ID

43527

Description

Documentation Part: Screening An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Link

https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1

Keywords

Versions (2)
  1. 4/25/17 4/25/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Screening Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

English

Screening Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 forms  
Subject Information
Description

Subject Information

Alias
UMLS CUI-1
C2707520
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0220908
Day Month Year
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1]
C0421451
Day Month Year
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

text

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Description

Geographic Ancestry

Data type

text

Alias
UMLS CUI [1]
C0034510
Child-bearing Potential (Complete for Female Subjects Only)
Description

Child-bearing Potential (Complete for Female Subjects Only)

Alias
UMLS CUI-1
C1960468
Child-bearing Potential: Check one
Description

Child-bearing Potential: Check one

Data type

text

Alias
UMLS CUI [1,1]
C1960468
UMLS CUI [1,2]
C0015895
Pregnancy Test (Complete for Female Subjects of Child-bearing Potential Only)
Description

Pregnancy Test (Complete for Female Subjects of Child-bearing Potential Only)

Alias
UMLS CUI-1
C0032976
Date sample taken
Description

Date sample taken

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0032976
Day Month Year
Results
Description

Results

Data type

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0032976
Local Laboratory Result Data
Description

Local Laboratory Result Data

Alias
UMLS CUI-1
C1254595
FSH/LH Result
Description

FSH/LH Result

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2122182
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0009488
Diagnosis
Description

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Data type

text

Alias
UMLS CUI [1]
C0011900
Current
Description

Current

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0012634
Past
Description

Past

Data type

boolean

Alias
UMLS CUI [1,1]
C1444637
UMLS CUI [1,2]
C0012634
Urine Drug Screen
Description

Urine Drug Screen

Alias
UMLS CUI-1
C0202274
Date and time of sample taken
Description

Date and time of sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Amphetamines
Description

Amphetamines

Data type

text

Alias
UMLS CUI [1]
C0002667
Barbiturates
Description

Barbiturates

Data type

text

Alias
UMLS CUI [1]
C0004745
Cannabis
Description

Cannabis

Data type

text

Alias
UMLS CUI [1]
C0936079
Cocaine
Description

Cocaine

Data type

text

Alias
UMLS CUI [1]
C0009170
Morphine and derivatives
Description

Morphine and derivatives

Data type

text

Alias
UMLS CUI [1]
C0279996
Alcohol Test
Description

Alcohol Test

Alias
UMLS CUI-1
C0868676
Date sample taken
Description

Date sample taken

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0868676
Day Month Year
Results, check one
Description

Results, check one

Data type

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0868676
Serology - HIV/Hepatitis Screen
Description

Serology - HIV/Hepatitis Screen

Alias
UMLS CUI-1
C0459958
UMLS CUI-2
C1445958
Date sample taken
Description

Date sample taken

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0459958
UMLS CUI [1,2]
C1445958
UMLS CUI [1,3]
C1302413
Day Month Year
HIV antibody
Description

HIV antibody

Data type

text

Alias
UMLS CUI [1]
C0019683
Hepatitis B surface antigen
Description

Hepatitis B surface antigen

Data type

text

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Description

Hepatitis C antibody

Data type

text

Alias
UMLS CUI [1]
C0281863
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Description

Date of Assessment

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C0031809
Day Month Year
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Hair and skin
Description

Hair and skin

Data type

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Lymph nodes
Description

Lymph nodes

Data type

text

Alias
UMLS CUI [1]
C0024204
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Eyes
Description

Eyes

Data type

text

Alias
UMLS CUI [1]
C0200149
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Ears, Nose and Throat
Description

Ears, Nose and Throat

Data type

text

Alias
UMLS CUI [1]
C0278350
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Breasts
Description

Breasts

Data type

text

Alias
UMLS CUI [1]
C0199850
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Respiratory
Description

Respiratory

Data type

text

Alias
UMLS CUI [1]
C0436121
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Cardiovascular
Description

Cardiovascular

Data type

text

Alias
UMLS CUI [1]
C3854344
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Abdomen
Description

Abdomen

Data type

text

Alias
UMLS CUI [1]
C0562238
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Urogenital
Description

Urogenital

Data type

text

Alias
UMLS CUI [1]
C1828035
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Pelvic
Description

Pelvic

Data type

text

Alias
UMLS CUI [1]
C0200045
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Rectal
Description

Rectal

Data type

text

Alias
UMLS CUI [1]
C0199900
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Musculoskeletal
Description

Musculoskeletal

Data type

text

Alias
UMLS CUI [1]
C0475091
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Neurological
Description

Neurological

Data type

text

Alias
UMLS CUI [1]
C0027853
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Mental Status
Description

Mental Status

Data type

text

Alias
UMLS CUI [1]
C0278060
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
History of tobacco use
Description

History of tobacco use

Alias
UMLS CUI-1
C0841002
What is the subject's history of tobacco use?
Description

What is the subject's history of tobacco use?

Data type

text

Alias
UMLS CUI [1]
C0841002
If former smoker: When did the subject last smoke/use tobacco?
Description

If former smoker: When did the subject last smoke/use tobacco?

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1]
C0543414
Day Month Year
If current or former smoker, answer the following question: Number of cigarettes smoked per day?
Description

If current or former smoker, answer the following question: Number of cigarettes smoked per day?

Data type

integer

Measurement units
  • cigarettes per day
Alias
UMLS CUI [1]
C3694146
cigarettes per day
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Description

Body Mass Index

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Date
Description

Date

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Day Month Year
Planned Relative Time
Description

Planned Relative Time

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual time
Description

Actual time

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1]
C0040223
Hr : Min
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Description

Subject position

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1262869
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start date of ECG
Description

Start date of ECG

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
Day Month Year
Planned Relative Time
Description

Planned Relative Time

Data type

text

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

Start Time of ECG

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0013798
Hr : Min
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]
C0489625
msec
Result of the ECG
Description

Result of the ECG

Data type

text

Alias
UMLS CUI [1]
C0438154
12-Lead ECG Abnormalities
Description

12-Lead ECG Abnormalities

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
Date of ECG
Description

Date of ECG

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1]
C2826640
Day Month Year
Time of ECG
Description

Time of ECG

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Hr : Min
12-Lead ECG Abnormalities: A. Rhythm
Description

12-Lead ECG Abnormalities: A. Rhythm

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
UMLS CUI-3
C0199556
Sinus bradycardia
Description

Sinus bradycardia

Data type

boolean

Alias
UMLS CUI [1]
C0085610
Sinus bradycardia (heart rate 40-50 beats/min)
Description

Sinus bradycardia (heart rate 40-50 beats/min)

Data type

boolean

Alias
UMLS CUI [1]
C0085610
Sinus bradycardia (heart rate 30-39 beats/min)
Description

Sinus bradycardia (heart rate 30-39 beats/min)

Data type

boolean

Alias
UMLS CUI [1]
C0085610
Sinus bradycardia (heart rate < 30 beats/min)
Description

Sinus bradycardia (heart rate < 30 beats/min)

Data type

boolean

Alias
UMLS CUI [1]
C0085610
Sinus pause
Description

Sinus pause

Data type

boolean

Alias
UMLS CUI [1]
C1955864
Sinus tachycardia (heart rate >100 beats/min)
Description

Sinus tachycardia (heart rate >100 beats/min)

Data type

boolean

Alias
UMLS CUI [1]
C0039239
Ectopic supraventricular beats
Description

Ectopic supraventricular beats

Data type

boolean

Alias
UMLS CUI [1]
C0033036
Ectopic supraventricular rhythm
Description

Ectopic supraventricular rhythm

Data type

boolean

Alias
UMLS CUI [1]
C2348376
Wandering atrial pacemaker
Description

Wandering atrial pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C1321523
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
Description

Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)

Data type

boolean

Alias
UMLS CUI [1]
C0221158
Supraventricular tachycardia (heart rate >100 beats/min)
Description

Supraventricular tachycardia (heart rate >100 beats/min)

Data type

boolean

Alias
UMLS CUI [1]
C0039240
Atrial flutter
Description

Atrial flutter

Data type

boolean

Alias
UMLS CUI [1]
C0004239
Atrial fibrillation
Description

Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
Junctional rhythm (heart rate ≤100 beats/min)
Description

Junctional rhythm (heart rate ≤100 beats/min)

Data type

boolean

Alias
UMLS CUI [1]
C0232208
Junctional rhythm
Description

Junctional rhythm

Data type

boolean

Alias
UMLS CUI [1]
C0232208
Junctional tachycardia (heart rate > 100 beats/min)
Description

Junctional tachycardia (heart rate > 100 beats/min)

Data type

boolean

Alias
UMLS CUI [1]
C0039235
Ectopic ventricular beats
Description

Ectopic ventricular beats

Data type

boolean

Alias
UMLS CUI [1]
C0151636
Ventricular couplets
Description

Ventricular couplets

Data type

boolean

Alias
UMLS CUI [1]
C0429001
Bigeminy
Description

Bigeminy

Data type

boolean

Alias
UMLS CUI [1]
C0262662
Trigeminy
Description

Trigeminy

Data type

boolean

Alias
UMLS CUI [1]
C0428999
Electrical alternans
Description

Electrical alternans

Data type

boolean

Alias
UMLS CUI [1]
C1142551
R on T phenomenon
Description

R on T phenomenon

Data type

boolean

Alias
UMLS CUI [1]
C0877658
Ventricular fibrillation
Description

Ventricular Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0042510
Idioventricular rhythm (heart rate < 100 beats/min)
Description

Idioventricular rhythm (heart rate < 100 beats/min)

Data type

boolean

Alias
UMLS CUI [1]
C0700363
Sustained ventricular tachycardia
Description

Sustained ventricular tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C0750197
Non-sustained ventricular tachycardia
Description

Non-sustained ventricular tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C0750194
Wide QRS Tachycardia (diagnosis unknown)
Description

Wide QRS Tachycardia (diagnosis unknown)

Data type

boolean

Alias
UMLS CUI [1]
C0344429
Ventricular tachycardia
Description

Ventricular tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C0042514
Monomorphic ventricular tachycardia
Description

Monomorphic ventricular tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C0344431
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Description

Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)

Data type

boolean

Alias
UMLS CUI [1]
C0040479
Polymorphic (sustained and non-sustained) ventricular tachycardia
Description

Polymorphic (sustained and non-sustained) ventricular tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C0344432
Artificial pacemaker
Description

Artificial pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C0030163
Other abnormal rhythm
Description

Other abnormal rhythm

Data type

boolean

Alias
UMLS CUI [1,1]
C1533266
UMLS CUI [1,2]
C0205394
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0199556
12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology
Description

12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
UMLS CUI-3
C2216025
UMLS CUI-4
C0429098
Left atrial abnormality (P mitrale)
Description

Left atrial abnormality (P mitrale)

Data type

boolean

Alias
UMLS CUI [1,1]
C0344711
UMLS CUI [1,2]
C0232310
Right atrial abnormality (P pulmonale)
Description

Right atrial abnormality (P pulmonale)

Data type

boolean

Alias
UMLS CUI [1,1]
C0344696
UMLS CUI [1,2]
C0232308
Right ventricular hypertrophy
Description

Right ventricular hypertrophy

Data type

boolean

Alias
UMLS CUI [1]
C0162770
Intraatrial conduction delay
Description

Intraatrial conduction delay

Data type

boolean

Alias
UMLS CUI [1]
C2346510
Increased voltage consistent with left ventricular hypertrophy
Description

Increased voltage consistent with left ventricular hypertrophy

Data type

boolean

Alias
UMLS CUI [1]
C1112650
Other morphology
Description

Other morphology

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0332437
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2216025
UMLS CUI [1,3]
C0429098
12-Lead ECG Abnormalities: C. Conduction
Description

12-Lead ECG Abnormalities: C. Conduction

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
UMLS CUI-3
C0232217
First degree AV block (PR interval > 200 msec)
Description

First degree AV block (PR interval > 200 msec)

Data type

boolean

Alias
UMLS CUI [1]
C0085614
Short PR interval
Description

Short PR interval

Data type

boolean

Alias
UMLS CUI [1]
C0520878
Second degree AV block (Mobitz type 1)
Description

Second degree AV block (Mobitz type 1)

Data type

boolean

Alias
UMLS CUI [1]
C0264907
Second degree AV block (Mobitz type 2)
Description

Second degree AV block (Mobitz type 2)

Data type

boolean

Alias
UMLS CUI [1]
C0155700
2:1 AV block
Description

2:1 AV block

Data type

boolean

Alias
UMLS CUI [1]
C2346542
Third degree AV block
Description

Third degree AV block

Data type

boolean

Alias
UMLS CUI [1]
C0151517
Left axis deviation (QRS axis more negative than -30°) than -30°)
Description

Left axis deviation (QRS axis more negative than -30°)

Data type

boolean

Alias
UMLS CUI [1]
C0232297
Right axis deviation (QRS axis more positive than +110°)
Description

Right axis deviation (QRS axis more positive than +110°)

Data type

boolean

Alias
UMLS CUI [1]
C0232296
Incomplete right bundle branch block
Description

Incomplete right bundle branch block

Data type

boolean

Alias
UMLS CUI [1]
C0262525
Incomplete left bundle branch block
Description

Incomplete left bundle branch block

Data type

boolean

Alias
UMLS CUI [1]
C0281878
Right bundle branch block
Description

Right bundle branch block

Data type

boolean

Alias
UMLS CUI [1]
C0085615
Left anterior hemiblock (synonymous to left anterior fascicular block)
Description

Left anterior hemiblock (synonymous to left anterior fascicular block)

Data type

boolean

Alias
UMLS CUI [1]
C0264912
Left posterior hemiblock (synonymous to left posterior fascicular block)
Description

Left posterior hemiblock (synonymous to left posterior fascicular block)

Data type

boolean

Alias
UMLS CUI [1]
C0264913
Left Bundle Branch Block
Description

Left Bundle Branch Block

Data type

boolean

Alias
UMLS CUI [1]
C0023211
Bifascicular block
Description

Bifascicular block

Data type

boolean

Alias
UMLS CUI [1]
C0264914
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
Description

Non-specific intraventricular conduction delay (QRS ≥ 120 msec)

Data type

boolean

Alias
UMLS CUI [1]
C3697597
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Description

Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)

Data type

boolean

Alias
UMLS CUI [1,1]
C0264897
UMLS CUI [1,2]
C0043202
Prolonged QT interval
Description

Prolonged QT interval

Data type

boolean

Alias
UMLS CUI [1]
C0151878
QT/QTc prolongation ≥ 500 msec
Description

QT/QTc prolongation ≥ 500 msec

Data type

boolean

Alias
UMLS CUI [1]
C0855333
AV dissociation
Description

AV dissociation

Data type

boolean

Alias
UMLS CUI [1]
C0004331
Other conduction
Description

Other conduction

Data type

boolean

Alias
UMLS CUI [1,1]
C0232217
UMLS CUI [1,2]
C0205394
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
UMLS CUI [1,4]
C0947611
12-Lead ECG Abnormalities: D. Myocardial Infarction
Description

12-Lead ECG Abnormalities: D. Myocardial Infarction

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
UMLS CUI-3
C0027051
Myocardial infarction, old
Description

Myocardial infarction, old

Data type

boolean

Alias
UMLS CUI [1]
C0155668
Myocardial infarction, anterior
Description

Myocardial infarction, anterior

Data type

boolean

Alias
UMLS CUI [1]
C0340293
Myocardial infarction, lateral
Description

Myocardial infarction, lateral

Data type

boolean

Alias
UMLS CUI [1]
C0340312
Myocardial infarction, posterior
Description

Myocardial infarction, posterior

Data type

boolean

Alias
UMLS CUI [1]
C0340319
Myocardial infarction, inferior
Description

Myocardial infarction, inferior

Data type

boolean

Alias
UMLS CUI [1]
C0340305
Myocardial infarction, septal
Description

Myocardial infarction, septal

Data type

boolean

Alias
UMLS CUI [1]
C0746727
Myocardial infarction, Non-Q wave
Description

Myocardial infarction, Non-Q wave

Data type

boolean

Alias
UMLS CUI [1]
C0542269
Other myocardial infarction
Description

Other myocardial infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0027051
UMLS CUI [1,4]
C0947611
12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)
Description

12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0948857
Non-specific ST-T changes
Description

Non-specific ST-T changes

Data type

boolean

Alias
UMLS CUI [1]
C1112720
J point elevation
Description

J point elevation

Data type

boolean

Alias
UMLS CUI [1]
C2346597
ST elevation
Description

ST elevation

Data type

boolean

Alias
UMLS CUI [1]
C0520886
ST elevation-pericarditis
Description

ST elevation-pericarditis

Data type

boolean

Alias
UMLS CUI [1]
C2348119
ST depression
Description

ST depression

Data type

boolean

Alias
UMLS CUI [1]
C0520887
ST segment abnormality, not specified
Description

ST segment abnormality, not specified

Data type

boolean

Alias
UMLS CUI [1]
C2348120
U waves abnormal
Description

U waves abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438169
T wave inversion
Description

T wave inversion

Data type

boolean

Alias
UMLS CUI [1]
C0520888
T wave peaked
Description

T wave peaked

Data type

boolean

Alias
UMLS CUI [1]
C0239242
T waves flat
Description

T waves flat

Data type

boolean

Alias
UMLS CUI [1]
C2215959
T waves biphasic
Description

T waves biphasic

Data type

boolean

Alias
UMLS CUI [1]
C2348639
Notched T-waves
Description

Notched T-waves

Data type

boolean

Alias
UMLS CUI [1]
C2347367
Low QRS voltage
Description

Low QRS voltage

Data type

boolean

Alias
UMLS CUI [1]
C2349945
T-wave flattening/inversion
Description

T-wave flattening/inversion

Data type

boolean

Alias
UMLS CUI [1,1]
C0520888
UMLS CUI [1,2]
C0429059
T wave abnormality, not specified
Description

T wave abnormality, not specified

Data type

boolean

Alias
UMLS CUI [1]
C0438167
Other depolarisation/repolarisation
Description

Other depolarisation/repolarisation

Data type

boolean

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C0205394
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0948857
UMLS CUI [1,3]
C0947611
12-Lead ECG Abnormalities: Other Abnormalities
Description

12-Lead ECG Abnormalities: Other Abnormalities

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
UMLS CUI-3
C0205394
Other abnormalities
Description

Other abnormalities

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1704258
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0947611
Local laboratory result data (haematology)
Description

Local laboratory result data (haematology)

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0474523
Date and time sample taken
Description

Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Laboratory name
Description

Laboratory name

Data type

text

Alias
UMLS CUI [1]
C1882331
Address
Description

Address

Data type

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Has the subject fasted?
Description

Has the subject fasted?

Data type

text

Alias
UMLS CUI [1]
C0015663
Haemoglobin (Hb)
Description

Haemoglobin (Hb)

Data type

float

Alias
UMLS CUI [1]
C0518015
Haematocrit
Description

Haematocrit

Data type

float

Alias
UMLS CUI [1]
C0018935
Mean cell haemoglobin (MCH)
Description

Mean cell haemoglobin (MCH)

Data type

float

Alias
UMLS CUI [1]
C0369183
Mean cell haemoglobin concentration (MCHC)
Description

Mean cell haemoglobin concentration (MCHC)

Data type

float

Alias
UMLS CUI [1]
C0474535
Red blood cell count (RBC)
Description

Red blood cell count (RBC)

Data type

float

Alias
UMLS CUI [1]
C0014772
White blood cell count (WBC)
Description

White blood cell count (WBC)

Data type

float

Alias
UMLS CUI [1]
C0023508
Platelets
Description

Platelets

Data type

float

Alias
UMLS CUI [1]
C0005821
Lymphocytes
Description

Lymphocytes

Data type

float

Alias
UMLS CUI [1]
C0024264
Neutrophils
Description

Neutrophils

Data type

float

Alias
UMLS CUI [1]
C0948762
Monocytes
Description

Monocytes

Data type

float

Alias
UMLS CUI [1]
C0026473
Basophils
Description

Basophils

Data type

float

Alias
UMLS CUI [1]
C0200641
Eosinophils
Description

Eosinophils

Data type

float

Alias
UMLS CUI [1]
C0362902
Units for differential
Description

Units for differential

Data type

text

Alias
UMLS CUI [1,1]
C1820731
UMLS CUI [1,2]
C1519795
Local laboratory result data - (clinical chemistry)
Description

Local laboratory result data - (clinical chemistry)

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0525044
Date and time sample taken
Description

Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Laboratory name
Description

Laboratory name

Data type

text

Alias
UMLS CUI [1]
C1882331
Address
Description

Address

Data type

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Has the subject fasted?
Description

Has the subject fasted?

Data type

text

Alias
UMLS CUI [1]
C0015663
Sodium
Description

Sodium

Data type

float

Alias
UMLS CUI [1]
C0337443
Potassium
Description

Potassium

Data type

float

Alias
UMLS CUI [1]
C0202194
Urea
Description

Urea

Data type

float

Alias
UMLS CUI [1]
C0523961
Creatinine
Description

Creatinine

Data type

float

Alias
UMLS CUI [1]
C0201976
Total Protein
Description

Total Protein

Data type

float

Alias
UMLS CUI [1]
C0555903
Albumin
Description

Albumin

Data type

float

Alias
UMLS CUI [1]
C0201838
Total Bilirubin
Description

Total Bilirubin

Data type

float

Alias
UMLS CUI [1]
C0201913
Aspartate aminotransferase (AST)
Description

Aspartate aminotransferase (AST)

Data type

float

Alias
UMLS CUI [1]
C0201899
Alanine aminotransferase (ALT)
Description

Alanine aminotransferase (ALT)

Data type

float

Alias
UMLS CUI [1]
C0201836
Alkaline phosphatase (AP)
Description

Alkaline phosphatase (AP)

Data type

float

Alias
UMLS CUI [1]
C0201850
Gamma glutamyl transferase (GGT)
Description

Gamma glutamyl transferase (GGT)

Data type

float

Alias
UMLS CUI [1]
C0202035
Calcium
Description

Calcium

Data type

float

Alias
UMLS CUI [1]
C0201925
Phosphate
Description

Phosphate

Data type

float

Alias
UMLS CUI [1]
C0523826
Cholesterol
Description

Cholesterol

Data type

float

Alias
UMLS CUI [1]
C1445957
Triglycerides
Description

Triglycerides

Data type

float

Alias
UMLS CUI [1]
C0202236
Glucose
Description

Glucose

Data type

float

Alias
UMLS CUI [1]
C0202042
Creatine phosphokinase
Description

Creatine phosphokinase

Data type

float

Alias
UMLS CUI [1]
C0201973
Chloride
Description

Chloride

Data type

float

Alias
UMLS CUI [1]
C0201952
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
Date and time sample taken
Description

Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0200345
Address
Description

Address

Data type

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Urinalysis (Dipstick) Test: pH
Description

Urinalysis (Dipstick) Test: pH

Data type

integer

Alias
UMLS CUI [1]
C0042044
Urinalysis (Dipstick) Test: Protein
Description

Urinalysis (Dipstick) Test: Protein

Data type

float

Alias
UMLS CUI [1]
C0262923
Urinalysis (Dipstick) Test: Glucose
Description

Urinalysis (Dipstick) Test: Glucose

Data type

float

Alias
UMLS CUI [1]
C0004076
Urinalysis (Dipstick) Test: Bilirubin
Description

Urinalysis (Dipstick) Test: Bilirubin

Data type

float

Alias
UMLS CUI [1]
C0042040
Urinalysis (Dipstick) Test: Blood
Description

Urinalysis (Dipstick) Test: Blood

Data type

float

Alias
UMLS CUI [1]
C0202514
Urinalysis (Dipstick) Test: Specific Gravity
Description

Urinalysis (Dipstick) Test: Specific Gravity

Data type

float

Alias
UMLS CUI [1]
C0430383
Was sedimentary microscopy performed?
Description

Was sedimentary microscopy performed?

Data type

text

Alias
UMLS CUI [1]
C2700128
Urinalysis (Microscopy) Test: White blood cells
Description

Urinalysis (Microscopy) Test: White blood cells

Data type

integer

Alias
UMLS CUI [1]
C0919738
Urinalysis (Microscopy) Test: Red blood cells
Description

Urinalysis (Microscopy) Test: Red blood cells

Data type

integer

Alias
UMLS CUI [1]
C0221752
Urinalysis (Microscopy) Test: Hyaline casts
Description

Urinalysis (Microscopy) Test: Hyaline casts

Data type

integer

Alias
UMLS CUI [1]
C1254537
Urinalysis (Microscopy) Test: Granular casts
Description

Urinalysis (Microscopy) Test: Granular casts

Data type

integer

Alias
UMLS CUI [1]
C2697521
Urinalysis (Microscopy) Test: Cellular casts
Description

Urinalysis (Microscopy) Test: Cellular casts

Data type

integer

Alias
UMLS CUI [1]
C2699157
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Description

Did the subject meet all the entry criteria?

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Male or female patients aged between 30 and 85 years of age inclusive at screening.
Description

Male or female patients aged between 30 and 85 years of age inclusive at screening.

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Body mass index of 18 to 32 kg/m2, with a body weight of at least 50 kg
Description

Body mass index of 18 to 32 kg/m2, with a body weight of at least 50 kg

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
Diagnosis of idiopathic Parkinson's Disease graded according to modified Hoehn & Yahr Stage I-III (Appendix 4 of protocol).
Description

Diagnosis of idiopathic Parkinson's Disease graded according to modified Hoehn & Yahr Stage I-III (Appendix 4 of protocol).

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0451215
Patients must have provided written informed consent prior to performing any Screening assessments, including any washout of concomitant medications in preparation for this study.
Description

Patients must have provided written informed consent prior to performing any Screening assessments, including any washout of concomitant medications in preparation for this study.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
QTc interval of < 450ms at screening (or QTc < 480ms in patients with Bundle Branch Block).
Description

QTc interval of < 450ms at screening (or QTc < 480ms in patients with Bundle Branch Block).

Data type

boolean

Alias
UMLS CUI [1]
C0489625
Female patient is currently either of: a) non-childbearingpotential(i.e.,physiologicallyincapableofbecomingpregnant,includingany female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses) OR b) child-bearingpotential,hasanegativeurine/serumpregnancytestattheScreeningVisit(priorto investigational product administration), and agrees to use acceptable contraception from one month prior to study Day 1 until one month after completion of the study (ie. one month after the follow-up visit). All hormonal birth control must have been administered for at least one monthly cycle prior to the Screening Visit. GSK acceptable contraception methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows: • complete abstinence • sterilization of patient's male partner prior to female patient's entry into study • oral contraceptive (either combined or progestogen only) • any intra-uterine device with a documented failure rate of less than 1% per year • systemic contraception (eg. norplant system) • double barrier method if comprised of a spermicide with either a condom or diaphragm.
Description

Childbearing potential

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Patients who have an abnormality on physical examination. A patient with clinical abnormality may be included only if the Investigator considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedures.
Description

Clinical abnormality

Data type

boolean

Alias
UMLS CUI [1,1]
C0747585
UMLS CUI [1,2]
C0035648
Patients who, in the opinion of the Investigator, have medical conditions which could present a safety concern. These may include, but are not limited to, the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, hepatic or renal failure, pleuro-pulmonary fibrosis, significant and/or uncontrolled psychiatric, haematological, endocrinological, neurological (other than Parkinson's disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrhythmias, cerebrovascular accident (CVA), or patients who are known to have malignancy, are being treated for malignancy or have had treatment for malignancy within the last year (other than basal cell cancer).
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0009488
Patients having a clinically significant abnormal laboratory value, ECG, or physical examination findings not resolved by the time of the baseline examinations. Abnormal 12-lead ECG findings include, but are not limited to, the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias.
Description

clinically significant abnormal laboratory value, ECG, or physical examination findings

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0522055
UMLS CUI [3]
C0747585
Positive result for Hepatitis B surface antigen, Hepatitis C antibody or Human Immunodeficiency Virus (HIV) antibody at screening.
Description

Positive result for Hepatitis B surface antigen, Hepatitis C antibody or Human Immunodeficiency Virus (HIV) antibody at screening.

Data type

boolean

Alias
UMLS CUI [1,1]
C0281863
UMLS CUI [1,2]
C0149709
UMLS CUI [1,3]
C0920548
Positive alcohol test result and / or urine test for undeclared drugs at screening.
Description

Positive alcohol test result and / or urine test for undeclared drugs at screening.

Data type

boolean

Alias
UMLS CUI [1,1]
C0948726
UMLS CUI [1,2]
C0743300
Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure, after rising from the supine to erect posture, of > 30 mmHg for systolic pressure and > 20 mmHg for diastolic pressure.
Description

history of moderate to severe dizziness, syncope, or orthostatic hypotension

Data type

boolean

Alias
UMLS CUI [1,1]
C0012833
UMLS CUI [1,2]
C0039070
UMLS CUI [1,3]
C0020651
Significant sleep disorder or Epworth Sleep Score (Appendix 5) ≥9 at screening.
Description

Significant sleep disorder or Epworth Sleep Score (Appendix 5) ≥9 at screening.

Data type

boolean

Alias
UMLS CUI [1,1]
C0851578
UMLS CUI [1,2]
C2129304
Patients with a lying/sitting diastolic blood pressure ≥110mmHg or ≤50mmHg or a systolic blood pressure ≥180mmHg or ≤90mmHg at the Screening or Baseline Visit.
Description

Patients with a lying/sitting diastolic blood pressure ≥110mmHg or ≤50mmHg or a systolic blood pressure ≥180mmHg or ≤90mmHg at the Screening or Baseline Visit.

Data type

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0428883
History of any dopaminergic treatment (other than ropinirole IR and L-dopa) within 2 weeks prior to first dose. • Patients on dopaminergic agonists other than ropinirole IR and L-dopa may be enrolled if the agent is stopped for a 2-week wash-out period prior to first dose. • Patients taking ropinirole IR or L-dopa may switch to ropinirole PR/CR 2mg on study day 1, providing they have first followed the manufacturer's down titration guidelines. • Patients taking ropinirole IR > 4mg/day must be down-titrated according to the manufacturer's guidelines prior to study day 1. • Patients taking ropinirole IR or L-dopa must have been on a stable dose for at least 4 weeks prior to screening; doses of ropinirole IR or L-dopa may need to be adjusted prior to or during the study. • Patients on selegiline, amantadine, or anticholinergics may be enrolled but must have been on a stable dose for at least one month prior to study enrolment and must remain on their current dose throughout the treatment phase of the study.
Description

Concomtant medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0013036
UMLS CUI [1,2]
C2347852
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, ciprofloxacin, fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 7 days prior to study enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent for at least one month prior to enrolment and throughout the treatment phase of the study.
Description

Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, ciprofloxacin, fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 7 days prior to study enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent for at least one month prior to enrolment and throughout the treatment phase of the study.

Data type

boolean

Alias
UMLS CUI [1,1]
C0282402
UMLS CUI [1,2]
C0207509
Patients who smoke >20 cigarettes per day and will not maintain a constant smoking habit for the duration of the study.
Description

Patients who smoke >20 cigarettes per day and will not maintain a constant smoking habit for the duration of the study.

Data type

boolean

Alias
UMLS CUI [1]
C0453996
Blood donation or significant blood loss less than 90 days before Day 1 of the current study.
Description

Blood donation or significant blood loss less than 90 days before Day 1 of the current study.

Data type

boolean

Alias
UMLS CUI [1,1]
C3163616
UMLS CUI [1,2]
C0005794
Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure.
Description

Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure.

Data type

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0244821
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0244821
Use of any investigational drug (with the exception of ropinirole PR/CR) within 30 days or 5 half lives (whichever is longer) before the start of dosing with study medication.
Description

Use of any investigational drug (with the exception of ropinirole PR/CR) within 30 days or 5 half lives (whichever is longer) before the start of dosing with study medication.

Data type

boolean

Alias
UMLS CUI [1]
C0013230
Patients who have received over-the-counter (OTC) medicine within 48 h before the first dose of study drug. Patients who have taken OTC medication may still be entered in the study, if in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
Description

Patients who have received over-the-counter (OTC) medicine within 48 h before the first dose of study drug. Patients who have taken OTC medication may still be entered in the study, if in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.

Data type

boolean

Alias
UMLS CUI [1]
C0013231
Recent history, or suspicion, of drug dependence or abuse of alcohol (with alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women. One unit is equivalent to half a pint of beer, one measure of spirits, or one glass of wine).
Description

drug dependence or abuse of alcohol

Data type

boolean

Alias
UMLS CUI [1,1]
C1510472
UMLS CUI [1,2]
C0085762
Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.
Description

Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0422727
UMLS CUI [3]
C2347852
Women who are pregnant or breast-feeding.
Description

Women who are pregnant or breast-feeding.

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Patients with prior or current major psychosis (eg schizophrenia or psychotic depression). Eg scoring 3 or 4 on UPDRS item 2 [thought disorder] or item 3 [depression].
Description

Patients with prior or current major psychosis (eg schizophrenia or psychotic depression). Eg scoring 3 or 4 on UPDRS item 2 [thought disorder] or item 3 [depression].

Data type

boolean

Alias
UMLS CUI [1]
C0033975
Investigator Comment Log
Description

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF page number if applicable
Description

CRF page number if applicable

Data type

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
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Similar models

Screening Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject Information
C2707520 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic Ancestry
text
C0034510 (UMLS CUI [1])
Geographic Ancestry
Code List
Geographic Ancestry
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Child-bearing Potential (Complete for Female Subjects Only)
C1960468 (UMLS CUI-1)
Item
Child-bearing Potential: Check one
text
C1960468 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
Child-bearing Potential: Check one
Code List
Child-bearing Potential: Check one
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item Group
Pregnancy Test (Complete for Female Subjects of Child-bearing Potential Only)
C0032976 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C0011008 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item
Results
text
C0587081 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Results
Code List
Results
CL Item
Positive (If positive, exclude subject from the study.) (1)
CL Item
Negative (2)
Item Group
Local Laboratory Result Data
C1254595 (UMLS CUI-1)
FSH/LH Result
Item
FSH/LH Result
text
C1254595 (UMLS CUI [1,1])
C2122182 (UMLS CUI [1,2])
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
C0009488 (UMLS CUI-2)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Current
Item
Current
boolean
C0521116 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Past
Item
Past
boolean
C1444637 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Item Group
Urine Drug Screen
C0202274 (UMLS CUI-1)
Date and time of sample taken
Item
Date and time of sample taken
datetime
C0202274 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Amphetamines
text
C0002667 (UMLS CUI [1])
Amphetamines
Code List
Amphetamines
CL Item
positive (1)
CL Item
negative (2)
Item
Barbiturates
text
C0004745 (UMLS CUI [1])
Barbiturates
Code List
Barbiturates
CL Item
positive (1)
CL Item
negative (2)
Item
Cannabis
text
C0936079 (UMLS CUI [1])
Cannabis
Code List
Cannabis
CL Item
positive (1)
CL Item
negative (2)
Item
Cocaine
text
C0009170 (UMLS CUI [1])
Cocaine
Code List
Cocaine
CL Item
positive (1)
CL Item
negative (2)
Item
Morphine and derivatives
text
C0279996 (UMLS CUI [1])
Morphine and derivatives
Code List
Morphine and derivatives
CL Item
positive (1)
CL Item
negative (2)
Item Group
Alcohol Test
C0868676 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C0011008 (UMLS CUI [1,1])
C0868676 (UMLS CUI [1,2])
Item
Results, check one
text
C0587081 (UMLS CUI [1,1])
C0868676 (UMLS CUI [1,2])
Results, check one
Code List
Results, check one
CL Item
Positive (If positive, exclude subject from the study) (1)
CL Item
Negative (2)
Item Group
Serology - HIV/Hepatitis Screen
C0459958 (UMLS CUI-1)
C1445958 (UMLS CUI-2)
Date sample taken
Item
Date sample taken
date
C0459958 (UMLS CUI [1,1])
C1445958 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Item
HIV antibody
text
C0019683 (UMLS CUI [1])
HIV antibody
Code List
HIV antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis B surface antigen
text
C0019168 (UMLS CUI [1])
Hepatitis B surface antigen
Code List
Hepatitis B surface antigen
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis C antibody
text
C0281863 (UMLS CUI [1])
Hepatitis C antibody
Code List
Hepatitis C antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Hair and skin
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
Hair and skin
Code List
Hair and skin
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Lymph nodes
text
C0024204 (UMLS CUI [1])
Lymph nodes
Code List
Lymph nodes
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Eyes
text
C0200149 (UMLS CUI [1])
Eyes
Code List
Eyes
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Ears, Nose and Throat
text
C0278350 (UMLS CUI [1])
Ears, Nose and Throat
Code List
Ears, Nose and Throat
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Breasts
text
C0199850 (UMLS CUI [1])
Breasts
Code List
Breasts
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Respiratory
text
C0436121 (UMLS CUI [1])
Respiratory
Code List
Respiratory
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Cardiovascular
text
C3854344 (UMLS CUI [1])
Cardiovascular
Code List
Cardiovascular
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Abdomen
text
C0562238 (UMLS CUI [1])
Abdomen
Code List
Abdomen
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Urogenital
text
C1828035 (UMLS CUI [1])
Urogenital
Code List
Urogenital
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Pelvic
text
C0200045 (UMLS CUI [1])
Pelvic
Code List
Pelvic
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Rectal
text
C0199900 (UMLS CUI [1])
Rectal
Code List
Rectal
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Musculoskeletal
text
C0475091 (UMLS CUI [1])
Musculoskeletal
Code List
Musculoskeletal
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Neurological
text
C0027853 (UMLS CUI [1])
Neurological
Code List
Neurological
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Mental Status
text
C0278060 (UMLS CUI [1])
Mental Status
Code List
Mental Status
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item Group
History of tobacco use
C0841002 (UMLS CUI-1)
Item
What is the subject's history of tobacco use?
text
C0841002 (UMLS CUI [1])
What is the subject's history of tobacco use?
Code List
What is the subject's history of tobacco use?
CL Item
Never smoked (1)
CL Item
Current smoker (2)
CL Item
Former Smoker (3)
If former smoker: When did the subject last smoke/use tobacco?
Item
If former smoker: When did the subject last smoke/use tobacco?
date
C0543414 (UMLS CUI [1])
If current or former smoker, answer the following question: Number of cigarettes smoked per day?
Item
If current or former smoker, answer the following question: Number of cigarettes smoked per day?
integer
C3694146 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Mass Index
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Date
Item
Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Screening (1)
CL Item
Unscheduled (2)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject position
text
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Subject position
Code List
Subject position
CL Item
Supine (1)
CL Item
Standing (3)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Start date of ECG
Item
Start date of ECG
date
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Screening (1)
CL Item
Unscheduled (2)
Start Time of ECG
Item
Start Time of ECG
time
C1301880 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
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
C0489625 (UMLS CUI [1])
Item
Result of the ECG
text
C0438154 (UMLS CUI [1])
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)
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities: A. Rhythm
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0199556 (UMLS CUI-3)
Sinus bradycardia
Item
Sinus bradycardia
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (heart rate 40-50 beats/min)
Item
Sinus bradycardia (heart rate 40-50 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (heart rate 30-39 beats/min)
Item
Sinus bradycardia (heart rate 30-39 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (heart rate < 30 beats/min)
Item
Sinus bradycardia (heart rate < 30 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus pause
Item
Sinus pause
boolean
C1955864 (UMLS CUI [1])
Sinus tachycardia (heart rate >100 beats/min)
Item
Sinus tachycardia (heart rate >100 beats/min)
boolean
C0039239 (UMLS CUI [1])
Ectopic supraventricular beats
Item
Ectopic supraventricular beats
boolean
C0033036 (UMLS CUI [1])
Ectopic supraventricular rhythm
Item
Ectopic supraventricular rhythm
boolean
C2348376 (UMLS CUI [1])
Wandering atrial pacemaker
Item
Wandering atrial pacemaker
boolean
C1321523 (UMLS CUI [1])
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
boolean
C0221158 (UMLS CUI [1])
Supraventricular tachycardia (heart rate >100 beats/min)
Item
Supraventricular tachycardia (heart rate >100 beats/min)
boolean
C0039240 (UMLS CUI [1])
Atrial flutter
Item
Atrial flutter
boolean
C0004239 (UMLS CUI [1])
Atrial Fibrillation
Item
Atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Junctional rhythm (heart rate ≤100 beats/min)
Item
Junctional rhythm (heart rate ≤100 beats/min)
boolean
C0232208 (UMLS CUI [1])
Junctional rhythm
Item
Junctional rhythm
boolean
C0232208 (UMLS CUI [1])
Junctional tachycardia (heart rate > 100 beats/min)
Item
Junctional tachycardia (heart rate > 100 beats/min)
boolean
C0039235 (UMLS CUI [1])
Ectopic ventricular beats
Item
Ectopic ventricular beats
boolean
C0151636 (UMLS CUI [1])
Ventricular couplets
Item
Ventricular couplets
boolean
C0429001 (UMLS CUI [1])
Bigeminy
Item
Bigeminy
boolean
C0262662 (UMLS CUI [1])
Trigeminy
Item
Trigeminy
boolean
C0428999 (UMLS CUI [1])
Electrical alternans
Item
Electrical alternans
boolean
C1142551 (UMLS CUI [1])
R on T phenomenon
Item
R on T phenomenon
boolean
C0877658 (UMLS CUI [1])
Ventricular Fibrillation
Item
Ventricular fibrillation
boolean
C0042510 (UMLS CUI [1])
Idioventricular rhythm (heart rate < 100 beats/min)
Item
Idioventricular rhythm (heart rate < 100 beats/min)
boolean
C0700363 (UMLS CUI [1])
Sustained ventricular tachycardia
Item
Sustained ventricular tachycardia
boolean
C0750197 (UMLS CUI [1])
Non-sustained ventricular tachycardia
Item
Non-sustained ventricular tachycardia
boolean
C0750194 (UMLS CUI [1])
Wide QRS Tachycardia (diagnosis unknown)
Item
Wide QRS Tachycardia (diagnosis unknown)
boolean
C0344429 (UMLS CUI [1])
Ventricular tachycardia
Item
Ventricular tachycardia
boolean
C0042514 (UMLS CUI [1])
Monomorphic ventricular tachycardia
Item
Monomorphic ventricular tachycardia
boolean
C0344431 (UMLS CUI [1])
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
boolean
C0040479 (UMLS CUI [1])
Polymorphic (sustained and non-sustained) ventricular tachycardia
Item
Polymorphic (sustained and non-sustained) ventricular tachycardia
boolean
C0344432 (UMLS CUI [1])
Artificial pacemaker
Item
Artificial pacemaker
boolean
C0030163 (UMLS CUI [1])
Other abnormal rhythm
Item
Other abnormal rhythm
boolean
C1533266 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C2216025 (UMLS CUI-3)
C0429098 (UMLS CUI-4)
Left atrial abnormality (P mitrale)
Item
Left atrial abnormality (P mitrale)
boolean
C0344711 (UMLS CUI [1,1])
C0232310 (UMLS CUI [1,2])
Right atrial abnormality (P pulmonale)
Item
Right atrial abnormality (P pulmonale)
boolean
C0344696 (UMLS CUI [1,1])
C0232308 (UMLS CUI [1,2])
Right ventricular hypertrophy
Item
Right ventricular hypertrophy
boolean
C0162770 (UMLS CUI [1])
Intraatrial conduction delay
Item
Intraatrial conduction delay
boolean
C2346510 (UMLS CUI [1])
Increased voltage consistent with left ventricular hypertrophy
Item
Increased voltage consistent with left ventricular hypertrophy
boolean
C1112650 (UMLS CUI [1])
Other morphology
Item
Other morphology
boolean
C0205394 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C2216025 (UMLS CUI [1,2])
C0429098 (UMLS CUI [1,3])
Item Group
12-Lead ECG Abnormalities: C. Conduction
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0232217 (UMLS CUI-3)
First degree AV block (PR interval > 200 msec)
Item
First degree AV block (PR interval > 200 msec)
boolean
C0085614 (UMLS CUI [1])
Short PR interval
Item
Short PR interval
boolean
C0520878 (UMLS CUI [1])
Second degree AV block (Mobitz type 1)
Item
Second degree AV block (Mobitz type 1)
boolean
C0264907 (UMLS CUI [1])
Second degree AV block (Mobitz type 2)
Item
Second degree AV block (Mobitz type 2)
boolean
C0155700 (UMLS CUI [1])
2:1 AV block
Item
2:1 AV block
boolean
C2346542 (UMLS CUI [1])
Third degree AV block
Item
Third degree AV block
boolean
C0151517 (UMLS CUI [1])
Left axis deviation (QRS axis more negative than -30°)
Item
Left axis deviation (QRS axis more negative than -30°) than -30°)
boolean
C0232297 (UMLS CUI [1])
Right axis deviation (QRS axis more positive than +110°)
Item
Right axis deviation (QRS axis more positive than +110°)
boolean
C0232296 (UMLS CUI [1])
Incomplete right bundle branch block
Item
Incomplete right bundle branch block
boolean
C0262525 (UMLS CUI [1])
Incomplete left bundle branch block
Item
Incomplete left bundle branch block
boolean
C0281878 (UMLS CUI [1])
Right bundle branch block
Item
Right bundle branch block
boolean
C0085615 (UMLS CUI [1])
Left anterior hemiblock (synonymous to left anterior fascicular block)
Item
Left anterior hemiblock (synonymous to left anterior fascicular block)
boolean
C0264912 (UMLS CUI [1])
Left posterior hemiblock (synonymous to left posterior fascicular block)
Item
Left posterior hemiblock (synonymous to left posterior fascicular block)
boolean
C0264913 (UMLS CUI [1])
Left Bundle Branch Block
Item
Left Bundle Branch Block
boolean
C0023211 (UMLS CUI [1])
Bifascicular block
Item
Bifascicular block
boolean
C0264914 (UMLS CUI [1])
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
boolean
C3697597 (UMLS CUI [1])
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
boolean
C0264897 (UMLS CUI [1,1])
C0043202 (UMLS CUI [1,2])
Prolonged QT interval
Item
Prolonged QT interval
boolean
C0151878 (UMLS CUI [1])
QT/QTc prolongation ≥ 500 msec
Item
QT/QTc prolongation ≥ 500 msec
boolean
C0855333 (UMLS CUI [1])
AV dissociation
Item
AV dissociation
boolean
C0004331 (UMLS CUI [1])
Other conduction
Item
Other conduction
boolean
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Item Group
12-Lead ECG Abnormalities: D. Myocardial Infarction
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0027051 (UMLS CUI-3)
Myocardial infarction, old
Item
Myocardial infarction, old
boolean
C0155668 (UMLS CUI [1])
Myocardial infarction, anterior
Item
Myocardial infarction, anterior
boolean
C0340293 (UMLS CUI [1])
Myocardial infarction, lateral
Item
Myocardial infarction, lateral
boolean
C0340312 (UMLS CUI [1])
Myocardial infarction, posterior
Item
Myocardial infarction, posterior
boolean
C0340319 (UMLS CUI [1])
Myocardial infarction, inferior
Item
Myocardial infarction, inferior
boolean
C0340305 (UMLS CUI [1])
Myocardial infarction, septal
Item
Myocardial infarction, septal
boolean
C0746727 (UMLS CUI [1])
Myocardial infarction, Non-Q wave
Item
Myocardial infarction, Non-Q wave
boolean
C0542269 (UMLS CUI [1])
Other myocardial infarction
Item
Other myocardial infarction
boolean
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Item Group
12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)
C0430456 (UMLS CUI-1)
C0948857 (UMLS CUI-2)
Non-specific ST-T changes
Item
Non-specific ST-T changes
boolean
C1112720 (UMLS CUI [1])
J point elevation
Item
J point elevation
boolean
C2346597 (UMLS CUI [1])
ST elevation
Item
ST elevation
boolean
C0520886 (UMLS CUI [1])
ST elevation-pericarditis
Item
ST elevation-pericarditis
boolean
C2348119 (UMLS CUI [1])
ST depression
Item
ST depression
boolean
C0520887 (UMLS CUI [1])
ST segment abnormality, not specified
Item
ST segment abnormality, not specified
boolean
C2348120 (UMLS CUI [1])
U waves abnormal
Item
U waves abnormal
boolean
C0438169 (UMLS CUI [1])
T wave inversion
Item
T wave inversion
boolean
C0520888 (UMLS CUI [1])
T wave peaked
Item
T wave peaked
boolean
C0239242 (UMLS CUI [1])
T waves flat
Item
T waves flat
boolean
C2215959 (UMLS CUI [1])
T waves biphasic
Item
T waves biphasic
boolean
C2348639 (UMLS CUI [1])
Notched T-waves
Item
Notched T-waves
boolean
C2347367 (UMLS CUI [1])
Low QRS voltage
Item
Low QRS voltage
boolean
C2349945 (UMLS CUI [1])
T-wave flattening/inversion
Item
T-wave flattening/inversion
boolean
C0520888 (UMLS CUI [1,1])
C0429059 (UMLS CUI [1,2])
T wave abnormality, not specified
Item
T wave abnormality, not specified
boolean
C0438167 (UMLS CUI [1])
Other depolarisation/repolarisation
Item
Other depolarisation/repolarisation
boolean
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
12-Lead ECG Abnormalities: Other Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Other abnormalities
Item
Other abnormalities
boolean
C0205394 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Item Group
Local laboratory result data (haematology)
C1254595 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Item
Has the subject fasted?
text
C0015663 (UMLS CUI [1])
Has the subject fasted?
Code List
Has the subject fasted?
CL Item
No (N)
CL Item
Yes (Y)
Haemoglobin (Hb)
Item
Haemoglobin (Hb)
float
C0518015 (UMLS CUI [1])
Haematocrit
Item
Haematocrit
float
C0018935 (UMLS CUI [1])
Mean cell haemoglobin (MCH)
Item
Mean cell haemoglobin (MCH)
float
C0369183 (UMLS CUI [1])
Mean cell haemoglobin concentration (MCHC)
Item
Mean cell haemoglobin concentration (MCHC)
float
C0474535 (UMLS CUI [1])
Red blood cell count (RBC)
Item
Red blood cell count (RBC)
float
C0014772 (UMLS CUI [1])
White blood cell count (WBC)
Item
White blood cell count (WBC)
float
C0023508 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
float
C0024264 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0948762 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
float
C0362902 (UMLS CUI [1])
Item
Units for differential
text
C1820731 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Units for differential
Code List
Units for differential
CL Item
Percent (1)
CL Item
Absolute count (2)
Item Group
Local laboratory result data - (clinical chemistry)
C1254595 (UMLS CUI-1)
C0525044 (UMLS CUI-2)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Item
Has the subject fasted?
text
C0015663 (UMLS CUI [1])
Has the subject fasted?
Code List
Has the subject fasted?
CL Item
No (N)
CL Item
Yes (Y)
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
Aspartate aminotransferase (AST)
Item
Aspartate aminotransferase (AST)
float
C0201899 (UMLS CUI [1])
Alanine aminotransferase (ALT)
Item
Alanine aminotransferase (ALT)
float
C0201836 (UMLS CUI [1])
Alkaline phosphatase (AP)
Item
Alkaline phosphatase (AP)
float
C0201850 (UMLS CUI [1])
Gamma glutamyl transferase (GGT)
Item
Gamma glutamyl transferase (GGT)
float
C0202035 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Phosphate
Item
Phosphate
float
C0523826 (UMLS CUI [1])
Cholesterol
Item
Cholesterol
float
C1445957 (UMLS CUI [1])
Triglycerides
Item
Triglycerides
float
C0202236 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Creatine phosphokinase
Item
Creatine phosphokinase
float
C0201973 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Date and time sample taken
Item
Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,4])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Urinalysis (Dipstick) Test: pH
Item
Urinalysis (Dipstick) Test: pH
integer
C0042044 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Protein
Item
Urinalysis (Dipstick) Test: Protein
float
C0262923 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Glucose
Item
Urinalysis (Dipstick) Test: Glucose
float
C0004076 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Bilirubin
Item
Urinalysis (Dipstick) Test: Bilirubin
float
C0042040 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Blood
Item
Urinalysis (Dipstick) Test: Blood
float
C0202514 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Specific Gravity
Item
Urinalysis (Dipstick) Test: Specific Gravity
float
C0430383 (UMLS CUI [1])
Item
Was sedimentary microscopy performed?
text
C2700128 (UMLS CUI [1])
Was sedimentary microscopy performed?
Code List
Was sedimentary microscopy performed?
CL Item
No (N)
CL Item
Yes (Y)
Urinalysis (Microscopy) Test: White blood cells
Item
Urinalysis (Microscopy) Test: White blood cells
integer
C0919738 (UMLS CUI [1])
Urinalysis (Microscopy) Test: Red blood cells
Item
Urinalysis (Microscopy) Test: Red blood cells
integer
C0221752 (UMLS CUI [1])
Urinalysis (Microscopy) Test: Hyaline casts
Item
Urinalysis (Microscopy) Test: Hyaline casts
integer
C1254537 (UMLS CUI [1])
Urinalysis (Microscopy) Test: Granular casts
Item
Urinalysis (Microscopy) Test: Granular casts
integer
C2697521 (UMLS CUI [1])
Urinalysis (Microscopy) Test: Cellular casts
Item
Urinalysis (Microscopy) Test: Cellular casts
integer
C2699157 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Male or female patients aged between 30 and 85 years of age inclusive at screening.
Item
Male or female patients aged between 30 and 85 years of age inclusive at screening.
boolean
C0001779 (UMLS CUI [1])
Body mass index of 18 to 32 kg/m2, with a body weight of at least 50 kg
Item
Body mass index of 18 to 32 kg/m2, with a body weight of at least 50 kg
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Diagnosis of idiopathic Parkinson's Disease graded according to modified Hoehn & Yahr Stage I-III (Appendix 4 of protocol).
Item
Diagnosis of idiopathic Parkinson's Disease graded according to modified Hoehn & Yahr Stage I-III (Appendix 4 of protocol).
boolean
C0011900 (UMLS CUI [1,1])
C0451215 (UMLS CUI [1,2])
Patients must have provided written informed consent prior to performing any Screening assessments, including any washout of concomitant medications in preparation for this study.
Item
Patients must have provided written informed consent prior to performing any Screening assessments, including any washout of concomitant medications in preparation for this study.
boolean
C0021430 (UMLS CUI [1])
QTc interval of < 450ms at screening (or QTc < 480ms in patients with Bundle Branch Block).
Item
QTc interval of < 450ms at screening (or QTc < 480ms in patients with Bundle Branch Block).
boolean
C0489625 (UMLS CUI [1])
Childbearing potential
Item
Female patient is currently either of: a) non-childbearingpotential(i.e.,physiologicallyincapableofbecomingpregnant,includingany female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses) OR b) child-bearingpotential,hasanegativeurine/serumpregnancytestattheScreeningVisit(priorto investigational product administration), and agrees to use acceptable contraception from one month prior to study Day 1 until one month after completion of the study (ie. one month after the follow-up visit). All hormonal birth control must have been administered for at least one monthly cycle prior to the Screening Visit. GSK acceptable contraception methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows: • complete abstinence • sterilization of patient's male partner prior to female patient's entry into study • oral contraceptive (either combined or progestogen only) • any intra-uterine device with a documented failure rate of less than 1% per year • systemic contraception (eg. norplant system) • double barrier method if comprised of a spermicide with either a condom or diaphragm.
boolean
C3831118 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Clinical abnormality
Item
Patients who have an abnormality on physical examination. A patient with clinical abnormality may be included only if the Investigator considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedures.
boolean
C0747585 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
Comorbidity
Item
Patients who, in the opinion of the Investigator, have medical conditions which could present a safety concern. These may include, but are not limited to, the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, hepatic or renal failure, pleuro-pulmonary fibrosis, significant and/or uncontrolled psychiatric, haematological, endocrinological, neurological (other than Parkinson's disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrhythmias, cerebrovascular accident (CVA), or patients who are known to have malignancy, are being treated for malignancy or have had treatment for malignancy within the last year (other than basal cell cancer).
boolean
C0012634 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
clinically significant abnormal laboratory value, ECG, or physical examination findings
Item
Patients having a clinically significant abnormal laboratory value, ECG, or physical examination findings not resolved by the time of the baseline examinations. Abnormal 12-lead ECG findings include, but are not limited to, the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias.
boolean
C0438215 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
C0747585 (UMLS CUI [3])
Positive result for Hepatitis B surface antigen, Hepatitis C antibody or Human Immunodeficiency Virus (HIV) antibody at screening.
Item
Positive result for Hepatitis B surface antigen, Hepatitis C antibody or Human Immunodeficiency Virus (HIV) antibody at screening.
boolean
C0281863 (UMLS CUI [1,1])
C0149709 (UMLS CUI [1,2])
C0920548 (UMLS CUI [1,3])
Positive alcohol test result and / or urine test for undeclared drugs at screening.
Item
Positive alcohol test result and / or urine test for undeclared drugs at screening.
boolean
C0948726 (UMLS CUI [1,1])
C0743300 (UMLS CUI [1,2])
history of moderate to severe dizziness, syncope, or orthostatic hypotension
Item
Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure, after rising from the supine to erect posture, of > 30 mmHg for systolic pressure and > 20 mmHg for diastolic pressure.
boolean
C0012833 (UMLS CUI [1,1])
C0039070 (UMLS CUI [1,2])
C0020651 (UMLS CUI [1,3])
Significant sleep disorder or Epworth Sleep Score (Appendix 5) ≥9 at screening.
Item
Significant sleep disorder or Epworth Sleep Score (Appendix 5) ≥9 at screening.
boolean
C0851578 (UMLS CUI [1,1])
C2129304 (UMLS CUI [1,2])
Patients with a lying/sitting diastolic blood pressure ≥110mmHg or ≤50mmHg or a systolic blood pressure ≥180mmHg or ≤90mmHg at the Screening or Baseline Visit.
Item
Patients with a lying/sitting diastolic blood pressure ≥110mmHg or ≤50mmHg or a systolic blood pressure ≥180mmHg or ≤90mmHg at the Screening or Baseline Visit.
boolean
C0871470 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Concomtant medication
Item
History of any dopaminergic treatment (other than ropinirole IR and L-dopa) within 2 weeks prior to first dose. • Patients on dopaminergic agonists other than ropinirole IR and L-dopa may be enrolled if the agent is stopped for a 2-week wash-out period prior to first dose. • Patients taking ropinirole IR or L-dopa may switch to ropinirole PR/CR 2mg on study day 1, providing they have first followed the manufacturer's down titration guidelines. • Patients taking ropinirole IR > 4mg/day must be down-titrated according to the manufacturer's guidelines prior to study day 1. • Patients taking ropinirole IR or L-dopa must have been on a stable dose for at least 4 weeks prior to screening; doses of ropinirole IR or L-dopa may need to be adjusted prior to or during the study. • Patients on selegiline, amantadine, or anticholinergics may be enrolled but must have been on a stable dose for at least one month prior to study enrolment and must remain on their current dose throughout the treatment phase of the study.
boolean
C0013036 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, ciprofloxacin, fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 7 days prior to study enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent for at least one month prior to enrolment and throughout the treatment phase of the study.
Item
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, ciprofloxacin, fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 7 days prior to study enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent for at least one month prior to enrolment and throughout the treatment phase of the study.
boolean
C0282402 (UMLS CUI [1,1])
C0207509 (UMLS CUI [1,2])
Patients who smoke >20 cigarettes per day and will not maintain a constant smoking habit for the duration of the study.
Item
Patients who smoke >20 cigarettes per day and will not maintain a constant smoking habit for the duration of the study.
boolean
C0453996 (UMLS CUI [1])
Blood donation or significant blood loss less than 90 days before Day 1 of the current study.
Item
Blood donation or significant blood loss less than 90 days before Day 1 of the current study.
boolean
C3163616 (UMLS CUI [1,1])
C0005794 (UMLS CUI [1,2])
Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure.
Item
Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure.
boolean
C0559546 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0244821 (UMLS CUI [2,2])
Use of any investigational drug (with the exception of ropinirole PR/CR) within 30 days or 5 half lives (whichever is longer) before the start of dosing with study medication.
Item
Use of any investigational drug (with the exception of ropinirole PR/CR) within 30 days or 5 half lives (whichever is longer) before the start of dosing with study medication.
boolean
C0013230 (UMLS CUI [1])
Patients who have received over-the-counter (OTC) medicine within 48 h before the first dose of study drug. Patients who have taken OTC medication may still be entered in the study, if in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
Item
Patients who have received over-the-counter (OTC) medicine within 48 h before the first dose of study drug. Patients who have taken OTC medication may still be entered in the study, if in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
boolean
C0013231 (UMLS CUI [1])
drug dependence or abuse of alcohol
Item
Recent history, or suspicion, of drug dependence or abuse of alcohol (with alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women. One unit is equivalent to half a pint of beer, one measure of spirits, or one glass of wine).
boolean
C1510472 (UMLS CUI [1,1])
C0085762 (UMLS CUI [1,2])
Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.
Item
Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.
boolean
C1321605 (UMLS CUI [1])
C0422727 (UMLS CUI [2])
C2347852 (UMLS CUI [3])
Women who are pregnant or breast-feeding.
Item
Women who are pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Patients with prior or current major psychosis (eg schizophrenia or psychotic depression). Eg scoring 3 or 4 on UPDRS item 2 [thought disorder] or item 3 [depression].
Item
Patients with prior or current major psychosis (eg schizophrenia or psychotic depression). Eg scoring 3 or 4 on UPDRS item 2 [thought disorder] or item 3 [depression].
boolean
C0033975 (UMLS CUI [1])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF page number if applicable
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
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