ID

25881

Beschreibung

Physical Examination, Laboratory, Parkinson's disease history - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL

Stichworte

Versionen (2)
  1. 24.09.17 24.09.17 -
  2. 24.09.17 24.09.17 -
Rechteinhaber

glaxoSmithKline

Hochgeladen am

24. September 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Physical Examination, Laboratory, Parkinson's disease history - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

Englisch

Physical Examination, Laboratory, Parkinson's disease history - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulare  
Physical examination
Beschreibung

Physical examination

Alias
UMLS CUI-1
C0031809
Height
Beschreibung

Height

Datentyp

float

Alias
UMLS CUI [1]
C0005890
Height Unit
Beschreibung

Height unit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C0439148
Weight
Beschreibung

Weight

Datentyp

float

Alias
UMLS CUI [1]
C0005910
Weight Unit
Beschreibung

Weight Unit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439148
Body Mass Index
Beschreibung

BMI

Datentyp

float

Maßeinheiten
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Physical examination
Beschreibung

Physical examination

Alias
UMLS CUI-1
C0031809
Body system
Beschreibung

Body system

Datentyp

integer

Alias
UMLS CUI [1,1]
C1268086
UMLS CUI [1,2]
C0449913
Body system abnormality
Beschreibung

Body system abnormality

Datentyp

integer

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C1704258
Describe abnormality
Beschreibung

Describe abnormality body system

Datentyp

text

Alias
UMLS CUI [1,1]
C0459424
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0678257
Hematology Laboratory evaluation
Beschreibung

Hematology Laboratory evaluation

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0200627
Serum Laboratory not done
Beschreibung

Serum Laboratory evaluation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0229671
Date of Sample
Beschreibung

Date of Sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Hematology Laboratory evaluation
Beschreibung

Hematology Laboratory evaluation

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0200627
Analyte
Beschreibung

Analyte

Datentyp

integer

Alias
UMLS CUI [1]
C0443354
Result
Beschreibung

laboratory Result

Datentyp

text

Alias
UMLS CUI [1]
C0587081
Unit
Beschreibung

Unit laboratory result

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clinical significant
Beschreibung

Clinical significant result

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0750502
Serum Laboratory evaluation
Beschreibung

Serum Laboratory evaluation

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0229671
Serum Laboratory not done
Beschreibung

Serum Laboratory evaluation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0229671
Date of Sample
Beschreibung

Date of Sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Serum laboratory evaluation
Beschreibung

Serum laboratory evaluation

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0229671
Analyte
Beschreibung

Analyte

Datentyp

integer

Alias
UMLS CUI [1]
C0443354
Result
Beschreibung

laboratory Result

Datentyp

text

Alias
UMLS CUI [1]
C0587081
Unit
Beschreibung

Unit laboratory result

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clinical significant
Beschreibung

Clinical significant result

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0750502
Hepatitis screening
Beschreibung

Hepatitis screening

Alias
UMLS CUI-1
C1445958
Date of sample
Beschreibung

Date of sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0019158
Hepatitis B surface antigen (HBsAG)
Beschreibung

Hepatitis B surface antigen

Datentyp

integer

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Beschreibung

Hepatitis C antibody

Datentyp

integer

Alias
UMLS CUI [1]
C0201487
HIV screening
Beschreibung

HIV screening

Alias
UMLS CUI-1
C0459958
Date of sample
Beschreibung

Date of sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0459958
Result of Human Immunodefiency Virus Antibody (ELISA)
Beschreibung

Human Immunodefiency Virus Antibody

Datentyp

integer

Alias
UMLS CUI [1,1]
C1321876
UMLS CUI [1,2]
C0201388
Urinalysis
Beschreibung

Urinalysis

Alias
UMLS CUI-1
C0042014
Date of examination
Beschreibung

Date of urinalysis

Datentyp

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0011008
Time
Beschreibung

Time of urinalysis

Datentyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
Dip stick analysis
Beschreibung

Dip stick analysis

Alias
UMLS CUI-1
C1160927
pH value
Beschreibung

pH urine

Datentyp

float

Alias
UMLS CUI [1]
C0042044
Protein
Beschreibung

If positive for blood or protein, please perform microscopic analysis

Datentyp

text

Alias
UMLS CUI [1]
C0430371
Glucose
Beschreibung

Urine glucose

Datentyp

text

Alias
UMLS CUI [1]
C0430376
Bilirubin
Beschreibung

Urine bilirubin

Datentyp

text

Alias
UMLS CUI [1]
C0430374
Blood
Beschreibung

If positive for blood or protein, please perform microscopic analysis

Datentyp

text

Alias
UMLS CUI [1]
C0430372
microscopic analysis
Beschreibung

If positive for blood or protein, please perform microscopic analysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0430397
Microscopic analysis
Beschreibung

Microscopic analysis

Alias
UMLS CUI-1
C0430397
Erythrocytes
Beschreibung

erythrocytes urine

Datentyp

integer

Maßeinheiten
  • cells per field
Alias
UMLS CUI [1]
C2188659
Leukocytes
Beschreibung

Leukocytes urine

Datentyp

integer

Maßeinheiten
  • cells per field
Alias
UMLS CUI [1]
C1254740
Bacteria
Beschreibung

Bacteria urine

Datentyp

integer

Alias
UMLS CUI [1,1]
C1262012
UMLS CUI [1,2]
C0004618
epithelia
Beschreibung

epithelia urine

Datentyp

integer

Alias
UMLS CUI [1,1]
C3828199
UMLS CUI [1,2]
C1273342
Salts
Beschreibung

salts urine

Datentyp

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0036140
Cast
Beschreibung

Urine cast

Datentyp

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0151990
Other
Beschreibung

Microscopic urinalysis other

Datentyp

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0205394
Overall urinalysis assessment
Beschreibung

Overall urinalysis assessment

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C1274040
Overall urinalysis assessment
Beschreibung

Overall urinalysis assessment

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1274040
If abnormal - clinically significant, describe
Beschreibung

Urinalysis abnormal specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0438142
UMLS CUI [1,2]
C1521902
Alcohol breath/ blood test
Beschreibung

Alcohol breath/ blood test

Alias
UMLS CUI-1
C0202304
Date of examination
Beschreibung

Date of alcohol test

Datentyp

date

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C0011008
Time
Beschreibung

Time of alcohol test

Datentyp

time

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C0040223
Result
Beschreibung

Result of alcohol test

Datentyp

integer

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C1274040
Subjects MUST refrain from consuming alcohol for 24h prior to the screening and follow - up visits and for 24 hours before and throughout Parts A and B. Has this subject consumed alcohol within the previous 24h?
Beschreibung

alcohol consumption

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0443288
Drug screening (urine)
Beschreibung

Drug screening (urine)

Alias
UMLS CUI-1
C0202274
Date of examination
Beschreibung

Date of drug screening

Datentyp

date

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0011008
Time
Beschreibung

Time of drug screening

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0202274
Cannabinoids
Beschreibung

Cannabinoids urine

Datentyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0006864
Morphine and morphine derivates
Beschreibung

Morphine and morphine derivates urine

Datentyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0279996
Amphetamine
Beschreibung

Amphetamine urine

Datentyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0002667
Barbiturates
Beschreibung

Barbiturates urine

Datentyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0004745
Benzodiazepines
Beschreibung

Benzodiazepines urine

Datentyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0005064
Cocaine
Beschreibung

Cocaine urine

Datentyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0009170
Tricyclic antidepressants
Beschreibung

Tricyclic antidepressants urine

Datentyp

integer

Alias
UMLS CUI [1]
C0003290
If positive, give further details.
Beschreibung

Urine drug screening positive specify

Datentyp

text

Alias
UMLS CUI [1,1]
C2711519
UMLS CUI [1,2]
C1521902
Smoking history
Beschreibung

Smoking history

Alias
UMLS CUI-1
C1519384
Smoker
Beschreibung

Smoker

Datentyp

text

Alias
UMLS CUI [1]
C0543414
Number of cigarettes per day.
Beschreibung

cigarettes per day

Datentyp

integer

Alias
UMLS CUI [1]
C3694146
Number of cigars per day.
Beschreibung

cigars per day

Datentyp

integer

Alias
UMLS CUI [1,1]
C0678446
UMLS CUI [1,2]
C0439505
Number of pipes per day.
Beschreibung

pipes per day

Datentyp

integer

Alias
UMLS CUI [1,1]
C0337665
UMLS CUI [1,2]
C0439505
Epworth sleep scale (ESS)
Beschreibung

Epworth sleep scale (ESS)

Alias
UMLS CUI-1
C3541276
Epworth sleep scale (ESS)
Beschreibung

EPWORTH SLEEP SCALE (ESS) This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Datentyp

text

Alias
UMLS CUI [1]
C3541276
Hoehn and Yahr stage
Beschreibung

Hoehn and Yahr stage

Alias
UMLS CUI-1
C3639483
Indicate the patient's baseline Hoehn & Yahr Stage by ticking the appropriate box below:
Beschreibung

Hoehn & Yahr Stage

Datentyp

text

Alias
UMLS CUI [1]
C3639483
Please confirm that the subject has refrained from strenuous activity (including competitive sports) for the 48 h prior to screening
Beschreibung

strenuous activity

Datentyp

integer

Alias
UMLS CUI [1]
C1514989
Prior medications for treatment of Parkinson's disease
Beschreibung

Prior medications for treatment of Parkinson's disease

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C0030567
Medication
Beschreibung

Use generic name

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0592502
Date started
Beschreibung

Medication date started

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Date stopped
Beschreibung

Medication date stopped

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Continuing
Beschreibung

Medication continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Dose and frequency
Beschreibung

e.g. 10mg tid

Datentyp

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C3476109
Route
Beschreibung

Route of drug administration

Datentyp

integer

Alias
UMLS CUI [1]
C0013153
Please, specify other route.
Beschreibung

Specify other route

Datentyp

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0013153
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Ähnliche Modelle

Physical Examination, Laboratory, Parkinson's disease history - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Item
Height Unit
integer
C0005890 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Height unit
Code List
Height Unit
CL Item
in (1)
CL Item
cm (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Weight Unit
integer
C0005910 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Weight Unit
Code List
Weight Unit
CL Item
lb (1)
CL Item
kg (2)
BMI
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Body system
integer
C1268086 (UMLS CUI [1,1])
C0449913 (UMLS CUI [1,2])
Body system
Code List
Body system
CL Item
General appearance and skin (1)
CL Item
Head, eyes, ears, nose, throat (2)
CL Item
Cardiovascular (3)
CL Item
Respiratory (4)
CL Item
Abdominal and gastrointestinal (5)
CL Item
Musculoskeletal (6)
CL Item
Neurological (7)
CL Item
Genitourinary (8)
CL Item
Hematopoietic and lymphatic (9)
CL Item
Endocrine and metabolic (10)
CL Item
other (11)
Item
Body system abnormality
integer
C0460002 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Body system abnormality
Code List
Body system abnormality
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done/ not applicable  (3)
Describe abnormality body system
Item
Describe abnormality
text
C0459424 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item Group
Hematology Laboratory evaluation
C0022885 (UMLS CUI-1)
C0200627 (UMLS CUI-2)
Serum Laboratory evaluation
Item
Serum Laboratory not done
boolean
C0022885 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
Date of Sample
Item
Date of Sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Hematology Laboratory evaluation
C0022885 (UMLS CUI-1)
C0200627 (UMLS CUI-2)
Item
Analyte
integer
C0443354 (UMLS CUI [1])
Analyte
Code List
Analyte
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Urea (3)
CL Item
Creatinine (4)
CL Item
Protein, total (5)
CL Item
Albumin (6)
CL Item
Globulin (7)
CL Item
Bilirubin, total (8)
CL Item
AST (SGOT) (9)
CL Item
ALT (SGPT) (10)
CL Item
Alkaline phosphatase (11)
CL Item
Calcium (12)
CL Item
Phosphate (13)
CL Item
Glucose (non-fasting) (14)
CL Item
GGT (15)
CL Item
Cholesterol (16)
CL Item
Triglycerides (17)
CL Item
Creatine phosphokinase (18)
laboratory Result
Item
Result
text
C0587081 (UMLS CUI [1])
Unit laboratory result
Item
Unit
text
C1519795 (UMLS CUI [1])
Clinical significant result
Item
Clinical significant
boolean
C0456984 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Item Group
Serum Laboratory evaluation
C0022885 (UMLS CUI-1)
C0229671 (UMLS CUI-2)
Serum Laboratory evaluation
Item
Serum Laboratory not done
boolean
C0022885 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
Date of Sample
Item
Date of Sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Serum laboratory evaluation
C0022885 (UMLS CUI-1)
C0229671 (UMLS CUI-2)
Item
Analyte
integer
C0443354 (UMLS CUI [1])
Analyte
Code List
Analyte
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Urea (3)
CL Item
Creatinine (4)
CL Item
Protein, total (5)
CL Item
Albumin (6)
CL Item
Globulin (7)
CL Item
Bilirubin, total (8)
CL Item
AST (SGOT) (9)
CL Item
ALT (SGPT) (10)
CL Item
Alkaline phosphatase (11)
CL Item
Calcium (12)
CL Item
Phosphate (13)
CL Item
Glucose (non-fasting) (14)
CL Item
GGT (15)
CL Item
Cholesterol (16)
CL Item
Triglycerides (17)
CL Item
Creatine phosphokinase (18)
laboratory Result
Item
Result
text
C0587081 (UMLS CUI [1])
Unit laboratory result
Item
Unit
text
C1519795 (UMLS CUI [1])
Clinical significant result
Item
Clinical significant
boolean
C0456984 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Item Group
Hepatitis screening
C1445958 (UMLS CUI-1)
Date of sample
Item
Date of sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0019158 (UMLS CUI [1,3])
Item
Hepatitis B surface antigen (HBsAG)
integer
C0019168 (UMLS CUI [1])
Hepatitis B surface antigen
Code List
Hepatitis B surface antigen (HBsAG)
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis C antibody
integer
C0201487 (UMLS CUI [1])
Hepatitis C antibody
Code List
Hepatitis C antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
HIV screening
C0459958 (UMLS CUI-1)
Date of sample
Item
Date of sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0459958 (UMLS CUI [1,3])
Item
Result of Human Immunodefiency Virus Antibody (ELISA)
integer
C1321876 (UMLS CUI [1,1])
C0201388 (UMLS CUI [1,2])
Human Immunodefiency Virus Antibody
Code List
Result of Human Immunodefiency Virus Antibody (ELISA)
CL Item
positive (1)
CL Item
negative (2)
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Date of urinalysis
Item
Date of examination
date
C0042014 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of urinalysis
Item
Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Dip stick analysis
C1160927 (UMLS CUI-1)
pH urine
Item
pH value
float
C0042044 (UMLS CUI [1])
Item
Protein
text
C0430371 (UMLS CUI [1])
Urine Protein
Code List
Protein
CL Item
neg  (neg)
CL Item
pos (pos)
Item
Glucose
text
C0430376 (UMLS CUI [1])
Urine glucose
Code List
Glucose
CL Item
neg (neg)
CL Item
pos (pos)
Item
Bilirubin
text
C0430374 (UMLS CUI [1])
Urine bilirubin
Code List
Bilirubin
CL Item
neg (neg)
CL Item
pos (pos)
Item
Blood
text
C0430372 (UMLS CUI [1])
Urine blood
Code List
Blood
CL Item
neg (neg)
CL Item
pos (pos)
urine microscopic analysis
Item
microscopic analysis
boolean
C0430397 (UMLS CUI [1])
Item Group
Microscopic analysis
C0430397 (UMLS CUI-1)
Item
Erythrocytes
integer
C2188659 (UMLS CUI [1])
erythrocytes urine
Code List
Erythrocytes
CL Item
0 - 3 (1)
CL Item
4 - 6 (2)
CL Item
7-10 (3)
CL Item
11-20 (4)
CL Item
>20 (5)
Item
Leukocytes
integer
C1254740 (UMLS CUI [1])
Leukocytes urine
Code List
Leukocytes
CL Item
0 - 3 (1)
CL Item
4 - 6 (2)
CL Item
7-10 (3)
CL Item
11-20 (4)
CL Item
>20 (5)
Item
Bacteria
integer
C1262012 (UMLS CUI [1,1])
C0004618 (UMLS CUI [1,2])
Bacteria urine
Code List
Bacteria
CL Item
none (1)
CL Item
few (2)
CL Item
moderate (3)
CL Item
abundant (4)
Item
epithelia
integer
C3828199 (UMLS CUI [1,1])
C1273342 (UMLS CUI [1,2])
epithelia urine
Code List
epithelia
CL Item
none (1)
CL Item
squamous (2)
CL Item
round (3)
CL Item
other (4)
salts urine
Item
Salts
text
C0430397 (UMLS CUI [1,1])
C0036140 (UMLS CUI [1,2])
Urine cast
Item
Cast
text
C0430397 (UMLS CUI [1,1])
C0151990 (UMLS CUI [1,2])
Microscopic urinalysis other
Item
Other
text
C0430397 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Overall urinalysis assessment
C0042014 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Item
Overall urinalysis assessment
integer
C0042014 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Overall urinalysis assessment
Code List
Overall urinalysis assessment
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Urinalysis abnormal specify
Item
If abnormal - clinically significant, describe
text
C0438142 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Alcohol breath/ blood test
C0202304 (UMLS CUI-1)
Date of alcohol test
Item
Date of examination
date
C0202304 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of alcohol test
Item
Time
time
C0202304 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Result
integer
C0202304 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of alcohol test
Code List
Result
CL Item
negative (1)
CL Item
positive (2)
alcohol consumption
Item
Subjects MUST refrain from consuming alcohol for 24h prior to the screening and follow - up visits and for 24 hours before and throughout Parts A and B. Has this subject consumed alcohol within the previous 24h?
boolean
C0001948 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Item Group
Drug screening (urine)
C0202274 (UMLS CUI-1)
Date of drug screening
Item
Date of examination
date
C0202274 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of drug screening
Item
Time
time
C0040223 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
Item
Cannabinoids
integer
C0202274 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Cannabinoids urine
Code List
Cannabinoids
CL Item
negative (1)
CL Item
positive (2)
Item
Morphine and morphine derivates
integer
C0202274 (UMLS CUI [1,1])
C0279996 (UMLS CUI [1,2])
Morphine and morphine derivates urine
Code List
Morphine and morphine derivates
CL Item
negative (1)
CL Item
positive (2)
Item
Amphetamine
integer
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Amphetamine urine
Code List
Amphetamine
CL Item
negative (1)
CL Item
positive (2)
Item
Barbiturates
integer
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Barbiturates urine
Code List
Barbiturates
CL Item
negative (1)
CL Item
positive (2)
Item
Benzodiazepines
integer
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Benzodiazepines urine
Code List
Benzodiazepines
CL Item
negative (1)
CL Item
positive (2)
Item
Cocaine
integer
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Cocaine urine
Code List
Cocaine
CL Item
negative (1)
CL Item
positive (2)
Item
Tricyclic antidepressants
integer
C0003290 (UMLS CUI [1])
Tricyclic antidepressants urine
Code List
Tricyclic antidepressants
CL Item
negative (1)
CL Item
positive (2)
Urine drug screening positive specify
Item
If positive, give further details.
text
C2711519 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Smoking history
C1519384 (UMLS CUI-1)
Item
Smoker
text
C0543414 (UMLS CUI [1])
Smoker
Code List
Smoker
CL Item
yes (1)
CL Item
no (2)
cigarettes per day
Item
Number of cigarettes per day.
integer
C3694146 (UMLS CUI [1])
cigars per day
Item
Number of cigars per day.
integer
C0678446 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
pipes per day
Item
Number of pipes per day.
integer
C0337665 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
Item Group
Epworth sleep scale (ESS)
C3541276 (UMLS CUI-1)
Epworth sleep scale (ESS)
Item
Epworth sleep scale (ESS)
text
C3541276 (UMLS CUI [1])
Item Group
Hoehn and Yahr stage
C3639483 (UMLS CUI-1)
Item
Indicate the patient's baseline Hoehn & Yahr Stage by ticking the appropriate box below:
text
C3639483 (UMLS CUI [1])
Hoehn & Yahr Stage
Code List
Indicate the patient's baseline Hoehn & Yahr Stage by ticking the appropriate box below:
CL Item
No signs of disease (Stage 0)
CL Item
Unilateral disease (Stage 1)
CL Item
Unilateral disease plus axial involvement (Stage 1.5)
CL Item
Mild bilateral disease, without impairment of balance (Stage 2)
CL Item
Mild bilateral disease, with recovery on pull test (Stage 2.5)
CL Item
Mild to moderate bilateral disease: some postural instability; physically independent (Stage 3)
CL Item
Severe disability: still able to walk or stand unassisted  (Stage 4)
CL Item
Wheelchair bound or bedridden unless aided (Stage 5)
Item
Please confirm that the subject has refrained from strenuous activity (including competitive sports) for the 48 h prior to screening
integer
C1514989 (UMLS CUI [1])
strenuous activity
Code List
Please confirm that the subject has refrained from strenuous activity (including competitive sports) for the 48 h prior to screening
CL Item
yes (1)
CL Item
no (2)
Item Group
Prior medications for treatment of Parkinson's disease
C2826257 (UMLS CUI-1)
C0030567 (UMLS CUI-2)
Generic name medication
Item
Medication
text
C0013227 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
Medication date started
Item
Date started
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication date stopped
Item
Date stopped
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication continuous
Item
Continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Dose and frequency of medication
Item
Dose and frequency
text
C3174092 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])
Item
Route
integer
C0013153 (UMLS CUI [1])
Route of drug administration
Code List
Route
CL Item
IV  (1)
CL Item
PR (2)
CL Item
IM  (3)
CL Item
Sublingual  (4)
CL Item
PO  (5)
CL Item
Inhaled  (6)
CL Item
SC  (7)
CL Item
Topical (8)
CL Item
other (9)
Specify other route
Item
Please, specify other route.
text
C1521902 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
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