ID

25447

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

Stichworte

Versionen (2)
  1. 16.08.17 16.08.17 -
  2. 04.09.17 04.09.17 -
Hochgeladen am

4. September 2017

DOI

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visit 1 medical history starting dose of ropinirole Parkinson's Disease 101468/166

Englisch

visit 1 medical history starting dose of ropinirole 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
DEMOGRAPHICS
Beschreibung

DEMOGRAPHICS

Alias
UMLS CUI-1
C0011298
Date of Birth
Beschreibung

date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

sex

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

If "other", specify.

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
BODY SYSTEMS
Beschreibung

BODY SYSTEMS

Alias
UMLS CUI-1
C0460002
GENERAL APPEARANCE & SKIN
Beschreibung

general appearance and skin

Datentyp

integer

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

If "abnormal" above, describe abnormality.

Datentyp

text

Alias
UMLS CUI [1,1]
C1148438
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C1123023
UMLS CUI [2,2]
C1704258
HEAD, EYES, EARS, NOSE & THROAT
Beschreibung

head, eyes, ears, nose & throat

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 ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0018670
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C0015392
UMLS CUI [2,2]
C1704258
UMLS CUI [3,1]
C0013443
UMLS CUI [3,2]
C1704258
UMLS CUI [4,1]
C0028429
UMLS CUI [4,2]
C1704258
UMLS CUI [5,1]
C0031354
UMLS CUI [5,2]
C1704258
CARDIOVASCULAR
Beschreibung

cardiovascular system

Datentyp

integer

Alias
UMLS CUI [1]
C0007226
CARDIOVASCULAR ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0243050
RESPIRATORY
Beschreibung

respiratory system

Datentyp

integer

Alias
UMLS CUI [1]
C0035237
RESPIRATORY ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0035204
ABDOMINAL& GASTROINTESTINAL
Beschreibung

gastrointestinal tract

Datentyp

integer

Alias
UMLS CUI [1]
C0017189
ABDOMINAL& GASTROINTESTINAL ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0017178
MUSCULOSKELETAL
Beschreibung

musculoskeletal system

Datentyp

integer

Alias
UMLS CUI [1]
C0026860
MUSCULOSKELETAL ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0026857
NEUROLOGIC
Beschreibung

neurologic system

Datentyp

integer

Alias
UMLS CUI [1]
C0027763
NEUROLOGIC ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0027765
GENITOURINARY
Beschreibung

genitourinary system

Datentyp

integer

Alias
UMLS CUI [1]
C0042066
GENITOURINARY ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0080276
HEMATOPOIETIC& LYMPHATIC
Beschreibung

hematopoetic system and lymphatic system

Datentyp

integer

Alias
UMLS CUI [1]
C0018957
UMLS CUI [2]
C0024235
HEMATOPOIETIC& LYMPHATIC ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0024228
ENDOCRINE & METABOLIC
Beschreibung

endocrine system

Datentyp

integer

Alias
UMLS CUI [1]
C0014136
ENDOCRINE & METABOLIC ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality.

Datentyp

text

Alias
UMLS CUI [1]
C0014130
OTHER
Beschreibung

Specify other aspects.

Datentyp

integer

Alias
UMLS CUI [1]
C0205394
OTHER ASPECTS ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1704258
Surgical Procedures
Beschreibung

Surgical Procedures

Alias
UMLS CUI-1
C0543467
Surgical Procedures related to Parkinson's Disease
Beschreibung

If "Yes", specify by fulfilling the items below.

Datentyp

integer

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

If "Yes" above. Fulfill this and the following item for each surgical procedure separately.

Datentyp

date

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0011008
Type of Surgical Procedure
Beschreibung

If "Yes" above. Fulfill this and the item above for each surgical procedure separately.

Datentyp

text

Alias
UMLS CUI [1]
C0543467
Allergies
Beschreibung

Allergies

Alias
UMLS CUI-1
C0020517
Allergies
Beschreibung

If "yes", specify below.

Datentyp

integer

Alias
UMLS CUI [1]
C0020517
Allergen
Beschreibung

If "yes" above, fulfill this and the following item for each allergie separately.

Datentyp

text

Alias
UMLS CUI [1]
C0002092
Reaction
Beschreibung

reaction to allergen

Datentyp

text

Alias
UMLS CUI [1,1]
C0205332
UMLS CUI [1,2]
C0002092
DURATION OF PARKINSON'S DISEASE
Beschreibung

DURATION OF PARKINSON'S DISEASE

Alias
UMLS CUI-1
C0449238
UMLS CUI-2
C0030567
Date of Onset of Symptoms of Parkinson's disease
Beschreibung

date of onset of symptoms of Parkinson's disease

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1320528
UMLS CUI [1,3]
C0030567
HOEHN & YAHR STAGE
Beschreibung

HOEHN & YAHR STAGE

Alias
UMLS CUI-1
C0451215
HOEHN & YAHR STAGE
Beschreibung

Hoehn-Yahr Stage

Datentyp

integer

Alias
UMLS CUI [1]
C0451215
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

visit 1 medical history starting dose of ropinirole 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
DEMOGRAPHICS
C0011298 (UMLS CUI-1)
date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
race
Code List
Race
CL Item
Caucasian (1)
CL Item
Black (2)
CL Item
Asian (3)
CL Item
Hispanic (4)
CL Item
Other, specify (5)
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
normal (1)
CL Item
abnormal (2)
general appearance and skin abnormalities
Item
GENERAL APPEARANCE & SKIN ABNORMALITY
text
C1148438 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1123023 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
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])
head, eyes, ears, nose & throat
Code List
HEAD, EYES, EARS, NOSE & THROAT
CL Item
normal (1)
CL Item
abnormal (2)
head, eyes, ears, nose & throat abnormalities
Item
HEAD, EYES, EARS, NOSE & THROAT ABNORMALITY
text
C0018670 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0015392 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0013443 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C0028429 (UMLS CUI [4,1])
C1704258 (UMLS CUI [4,2])
C0031354 (UMLS CUI [5,1])
C1704258 (UMLS CUI [5,2])
Item
CARDIOVASCULAR
integer
C0007226 (UMLS CUI [1])
cardiovascular system
Code List
CARDIOVASCULAR
CL Item
normal (1)
CL Item
abnormal (2)
cardiovascular abnormalities
Item
CARDIOVASCULAR ABNORMALITY
text
C0243050 (UMLS CUI [1])
Item
RESPIRATORY
integer
C0035237 (UMLS CUI [1])
respiratory system
Code List
RESPIRATORY
CL Item
normal (1)
CL Item
abnormal (2)
respiratory disorders
Item
RESPIRATORY ABNORMALITY
text
C0035204 (UMLS CUI [1])
Item
ABDOMINAL& GASTROINTESTINAL
integer
C0017189 (UMLS CUI [1])
gastrointestinal tract
Code List
ABDOMINAL& GASTROINTESTINAL
CL Item
normal (1)
CL Item
abnormal (2)
gastrointestinal disorders
Item
ABDOMINAL& GASTROINTESTINAL ABNORMALITY
text
C0017178 (UMLS CUI [1])
Item
MUSCULOSKELETAL
integer
C0026860 (UMLS CUI [1])
musculoskeletal system
Code List
MUSCULOSKELETAL
CL Item
normal (1)
CL Item
abnormal (2)
musculoskeletal disorders
Item
MUSCULOSKELETAL ABNORMALITY
text
C0026857 (UMLS CUI [1])
Item
NEUROLOGIC
integer
C0027763 (UMLS CUI [1])
neurologic system
Code List
NEUROLOGIC
CL Item
normal (1)
CL Item
abnormal (2)
neurological disorders
Item
NEUROLOGIC ABNORMALITY
text
C0027765 (UMLS CUI [1])
Item
GENITOURINARY
integer
C0042066 (UMLS CUI [1])
genitourinary system
Code List
GENITOURINARY
CL Item
normal (1)
CL Item
abnormal (2)
genitourinary disorder
Item
GENITOURINARY ABNORMALITY
text
C0080276 (UMLS CUI [1])
Item
HEMATOPOIETIC& LYMPHATIC
integer
C0018957 (UMLS CUI [1])
C0024235 (UMLS CUI [2])
hematopoetic system and lymphatic system
Code List
HEMATOPOIETIC& LYMPHATIC
CL Item
normal (1)
CL Item
abnormal (2)
hematopoetic disorders and lymphatic disorders
Item
HEMATOPOIETIC& LYMPHATIC ABNORMALITY
text
C0024228 (UMLS CUI [1])
Item
ENDOCRINE & METABOLIC
integer
C0014136 (UMLS CUI [1])
endocrine system
Code List
ENDOCRINE & METABOLIC
CL Item
normal (1)
CL Item
abnormal (2)
endocrine system disorders
Item
ENDOCRINE & METABOLIC ABNORMALITY
text
C0014130 (UMLS CUI [1])
Item
OTHER
integer
C0205394 (UMLS CUI [1])
other aspects
Code List
OTHER
CL Item
normal (1)
CL Item
abnormal (2)
Item
OTHER ASPECTS ABNORMALITY
text
C0205394 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
other aspects
Code List
OTHER ASPECTS ABNORMALITY
Item Group
Surgical Procedures
C0543467 (UMLS CUI-1)
Item
Surgical Procedures related to Parkinson's Disease
integer
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
surgical procedures related to Parkinson's Disease
Code List
Surgical Procedures related to Parkinson's Disease
CL Item
Yes (1)
CL Item
No (2)
date of surgical procedure
Item
Date of Surgical Procedure
date
C0543467 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
type of surgical procedure
Item
Type of Surgical Procedure
text
C0543467 (UMLS CUI [1])
Item Group
Allergies
C0020517 (UMLS CUI-1)
Item
Allergies
integer
C0020517 (UMLS CUI [1])
allergies
Code List
Allergies
CL Item
Yes (1)
CL Item
No (2)
allergen
Item
Allergen
text
C0002092 (UMLS CUI [1])
reaction to allergen
Item
Reaction
text
C0205332 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
Item Group
DURATION OF PARKINSON'S DISEASE
C0449238 (UMLS CUI-1)
C0030567 (UMLS CUI-2)
date of onset of symptoms of Parkinson's disease
Item
Date of Onset of Symptoms of Parkinson's disease
date
C0011008 (UMLS CUI [1,1])
C1320528 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Item Group
HOEHN & YAHR STAGE
C0451215 (UMLS CUI-1)
Hoehn-Yahr Stage
Item
HOEHN & YAHR STAGE
integer
C0451215 (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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