ID

43527

Beskrivning

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

Länk

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

Nyckelord

2017-04-25 2017-04-25 -
2021-09-20 2021-09-20 -

Uppladdad den

20 september 2021

DOI

För en begäran logga in.

Licens

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

model
Detaljer

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

1 Formulär

StudyEvent: ODM
1. Screening Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Subject Information

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])

Demography

Item Group

Demography

C0011298 (UMLS CUI-1)

Date of birth

Item

Date of birth

date

C0421451 (UMLS CUI [1])

Sex

Item

Sex

text

C0079399 (UMLS CUI [1])

Sex

Code List

Sex

CL Item

Male (M)

CL Item

Female (F)

Ethnicity

Item

Ethnicity

text

C0015031 (UMLS CUI [1])

Ethnicity

Code List

Ethnicity

CL Item

Hispanic or Latino (1)

CL Item

Not Hispanic or Latino (2)

Geographic Ancestry

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)

Child-bearing Potential (Complete for Female Subjects Only)

Item Group

Child-bearing Potential (Complete for Female Subjects Only)

C1960468 (UMLS CUI-1)

Child-bearing Potential: Check one

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)

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

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])

Results

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)

Local Laboratory Result Data

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])

Medical Conditions

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])

Urine Drug Screen

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])

Amphetamines

Item

Amphetamines

text

C0002667 (UMLS CUI [1])

Amphetamines

Code List

Amphetamines

CL Item

positive (1)

CL Item

negative (2)

Barbiturates

Item

Barbiturates

text

C0004745 (UMLS CUI [1])

Barbiturates

Code List

Barbiturates

CL Item

positive (1)

CL Item

negative (2)

Cannabis

Item

Cannabis

text

C0936079 (UMLS CUI [1])

Cannabis

Code List

Cannabis

CL Item

positive (1)

CL Item

negative (2)

Cocaine

Item

Cocaine

text

C0009170 (UMLS CUI [1])

Cocaine

Code List

Cocaine

CL Item

positive (1)

CL Item

negative (2)

Morphine and derivatives

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)

Alcohol Test

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])

Results, check one

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)

Serology - HIV/Hepatitis Screen

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])

HIV antibody

Item

HIV antibody

text

C0019683 (UMLS CUI [1])

HIV antibody

Code List

HIV antibody

CL Item

Positive (1)

CL Item

Negative (2)

Hepatitis B surface antigen

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)

Hepatitis C antibody

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)

Physical examination

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])

Hair and skin

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])

Lymph nodes

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])

Eyes

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])

Ears, Nose and Throat

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])

Breasts

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])

Respiratory

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])

Cardiovascular

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])

Abdomen

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])

Urogenital

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])

Pelvic

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])

Rectal

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])

Musculoskeletal

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])

Neurological

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])

Mental Status

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])

History of tobacco use

Item Group

History of tobacco use

C0841002 (UMLS CUI-1)

What is the subject's history of tobacco use?

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])

Vital signs

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])

Planned Relative Time

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])

Subject position

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])

12-Lead ECG

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])

Planned Relative Time

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])

Result of the ECG

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)

12-Lead ECG Abnormalities

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])

12-Lead ECG Abnormalities: A. Rhythm

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])

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

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])

12-Lead ECG Abnormalities: C. Conduction

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])

12-Lead ECG Abnormalities: D. Myocardial Infarction

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])

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

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])

12-Lead ECG Abnormalities: Other Abnormalities

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])

Local laboratory result data (haematology)

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])

Has the subject fasted?

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])

Units for differential

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)

Local laboratory result data - (clinical chemistry)

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])

Has the subject fasted?

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])

Urinalysis

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])

Was sedimentary microscopy performed?

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])

Eligibility Question

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])

Inclusion Criteria

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])

Exclusion Criteria

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

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

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

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])

Investigator Comment Log

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])

Tillbaka till toppen

ID

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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

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