Informazione:
Errore:
ID
43527
Descrizione
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
collegamento
https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1
Keywords
versioni (2)
- 25/04/17 25/04/17 -
- 20/09/21 20/09/21 -
Caricato su
20 settembre 2021
DOI
Per favore, per richiedere un accesso.
Licenza
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
Screening Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Similar models
Screening Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
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])
C0220908 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
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])
C0015895 (UMLS CUI [1,2])
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])
C0032976 (UMLS CUI [1,2])
CL Item
Positive (If positive, exclude subject from the study.) (1)
CL Item
Negative (2)
FSH/LH Result
Item
FSH/LH Result
text
C1254595 (UMLS CUI [1,1])
C2122182 (UMLS CUI [1,2])
C2122182 (UMLS CUI [1,2])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Current
Item
Current
boolean
C0521116 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
Past
Item
Past
boolean
C1444637 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
Date sample taken
Item
Date sample taken
date
C0011008 (UMLS CUI [1,1])
C0868676 (UMLS CUI [1,2])
C0868676 (UMLS CUI [1,2])
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)
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])
C1445958 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
What is the subject's history of tobacco use?
text
C0841002 (UMLS CUI [1])
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])
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])
C0011008 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
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])
CL Item
Supine (1)
CL Item
Standing (3)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Start date of ECG
Item
Start date of ECG
date
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
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])
C0013798 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
C2189285 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
QTC interval
Item
QTC interval
integer
C0489625 (UMLS CUI [1])
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)
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])
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)
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])
C0205394 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
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)
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])
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])
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])
C0332437 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C2216025 (UMLS CUI [1,2])
C0429098 (UMLS CUI [1,3])
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)
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])
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])
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])
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)
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])
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])
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)
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])
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])
C0205394 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
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)
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])
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])
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)
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])
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])
C0022877 (UMLS CUI [1,2])
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])
C1519795 (UMLS CUI [1,2])
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)
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])
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])
C0022877 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (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])
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])
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])
C0032961 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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)
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])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])