1])
QTc interval
Item
QTc
float
C0489625 (UMLS CUI [1])
Item
OVERALL ECG RESULTS
integer
C1623258 (UMLS CUI [1])
ECG results
Code List
OVERALL ECG RESULTS
CL Item
normal  (1)
CL Item
abnormal, not clinically significant  (2)
CL Item
abnormal, clinically significant (3)
ECG results
Item
OVERALL ECG RESULTS
text
C1623258 (UMLS CUI [1])
Item Group
4-HOUR POST-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT
C1623258 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of ECG reading
Item
ACTUAL TIME OF ECG READING
time
C1623258 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate
Item
HEART RATE
integer
C0018810 (UMLS CUI [1])
P-R interval
Item
P-R INTERVAL
float
C0429087 (UMLS CUI [1])
QRS duration
Item
QRS DURATION
float
C0429025 (UMLS CUI [1])
QTc interval
Item
QTc
float
C0489625 (UMLS CUI [1])
Item
OVERALL ECG RESULTS
integer
C1623258 (UMLS CUI [1])
ECG results
Code List
OVERALL ECG RESULTS
CL Item
normal  (1)
CL Item
abnormal, not clinically significant  (2)
CL Item
abnormal, clinically significant (3)
ECG results
Item
OVERALL ECG RESULTS
text
C1623258 (UMLS CUI [1])
Item Group
12-HOUR POST-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT
C1623258 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of ECG reading
Item
ACTUAL TIME OF ECG READING
time
C1623258 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate
Item
HEART RATE
integer
C0018810 (UMLS CUI [1])
P-R interval
Item
P-R INTERVAL
float
C0429087 (UMLS CUI [1])
QRS duration
Item
QRS DURATION
float
C0429025 (UMLS CUI [1])
QTc interval
Item
QTc
float
C0489625 (UMLS CUI [1])
Item
OVERALL ECG RESULTS
integer
C1623258 (UMLS CUI [1])
ECG results
Code List
OVERALL ECG RESULTS
CL Item
normal  (1)
CL Item
abnormal, not clinically significant  (2)
CL Item
abnormal, clinically significant (3)
ECG results
Item
OVERALL ECG RESULTS
text
C1623258 (UMLS CUI [1])
Item Group
24-HOUR POST-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT
C1623258 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of ECG reading
Item
ACTUAL TIME OF ECG READING
time
C1623258 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate
Item
HEART RATE
integer
C0018810 (UMLS CUI [1])
P-R interval
Item
P-R INTERVAL
float
C0429087 (UMLS CUI [1])
QRS duration
Item
QRS DURATION
float
C0429025 (UMLS CUI [1])
QTc interval
Item
QTc
float
C0489625 (UMLS CUI [1])
Item
OVERALL ECG RESULTS
integer
C1623258 (UMLS CUI [1])
ECG results
Code List
OVERALL ECG RESULTS
CL Item
normal  (1)
CL Item
abnormal, not clinically significant  (2)
CL Item
abnormal, clinically significant (3)
ECG results
Item
OVERALL ECG RESULTS
text
C1623258 (UMLS CUI [1])
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