ID

25786

Beschreibung

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

Stichworte

Versionen (1)
  1. 19.09.17 19.09.17 -
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GlaxoSmithKline

Hochgeladen am

19. September 2017

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screening physical examination Ropinirole CR Ropinirole IR Monotherapy 101468/168

Englisch

screening physical examination Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
VITAL SIGNS
Beschreibung

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Height
Beschreibung

height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Semi-Supine Blood Pressure Systolic
Beschreibung

semi-supine blood pressure systolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Semi-Supine Blood Pressure Diastolic
Beschreibung

semi-supine blood pressure diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Semi-Supine Heart Rate
Beschreibung

semi-supine heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
beats/min
Standing Blood Pressure Systolic
Beschreibung

standing blood pressure systolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Standing Blood Pressure Diastolic
Beschreibung

standing blood pressure diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
Standing Heart Rate
Beschreibung

standing heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C2029905
beats/min
NEUROLOGICAL EXAMINATION
Beschreibung

NEUROLOGICAL EXAMINATION

Alias
UMLS CUI-1
C0027853
Neurological System
Beschreibung

neurological system

Datentyp

text

Alias
UMLS CUI [1]
C0027853
Status
Beschreibung

status

Datentyp

integer

Alias
UMLS CUI [1]
C0449438
Comments
Beschreibung

comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Was the neurological examination consistent with the diagnosis of Parkinson’s disease?
Beschreibung

If NO, the subject is not eligible to participate in the study

Datentyp

text

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0750484
MODIFIED HOEHN AND YAHR PARKINSON’S DISEASE STAGING
Beschreibung

MODIFIED HOEHN AND YAHR PARKINSON’S DISEASE STAGING

Alias
UMLS CUI-1
C0451215
modified Hoehn and Yahr Parkinson's Disease staging
Beschreibung

hoehn and yahr staging

Datentyp

text

Alias
UMLS CUI [1]
C0451215
SURGICAL PROCEDURES
Beschreibung

SURGICAL PROCEDURES

Alias
UMLS CUI-1
C0543467
Has the subject had any surgical procedures related to Parkinson’s disease?
Beschreibung

If yes, specify below and fulfill the following items for each procedure separately.

Datentyp

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0030567
Date of procedure
Beschreibung

date of procedure

Datentyp

date

Alias
UMLS CUI [1]
C2584899
Details
Beschreibung

details

Datentyp

text

Alias
UMLS CUI [1]
C1522508
12-LEAD ECG
Beschreibung

12-LEAD ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Beschreibung

date of ECG

Datentyp

date

Alias
UMLS CUI [1]
C2826640
Result of ECG
Beschreibung

Note: If the ECG is Abnormal and clinically significant, the subject is not eligible for the study

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
CENTRAL LABORATORY
Beschreibung

CENTRAL LABORATORY

Alias
UMLS CUI-1
C1880016
Date sample taken
Beschreibung

date sample taken

Datentyp

date

Alias
UMLS CUI [1]
C1302413
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Ähnliche Modelle

screening physical examination Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
height
Item
Height
integer
C0005890 (UMLS CUI [1])
weight
Item
Weight
float
C0005910 (UMLS CUI [1])
semi-supine blood pressure systolic
Item
Semi-Supine Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
semi-supine blood pressure diastolic
Item
Semi-Supine Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
semi-supine heart rate
Item
Semi-Supine Heart Rate
integer
C0522019 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
standing blood pressure systolic
Item
Standing Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
standing blood pressure diastolic
Item
Standing Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
standing heart rate
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
Item Group
NEUROLOGICAL EXAMINATION
C0027853 (UMLS CUI-1)
Item
Neurological System
text
C0027853 (UMLS CUI [1])
neurological system
Code List
Neurological System
CL Item
Mental Status (Mental Status)
CL Item
Gait (Gait)
CL Item
Balance (Balance)
CL Item
Coordination (Coordination)
CL Item
Cranial nerves (Cranial nerves)
CL Item
Motor (Motor)
CL Item
Reflexes (Reflexes)
CL Item
Sensory (Sensory)
Item
Status
integer
C0449438 (UMLS CUI [1])
status
Code List
Status
CL Item
Normal (0)
CL Item
Abnormal (1)
comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item
Was the neurological examination consistent with the diagnosis of Parkinson’s disease?
text
C0030567 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
parkinson's disease confirmed
Code List
Was the neurological examination consistent with the diagnosis of Parkinson’s disease?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
MODIFIED HOEHN AND YAHR PARKINSON’S DISEASE STAGING
C0451215 (UMLS CUI-1)
hoehn and yahr staging
Item
modified Hoehn and Yahr Parkinson's Disease staging
text
C0451215 (UMLS CUI [1])
Item Group
SURGICAL PROCEDURES
C0543467 (UMLS CUI-1)
Item
Has the subject had any surgical procedures related to Parkinson’s disease?
text
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
surgical procedures due to Parkinson's disease
Code List
Has the subject had any surgical procedures related to Parkinson’s disease?
CL Item
Yes (Y)
CL Item
No (N)
date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1])
details
Item
Details
text
C1522508 (UMLS CUI [1])
Item Group
12-LEAD ECG
C0430456 (UMLS CUI-1)
date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Result of ECG
integer
C0438154 (UMLS CUI [1])
ECG Finding
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant -> Complete the current medical conditions page. (3)
Item Group
CENTRAL LABORATORY
C1880016 (UMLS CUI-1)
date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
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