ID

25030

Beschreibung

Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease

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Versionen (2)
  1. 24.08.17 24.08.17 -
  2. 04.09.17 04.09.17 -
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GlaxoSmithKline

Hochgeladen am

24. August 2017

DOI

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physical examination determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

Englisch

physical examination determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Beschreibung

patient's initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Beschreibung

patient number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Date of Visit
Beschreibung

date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
SCREENING PHYSICAL EXAMINATION: body measures
Beschreibung

SCREENING PHYSICAL EXAMINATION: body measures

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0203910
WEIGHT
Beschreibung

body weight

Datentyp

float

Alias
UMLS CUI [1]
C0005910
WEIGHT
Beschreibung

body weight

Datentyp

integer

Alias
UMLS CUI [1]
C0005910
SCREENING PHYSICAL EXAMINATION: vital signs
Beschreibung

SCREENING PHYSICAL EXAMINATION: vital signs

Alias
UMLS CUI-1
C0031809
HEART RATE (supine)
Beschreibung

heart rate supine

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
bpm
HEART RATE (standing)
Beschreibung

heart rate standing

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C2029905
bpm
BLOOD PRESSURE (supine)
Beschreibung

systolic & diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
mmHg
BLOOD PRESSURE (standing)
Beschreibung

systolic & diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0580945
mmHg
BODY SYSTEMS
Beschreibung

BODY SYSTEMS

Alias
UMLS CUI-1
C0460002
GENERAL APPEARANCE & SKIN
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION?

Datentyp

integer

Alias
UMLS CUI [1]
C1148438
UMLS CUI [2]
C1123023
GENERAL APPEARANCE & SKIN
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION? If "Yes", describe the change.

Datentyp

text

Alias
UMLS CUI [1]
C1148438
UMLS CUI [2]
C1123023
HEAD, EYES, EARS, NOSE & THROAT
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION?

Datentyp

integer

Alias
UMLS CUI [1]
C0018670
UMLS CUI [2]
C0015392
UMLS CUI [3]
C0013443
UMLS CUI [4]
C0028429
UMLS CUI [5]
C0031354
HEAD, EYES, EARS, NOSE & THROAT
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION? If "Yes", describe the change.

Datentyp

text

Alias
UMLS CUI [1]
C0018670
UMLS CUI [2]
C0015392
UMLS CUI [3]
C0013443
UMLS CUI [4]
C0028429
UMLS CUI [5]
C0031354
CARDIOVASCULAR
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION?

Datentyp

integer

Alias
UMLS CUI [1]
C0007226
CARDIOVASCULAR
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION? If "Yes", describe the change.

Datentyp

text

Alias
UMLS CUI [1]
C0007226
RESPIRATORY
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION?

Datentyp

integer

Alias
UMLS CUI [1]
C0035237
RESPIRATORY
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION? If "Yes", describe the change.

Datentyp

text

Alias
UMLS CUI [1]
C0035237
ABDOMINAL& GASTROINTESTINAL
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION?

Datentyp

integer

Alias
UMLS CUI [1]
C0017189
ABDOMINAL& GASTROINTESTINAL
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION? If "Yes", describe the change.

Datentyp

text

Alias
UMLS CUI [1]
C0017189
MUSCULOSKELETAL
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION?

Datentyp

integer

Alias
UMLS CUI [1]
C0026860
MUSCULOSKELETAL
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION? If "Yes", describe the change.

Datentyp

text

Alias
UMLS CUI [1]
C0026860
NEUROLOGIC
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION?

Datentyp

integer

Alias
UMLS CUI [1]
C0027763
NEUROLOGIC
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION? If "Yes", describe the change.

Datentyp

text

Alias
UMLS CUI [1]
C0027763
GENITOURINARY
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION?

Datentyp

integer

Alias
UMLS CUI [1]
C0042066
GENITOURINARY
Beschreibung

HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION? If "Yes", describe the change.

Datentyp

text

Alias
UMLS CUI [1]
C0042066
OTHER
Beschreibung

Specify other aspects. HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION?

Datentyp

integer

Alias
UMLS CUI [1]
C0205394
OTHER
Beschreibung

Specify other aspects. HAVE THERE BEEN ANY CLINICALLY SIGNIFICANT CHANGES SINCE THE LAST EXAMINATION? If "Yes", describe the change.

Datentyp

text

Alias
UMLS CUI [1]
C0205394
EPWORTH SLEEP SCALE
Beschreibung

EPWORTH SLEEP SCALE

Alias
UMLS CUI-1
C3541276
EPWORTH SLEEP SCALE
Beschreibung

epworth sleepiness scale questionnaire

Datentyp

integer

Alias
UMLS CUI [1]
C3541276
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Ähnliche Modelle

physical examination determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
date of visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
SCREENING PHYSICAL EXAMINATION: body measures
C0031809 (UMLS CUI-1)
C0203910 (UMLS CUI-2)
body weight
Item
WEIGHT
float
C0005910 (UMLS CUI [1])
Item
WEIGHT
integer
C0005910 (UMLS CUI [1])
body weight
Code List
WEIGHT
CL Item
lb (1)
CL Item
kg (2)
Item Group
SCREENING PHYSICAL EXAMINATION: vital signs
C0031809 (UMLS CUI-1)
heart rate supine
Item
HEART RATE (supine)
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
heart rate standing
Item
HEART RATE (standing)
integer
C2029905 (UMLS CUI [1])
blood pressure supine
Item
BLOOD PRESSURE (supine)
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
blood pressure standing
Item
BLOOD PRESSURE (standing)
integer
C0580945 (UMLS CUI [1])
Item Group
BODY SYSTEMS
C0460002 (UMLS CUI-1)
Item
GENERAL APPEARANCE & SKIN
integer
C1148438 (UMLS CUI [1])
C1123023 (UMLS CUI [2])
general appearance and skin
Code List
GENERAL APPEARANCE & SKIN
CL Item
No (1)
CL Item
Improved (2)
CL Item
Worsened (3)
CL Item
Not done (4)
Item
GENERAL APPEARANCE & SKIN
text
C1148438 (UMLS CUI [1])
C1123023 (UMLS CUI [2])
general appearance and skin
Code List
GENERAL APPEARANCE & SKIN
Item
HEAD, EYES, EARS, NOSE & THROAT
integer
C0018670 (UMLS CUI [1])
C0015392 (UMLS CUI [2])
C0013443 (UMLS CUI [3])
C0028429 (UMLS CUI [4])
C0031354 (UMLS CUI [5])
general appearance and skin
Code List
HEAD, EYES, EARS, NOSE & THROAT
CL Item
No (1)
CL Item
Improved (2)
CL Item
Worsened (3)
CL Item
Not done (4)
head, eyes, ears, nose & throat
Item
HEAD, EYES, EARS, NOSE & THROAT
text
C0018670 (UMLS CUI [1])
C0015392 (UMLS CUI [2])
C0013443 (UMLS CUI [3])
C0028429 (UMLS CUI [4])
C0031354 (UMLS CUI [5])
Item
CARDIOVASCULAR
integer
C0007226 (UMLS CUI [1])
general appearance and skin
Code List
CARDIOVASCULAR
CL Item
No (1)
CL Item
Improved (2)
CL Item
Worsened (3)
CL Item
Not done (4)
Item
CARDIOVASCULAR
text
C0007226 (UMLS CUI [1])
general appearance and skin
Code List
CARDIOVASCULAR
Item
RESPIRATORY
integer
C0035237 (UMLS CUI [1])
general appearance and skin
Code List
RESPIRATORY
CL Item
No (1)
CL Item
Improved (2)
CL Item
Worsened (3)
CL Item
Not done (4)
respiratory system
Item
RESPIRATORY
text
C0035237 (UMLS CUI [1])
Item
ABDOMINAL& GASTROINTESTINAL
integer
C0017189 (UMLS CUI [1])
general appearance and skin
Code List
ABDOMINAL& GASTROINTESTINAL
CL Item
No (1)
CL Item
Improved (2)
CL Item
Worsened (3)
CL Item
Not done (4)
gastrointestinal tract
Item
ABDOMINAL& GASTROINTESTINAL
text
C0017189 (UMLS CUI [1])
Item
MUSCULOSKELETAL
integer
C0026860 (UMLS CUI [1])
general appearance and skin
Code List
MUSCULOSKELETAL
CL Item
No (1)
CL Item
Improved (2)
CL Item
Worsened (3)
CL Item
Not done (4)
musculoskeletal system
Item
MUSCULOSKELETAL
text
C0026860 (UMLS CUI [1])
Item
NEUROLOGIC
integer
C0027763 (UMLS CUI [1])
general appearance and skin
Code List
NEUROLOGIC
CL Item
No (1)
CL Item
Improved (2)
CL Item
Worsened (3)
CL Item
Not done (4)
Item
NEUROLOGIC
text
C0027763 (UMLS CUI [1])
general appearance and skin
Code List
NEUROLOGIC
Item
GENITOURINARY
integer
C0042066 (UMLS CUI [1])
general appearance and skin
Code List
GENITOURINARY
CL Item
No (1)
CL Item
Improved (2)
CL Item
Worsened (3)
CL Item
Not done (4)
Item
GENITOURINARY
text
C0042066 (UMLS CUI [1])
general appearance and skin
Code List
GENITOURINARY
Item
OTHER
integer
C0205394 (UMLS CUI [1])
general appearance and skin
Code List
OTHER
CL Item
No (1)
CL Item
Improved (2)
CL Item
Worsened (3)
CL Item
Not done (4)
other aspects
Item
OTHER
text
C0205394 (UMLS CUI [1])
Item Group
EPWORTH SLEEP SCALE
C3541276 (UMLS CUI-1)
epworth sleepiness scale questionnaire
Item
EPWORTH SLEEP SCALE
integer
C3541276 (UMLS CUI [1])
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