ID

24912

Beschrijving

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

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Versies (2)
  1. 22-08-17 22-08-17 -
  2. 04-09-17 04-09-17 -
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GlaxoSmithKline

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22 augustus 2017

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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

Engels

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

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Beschrijving

patient's initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Beschrijving

patient number

Datatype

integer

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

PRE-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT

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

24-hour-clock

Datatype

time

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

heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
P-R INTERVAL
Beschrijving

P-R interval

Datatype

float

Maateenheden
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS DURATION
Beschrijving

QRS duration

Datatype

float

Maateenheden
  • sec
Alias
UMLS CUI [1]
C0429025
sec
QTc
Beschrijving

QTc interval

Datatype

float

Maateenheden
  • sec
Alias
UMLS CUI [1]
C0489625
sec
OVERALL ECG RESULTS
Beschrijving

ECG results

Datatype

integer

Alias
UMLS CUI [1]
C1623258
OVERALL ECG RESULTS
Beschrijving

If "Abnormal - clinically significant" above, describe

Datatype

text

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

4-HOUR POST-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT

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

24-hour-clock

Datatype

time

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

heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
P-R INTERVAL
Beschrijving

P-R interval

Datatype

float

Maateenheden
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS DURATION
Beschrijving

QRS duration

Datatype

float

Maateenheden
  • sec
Alias
UMLS CUI [1]
C0429025
sec
QTc
Beschrijving

QTc interval

Datatype

float

Maateenheden
  • sec
Alias
UMLS CUI [1]
C0489625
sec
OVERALL ECG RESULTS
Beschrijving

ECG results

Datatype

integer

Alias
UMLS CUI [1]
C1623258
OVERALL ECG RESULTS
Beschrijving

If "Abnormal - clinically significant" above, describe

Datatype

text

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

12-HOUR POST-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT

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

24-hour-clock

Datatype

time

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

heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
P-R INTERVAL
Beschrijving

P-R interval

Datatype

float

Maateenheden
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS DURATION
Beschrijving

QRS duration

Datatype

float

Maateenheden
  • sec
Alias
UMLS CUI [1]
C0429025
sec
QTc
Beschrijving

QTc interval

Datatype

float

Maateenheden
  • sec
Alias
UMLS CUI [1]
C0489625
sec
OVERALL ECG RESULTS
Beschrijving

ECG results

Datatype

integer

Alias
UMLS CUI [1]
C1623258
OVERALL ECG RESULTS
Beschrijving

If "Abnormal - clinically significant" above, describe

Datatype

text

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

24-HOUR POST-DOSE 12-LEAD ELECTROCARDIOGRAM REPORT

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

24-hour-clock

Datatype

time

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

heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
P-R INTERVAL
Beschrijving

P-R interval

Datatype

float

Maateenheden
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS DURATION
Beschrijving

QRS duration

Datatype

float

Maateenheden
  • sec
Alias
UMLS CUI [1]
C0429025
sec
QTc
Beschrijving

QTc interval

Datatype

float

Maateenheden
  • sec
Alias
UMLS CUI [1]
C0489625
sec
OVERALL ECG RESULTS
Beschrijving

ECG results

Datatype

integer

Alias
UMLS CUI [1]
C1623258
OVERALL ECG RESULTS
Beschrijving

If "Abnormal - clinically significant" above, describe

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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