ID

25728

Beschreibung

Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Screening form.

Stichworte

Versionen (1)
  1. 14.09.17 14.09.17 -
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GlaxoSmithKline

Hochgeladen am

14. September 2017

DOI

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GSK Ropinirole in Patients Suffering from Parkinsons Disease Screening 101468/169 NCT00381472

Englisch

GSK Ropinirole in Patients Suffering from Parkinsons Disease Screening 101468/169 NCT00381472

1 Formulare  
General
Beschreibung

General

Alias
UMLS CUI-1
C0205246
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
UNIFIED PARKINSON’S DISEASE RATING SCALE
Beschreibung

UNIFIED PARKINSON’S DISEASE RATING SCALE

Alias
UMLS CUI-1
C0030567
UMLS CUI-2
C0681889
UNIFIED PARKINSON’S DISEASE RATING SCALE
Beschreibung

UNIFIED PARKINSON’S DISEASE RATING SCALE

Datentyp

text

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0681889
DEMOGRAPHY
Beschreibung

DEMOGRAPHY

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
PAST MEDICAL CONDITIONS
Beschreibung

PAST MEDICAL CONDITIONS

Alias
UMLS CUI-1
C0262926
Blood and lymphatic system disorders
Beschreibung

Blood and lymphatic system disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0851353
Blood and lymphatic system disorders
Beschreibung

Blood and lymphatic system disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0851353
Cardiac disorders
Beschreibung

Cardiac disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0018799
Cardiac disorders
Beschreibung

Cardiac disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0018799
Ear and labyrinth disorder
Beschreibung

Ear and labyrinth disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0851354
Ear and labyrinth disorder
Beschreibung

Ear and labyrinth disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0851354
Endocrine disorders
Beschreibung

Endocrine disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0014130
Endocrine disorders
Beschreibung

Endocrine disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0014130
Eye disorders
Beschreibung

Eye disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0015397
Eye disorders
Beschreibung

Eye disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0015397
Gastrointestinal disorders
Beschreibung

Gastrointestinal disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0017178
Gastrointestinal disorders
Beschreibung

Gastrointestinal disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0017178
Hepatobiliary disorders
Beschreibung

Hepatobiliary disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0267792
Hepatobiliary disorders
Beschreibung

Hepatobiliary disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0267792
Immune system disorders
Beschreibung

Immune system disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1334156
Immune system disorders
Beschreibung

Immune system disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1334156
Metabolism and nutrition disorders
Beschreibung

Metabolism and nutrition disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0851358
Metabolism and nutrition disorders
Beschreibung

Metabolism and nutrition disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0851358
Musculoskeletal and connective tissue disorders
Beschreibung

Musculoskeletal and connective tissue disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0263660
Musculoskeletal and connective tissue disorders
Beschreibung

Musculoskeletal and connective tissue disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0263660
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
Beschreibung

Neoplasms benign, malignant and unspecified (inc. cysts and polyps)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1882062
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
Beschreibung

Neoplasms benign, malignant and unspecified (inc. cysts and polyps)

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1882062
Nervous system disorders
Beschreibung

Nervous system disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0810273
Nervous system disorders
Beschreibung

Nervous system disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0810273
Psychiatric disorders
Beschreibung

Psychiatric disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004936
Psychiatric disorders
Beschreibung

Psychiatric disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004936
Renal and urinary disorders
Beschreibung

Renal and urinary disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0042075
Renal and urinary disorders
Beschreibung

Renal and urinary disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0042075
Reproductive system and breast disorders
Beschreibung

Reproductive system and breast disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0851366
Reproductive system and breast disorders
Beschreibung

Reproductive system and breast disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0851366
Respiratory, thoracic and mediastinal disorders
Beschreibung

Respiratory, thoracic and mediastinal disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0851355
Respiratory, thoracic and mediastinal disorders
Beschreibung

Respiratory, thoracic and mediastinal disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0851355
Skin and subcutaneous tissue disorders
Beschreibung

Skin and subcutaneous tissue disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0037274
Skin and subcutaneous tissue disorders
Beschreibung

Skin and subcutaneous tissue disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0037274
Vascular disorders
Beschreibung

Vascular disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0042373
Vascular disorders
Beschreibung

Vascular disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0042373
CURRENT MEDICAL CONDITIONS
Beschreibung

CURRENT MEDICAL CONDITIONS

Alias
UMLS CUI-1
C3899485
Blood and lymphatic system disorders
Beschreibung

Blood and lymphatic system disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0851353
Blood and lymphatic system disorders
Beschreibung

Blood and lymphatic system disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0851353
Cardiac disorders
Beschreibung

Cardiac disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0018799
Cardiac disorders
Beschreibung

Cardiac disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0018799
Ear and labyrinth disorder
Beschreibung

Ear and labyrinth disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0851354
Ear and labyrinth disorder
Beschreibung

Ear and labyrinth disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0851354
Endocrine disorders
Beschreibung

Endocrine disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0014130
Endocrine disorders
Beschreibung

Endocrine disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0014130
Eye disorders
Beschreibung

Eye disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0015397
Eye disorders
Beschreibung

Eye disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0015397
Gastrointestinal disorders
Beschreibung

Gastrointestinal disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0017178
Gastrointestinal disorders
Beschreibung

Gastrointestinal disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0017178
Hepatobiliary disorders
Beschreibung

Hepatobiliary disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0267792
Hepatobiliary disorders
Beschreibung

Hepatobiliary disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0267792
Immune system disorders
Beschreibung

Immune system disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C1334156
Immune system disorders
Beschreibung

Immune system disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C1334156
Metabolism and nutrition disorders
Beschreibung

Metabolism and nutrition disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0851358
Metabolism and nutrition disorders
Beschreibung

Metabolism and nutrition disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0851358
Musculoskeletal and connective tissue disorders
Beschreibung

Musculoskeletal and connective tissue disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0263660
Musculoskeletal and connective tissue disorders
Beschreibung

Musculoskeletal and connective tissue disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0263660
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
Beschreibung

Neoplasms benign, malignant and unspecified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C1882062
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
Beschreibung

Neoplasms benign, malignant and unspecified

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C1882062
Nervous system disorders
Beschreibung

Nervous system disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0810273
Nervous system disorders
Beschreibung

Nervous system disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0810273
Psychiatric disorders
Beschreibung

Psychiatric disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0004936
Psychiatric disorders
Beschreibung

Psychiatric disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0004936
Renal and urinary disorders
Beschreibung

Renal and urinary disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0042075
Renal and urinary disorders
Beschreibung

Renal and urinary disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0042075
Reproductive system and breast disorders
Beschreibung

Reproductive system and breast disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0851366
Reproductive system and breast disorders
Beschreibung

Reproductive system and breast disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0851366
Respiratory, thoracic and mediastinal disorders
Beschreibung

Respiratory, thoracic and mediastinal disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0851355
Respiratory, thoracic and mediastinal disorders
Beschreibung

Respiratory, thoracic and mediastinal disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0851355
Skin and subcutaneous tissue disorders
Beschreibung

Skin and subcutaneous tissue disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0037274
Skin and subcutaneous tissue disorders
Beschreibung

Skin and subcutaneous tissue disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0037274
Vascular disorders
Beschreibung

Vascular disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0042373
Vascular disorders
Beschreibung

Vascular disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0042373
PRIOR PARKINSON’S MEDICATION
Beschreibung

PRIOR PARKINSON’S MEDICATION

Alias
UMLS CUI-1
C0030567
UMLS CUI-2
C0013227
Has the subject taken any prior Parkinson’s medication within 30 days prior to the study (excluding L-Dopa)? If Yes, record each medication on a separate line using Trade Names where possible.
Beschreibung

Parkinson’s medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
Drug Name
Beschreibung

Drug Name

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0030567
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0030567
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C1519795
UMLS CUI [1,3]
C0013227
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0013227
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0013227
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0808070
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0806020
Ongoing Medication?
Beschreibung

Ongoing Medication?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C2826666
L-DOPA MEDICATION HISTORY
Beschreibung

L-DOPA MEDICATION HISTORY

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0023570
When did the subject first start taking L-Dopa?
Beschreibung

Record any L-Dopa medication taken within 30 days prior to the study in the L-Dopa Medication section.

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0023570
PRIOR OR CONCOMITANT MEDICATIONS
Beschreibung

PRIOR OR CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2826257
Were any concomitant medications taken by the subject within 30 days prior to the study (excluding parkinson’s medications)?
Beschreibung

concomitant medications

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0013227
Drug Name
Beschreibung

Drug Name

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C2360065
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C2348070
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C1519795
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0013153
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0392360
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0808070
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0806020
Ongoing Medication?
Beschreibung

Ongoing Medication?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0549178
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

integer

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

Semi-Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure Diastolic
Beschreibung

Semi-Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Beschreibung

Semi-Supine

Datentyp

integer

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

Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure Diastolic
Beschreibung

Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Beschreibung

Standing

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
NEUROLOGICAL EXAMINATION
Beschreibung

NEUROLOGICAL EXAMINATION

Alias
UMLS CUI-1
C0027853
Mental Status
Beschreibung

Mental Status

Datentyp

integer

Alias
UMLS CUI [1]
C0004936
Mental Status Comment
Beschreibung

Mental Status Comment

Datentyp

text

Alias
UMLS CUI [1]
C0004936
Gait
Beschreibung

Gait

Datentyp

integer

Alias
UMLS CUI [1]
C0016928
Gait Comment
Beschreibung

Gait Comment

Datentyp

text

Alias
UMLS CUI [1]
C0016928
Balance
Beschreibung

Balance

Datentyp

integer

Alias
UMLS CUI [1]
C0560184
Balance Comment
Beschreibung

Balance Comment

Datentyp

text

Alias
UMLS CUI [1]
C0560184
Coordination
Beschreibung

Coordination

Datentyp

integer

Alias
UMLS CUI [1]
C0242414
Coordination Comment
Beschreibung

Coordination Comment

Datentyp

text

Alias
UMLS CUI [1]
C0242414
Cranial nerves
Beschreibung

Cranial nerves

Datentyp

integer

Alias
UMLS CUI [1]
C0010268
Cranial nerves
Beschreibung

Cranial nerves

Datentyp

text

Alias
UMLS CUI [1]
C0010268
Motor
Beschreibung

Motor

Datentyp

integer

Alias
UMLS CUI [1]
C0234130
Motor
Beschreibung

Motor

Datentyp

text

Alias
UMLS CUI [1]
C0234130
Reflexes
Beschreibung

Reflexes

Datentyp

integer

Alias
UMLS CUI [1]
C0034929
Reflexes
Beschreibung

Reflexes

Datentyp

text

Alias
UMLS CUI [1]
C0034929
Sensory
Beschreibung

Sensory

Datentyp

integer

Alias
UMLS CUI [1]
C0682648
Sensory
Beschreibung

Sensory

Datentyp

text

Alias
UMLS CUI [1]
C0682648
Was the neurological examination consistent with the diagnosis of Parkinson’s disease? If NO, the subject is not eligible to participate in the study.
Beschreibung

neurological examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0030567
MODIFIED HOEHN AND YAHR PARKINSON’S DISEASE STAGING
Beschreibung

MODIFIED HOEHN AND YAHR PARKINSON’S DISEASE STAGING

Alias
UMLS CUI-1
C4274318
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]
C0030567
Hoehn and Yahr stage
Beschreibung

Hoehn and Yahr

Datentyp

integer

Alias
UMLS CUI [1]
C4274318
SURGICAL PROCEDURES
Beschreibung

SURGICAL PROCEDURES

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

surgical procedures

Datentyp

boolean

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

Date of procedure

Datentyp

date

Alias
UMLS CUI [1,1]
C2584899
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0030567
Details
Beschreibung

Details

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 [1,1]
C2584899
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0030567
Details
Beschreibung

Details

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 [1,1]
C2584899
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0030567
Details
Beschreibung

Details

Datentyp

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0030567
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 the ECG
Beschreibung

Result of the ECG

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 [1,1]
C0005834
UMLS CUI [1,2]
C0011008
PREGNANCY TEST
Beschreibung

PREGNANCY TEST

Alias
UMLS CUI-1
C0032976
If subject is female and of childbearing potential a serum pregnancy test must be performed.
Beschreibung

pregnancy test

Datentyp

boolean

Alias
UMLS CUI [1]
C0032976
PHYSICAL EXAMINATION PROMPT
Beschreibung

PHYSICAL EXAMINATION PROMPT

Alias
UMLS CUI-1
C0031809
Perform a physical examination on the subject Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the Current Medical Conditions page
Beschreibung

physical examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0031809
ELIGIBILITY QUESTION
Beschreibung

ELIGIBILITY QUESTION

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschreibung

Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
INCLUSION CRITERIA
Beschreibung

INCLUSION CRITERIA

Alias
UMLS CUI-1
C1512693
Men or non-pregnant/non-breast-feeding women of at least 30 years of age at screening. Women of child-bearing potential must be practising a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device [IUD], or diaphram IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception [i.e. Norplant], during the study and for at least one month prior to randomisation and one month following completion of the study.
Beschreibung

age, pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0021359
Diagnosis of idiopathic Parkinson’s Disease (according to modified Hoehn & Yahr criteria Stages IIIV) and demonstrating lack of control with L-dopa therapy (e.g. end of dose akinesia, simple on/off fluctuations)
Beschreibung

Parkinsons Disease L-dopa

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0023570
UMLS CUI [1,3]
C0205179
Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
Beschreibung

L-Dopa

Datentyp

boolean

Alias
UMLS CUI [1]
C0023570
Provide written informed consent for this study.
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Be willing and able to comply with study procedures, including diary card completion and follow-up clinic visits.
Beschreibung

compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1321605
EXCLUSION CRITERIA
Beschreibung

EXCLUSION CRITERIA

Alias
UMLS CUI-1
C0680251
Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinsia on their stable dose of L-dopa.
Beschreibung

Late stage advanced

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0544467
UMLS CUI [1,3]
C0030567
Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than Parkinson’s Disease), or cardiovascular disease or active malignancy (other than basal cell cancer).
Beschreibung

concomitant disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0243087
Recent history of severe dizziness or fainting due to postural hypotension on standing.
Beschreibung

dizziness or fainting

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020651
UMLS CUI [1,2]
C0012833
UMLS CUI [1,3]
C0012833
Clinical dementia that in the judgment of the investigator would preclude assessment of the subject.
Beschreibung

dementia

Datentyp

boolean

Alias
UMLS CUI [1]
C0497327
Recent history or current evidence of drug abuse or alcoholism.
Beschreibung

drug abuse alcoholism

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001940
UMLS CUI [1,2]
C0013146
Consumption of any dopamine agonist within four weeks of the start of the study.
Beschreibung

dopamine agonist

Datentyp

boolean

Alias
UMLS CUI [1]
C0178601
Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude longterm dosing with ropinirole CR;
Beschreibung

hypersensitivity to ropinirole

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0244821
UMLS CUI [1,2]
C0020517
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrolment through the end of the Treatment Period.
Beschreibung

concomitant therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C0282402
UMLS CUI [1,3]
C3899737
Use of an investigational drug within 30 days or 5 half-lives (which ever is longer).
Beschreibung

investigational drug

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
DISPENSING
Beschreibung

DISPENSING

Alias
UMLS CUI-1
C0947323
Dispense placebo run-in medication Record dispensing information in the Investigational Product and Compliance sections at the next visit.
Beschreibung

Dispense

Datentyp

boolean

Alias
UMLS CUI [1]
C0947323
DIARIES
Beschreibung

DIARIES

Alias
UMLS CUI-1
C3890583
Issue the subject with the Week -2 Diary Card
Beschreibung

Week -2 Diary Card

Datentyp

boolean

Alias
UMLS CUI [1]
C3890583
Zum Seitenanfang zurückkehren

Ähnliche Modelle

GSK Ropinirole in Patients Suffering from Parkinsons Disease Screening 101468/169 NCT00381472

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General
C0205246 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
UNIFIED PARKINSON’S DISEASE RATING SCALE
C0030567 (UMLS CUI-1)
C0681889 (UMLS CUI-2)
UNIFIED PARKINSON’S DISEASE RATING SCALE
Item
UNIFIED PARKINSON’S DISEASE RATING SCALE
text
C0030567 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
Item Group
DEMOGRAPHY
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Female (F)
CL Item
Male (M)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
American Hispanic (1)
CL Item
Arabic/North African (2)
CL Item
Black (3)
CL Item
East & South East Asian (4)
CL Item
South Asian (5)
CL Item
White/Caucasian (6)
CL Item
Other (7)
Item Group
PAST MEDICAL CONDITIONS
C0262926 (UMLS CUI-1)
Blood and lymphatic system disorders
Item
Blood and lymphatic system disorders
boolean
C0262926 (UMLS CUI [1,1])
C0851353 (UMLS CUI [1,2])
Blood and lymphatic system disorders
Item
Blood and lymphatic system disorders
text
C0262926 (UMLS CUI [1,1])
C0851353 (UMLS CUI [1,2])
Cardiac disorders
Item
Cardiac disorders
boolean
C0262926 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
Cardiac disorders
Item
Cardiac disorders
text
C0262926 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
Ear and labyrinth disorder
Item
Ear and labyrinth disorder
boolean
C0262926 (UMLS CUI [1,1])
C0851354 (UMLS CUI [1,2])
Ear and labyrinth disorder
Item
Ear and labyrinth disorder
text
C0262926 (UMLS CUI [1,1])
C0851354 (UMLS CUI [1,2])
Endocrine disorders
Item
Endocrine disorders
boolean
C0262926 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
Endocrine disorders
Item
Endocrine disorders
text
C0262926 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
Eye disorders
Item
Eye disorders
boolean
C0262926 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
Eye disorders
Item
Eye disorders
text
C0262926 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
Gastrointestinal disorders
Item
Gastrointestinal disorders
boolean
C0262926 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
Gastrointestinal disorders
Item
Gastrointestinal disorders
text
C0262926 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
Hepatobiliary disorders
Item
Hepatobiliary disorders
boolean
C0262926 (UMLS CUI [1,1])
C0267792 (UMLS CUI [1,2])
Hepatobiliary disorders
Item
Hepatobiliary disorders
text
C0262926 (UMLS CUI [1,1])
C0267792 (UMLS CUI [1,2])
Immune system disorders
Item
Immune system disorders
boolean
C0262926 (UMLS CUI [1,1])
C1334156 (UMLS CUI [1,2])
Immune system disorders
Item
Immune system disorders
text
C0262926 (UMLS CUI [1,1])
C1334156 (UMLS CUI [1,2])
Metabolism and nutrition disorders
Item
Metabolism and nutrition disorders
boolean
C0262926 (UMLS CUI [1,1])
C0851358 (UMLS CUI [1,2])
Metabolism and nutrition disorders
Item
Metabolism and nutrition disorders
text
C0262926 (UMLS CUI [1,1])
C0851358 (UMLS CUI [1,2])
Musculoskeletal and connective tissue disorders
Item
Musculoskeletal and connective tissue disorders
boolean
C0262926 (UMLS CUI [1,1])
C0263660 (UMLS CUI [1,2])
Musculoskeletal and connective tissue disorders
Item
Musculoskeletal and connective tissue disorders
text
C0262926 (UMLS CUI [1,1])
C0263660 (UMLS CUI [1,2])
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
Item
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
boolean
C0262926 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
Item
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
text
C0262926 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
Nervous system disorders
Item
Nervous system disorders
boolean
C0262926 (UMLS CUI [1,1])
C0810273 (UMLS CUI [1,2])
Nervous system disorders
Item
Nervous system disorders
text
C0262926 (UMLS CUI [1,1])
C0810273 (UMLS CUI [1,2])
Psychiatric disorders
Item
Psychiatric disorders
boolean
C0262926 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Psychiatric disorders
Item
Psychiatric disorders
text
C0262926 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Renal and urinary disorders
Item
Renal and urinary disorders
boolean
C0262926 (UMLS CUI [1,1])
C0042075 (UMLS CUI [1,2])
Renal and urinary disorders
Item
Renal and urinary disorders
text
C0262926 (UMLS CUI [1,1])
C0042075 (UMLS CUI [1,2])
Reproductive system and breast disorders
Item
Reproductive system and breast disorders
boolean
C0262926 (UMLS CUI [1,1])
C0851366 (UMLS CUI [1,2])
Reproductive system and breast disorders
Item
Reproductive system and breast disorders
text
C0262926 (UMLS CUI [1,1])
C0851366 (UMLS CUI [1,2])
Respiratory, thoracic and mediastinal disorders
Item
Respiratory, thoracic and mediastinal disorders
boolean
C0262926 (UMLS CUI [1,1])
C0851355 (UMLS CUI [1,2])
Respiratory, thoracic and mediastinal disorders
Item
Respiratory, thoracic and mediastinal disorders
text
C0262926 (UMLS CUI [1,1])
C0851355 (UMLS CUI [1,2])
Skin and subcutaneous tissue disorders
Item
Skin and subcutaneous tissue disorders
boolean
C0262926 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
Skin and subcutaneous tissue disorders
Item
Skin and subcutaneous tissue disorders
text
C0262926 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
Vascular disorders
Item
Vascular disorders
boolean
C0262926 (UMLS CUI [1,1])
C0042373 (UMLS CUI [1,2])
Vascular disorders
Item
Vascular disorders
text
C0262926 (UMLS CUI [1,1])
C0042373 (UMLS CUI [1,2])
Item Group
CURRENT MEDICAL CONDITIONS
C3899485 (UMLS CUI-1)
Blood and lymphatic system disorders
Item
Blood and lymphatic system disorders
boolean
C3899485 (UMLS CUI [1,1])
C0851353 (UMLS CUI [1,2])
Blood and lymphatic system disorders
Item
Blood and lymphatic system disorders
text
C3899485 (UMLS CUI [1,1])
C0851353 (UMLS CUI [1,2])
Cardiac disorders
Item
Cardiac disorders
boolean
C3899485 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
Cardiac disorders
Item
Cardiac disorders
text
C3899485 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
Ear and labyrinth disorder
Item
Ear and labyrinth disorder
boolean
C3899485 (UMLS CUI [1,1])
C0851354 (UMLS CUI [1,2])
Ear and labyrinth disorder
Item
Ear and labyrinth disorder
text
C3899485 (UMLS CUI [1,1])
C0851354 (UMLS CUI [1,2])
Endocrine disorders
Item
Endocrine disorders
boolean
C3899485 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
Endocrine disorders
Item
Endocrine disorders
text
C3899485 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
Eye disorders
Item
Eye disorders
boolean
C3899485 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
Eye disorders
Item
Eye disorders
text
C3899485 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
Gastrointestinal disorders
Item
Gastrointestinal disorders
boolean
C3899485 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
Gastrointestinal disorders
Item
Gastrointestinal disorders
text
C3899485 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
Hepatobiliary disorders
Item
Hepatobiliary disorders
boolean
C3899485 (UMLS CUI [1,1])
C0267792 (UMLS CUI [1,2])
Hepatobiliary disorders
Item
Hepatobiliary disorders
text
C3899485 (UMLS CUI [1,1])
C0267792 (UMLS CUI [1,2])
Immune system disorders
Item
Immune system disorders
boolean
C3899485 (UMLS CUI [1,1])
C1334156 (UMLS CUI [1,2])
Immune system disorders
Item
Immune system disorders
text
C3899485 (UMLS CUI [1,1])
C1334156 (UMLS CUI [1,2])
Metabolism and nutrition disorders
Item
Metabolism and nutrition disorders
boolean
C3899485 (UMLS CUI [1,1])
C0851358 (UMLS CUI [1,2])
Metabolism and nutrition disorders
Item
Metabolism and nutrition disorders
text
C3899485 (UMLS CUI [1,1])
C0851358 (UMLS CUI [1,2])
Musculoskeletal and connective tissue disorders
Item
Musculoskeletal and connective tissue disorders
boolean
C3899485 (UMLS CUI [1,1])
C0263660 (UMLS CUI [1,2])
Musculoskeletal and connective tissue disorders
Item
Musculoskeletal and connective tissue disorders
text
C3899485 (UMLS CUI [1,1])
C0263660 (UMLS CUI [1,2])
Neoplasms benign, malignant and unspecified
Item
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
boolean
C3899485 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
Neoplasms benign, malignant and unspecified
Item
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
text
C3899485 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
Nervous system disorders
Item
Nervous system disorders
boolean
C3899485 (UMLS CUI [1,1])
C0810273 (UMLS CUI [1,2])
Nervous system disorders
Item
Nervous system disorders
text
C3899485 (UMLS CUI [1,1])
C0810273 (UMLS CUI [1,2])
Psychiatric disorders
Item
Psychiatric disorders
boolean
C3899485 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Psychiatric disorders
Item
Psychiatric disorders
text
C3899485 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Renal and urinary disorders
Item
Renal and urinary disorders
boolean
C3899485 (UMLS CUI [1,1])
C0042075 (UMLS CUI [1,2])
Renal and urinary disorders
Item
Renal and urinary disorders
text
C3899485 (UMLS CUI [1,1])
C0042075 (UMLS CUI [1,2])
Reproductive system and breast disorders
Item
Reproductive system and breast disorders
boolean
C3899485 (UMLS CUI [1,1])
C0851366 (UMLS CUI [1,2])
Reproductive system and breast disorders
Item
Reproductive system and breast disorders
text
C3899485 (UMLS CUI [1,1])
C0851366 (UMLS CUI [1,2])
Respiratory, thoracic and mediastinal disorders
Item
Respiratory, thoracic and mediastinal disorders
boolean
C3899485 (UMLS CUI [1,1])
C0851355 (UMLS CUI [1,2])
Respiratory, thoracic and mediastinal disorders
Item
Respiratory, thoracic and mediastinal disorders
text
C3899485 (UMLS CUI [1,1])
C0851355 (UMLS CUI [1,2])
Skin and subcutaneous tissue disorders
Item
Skin and subcutaneous tissue disorders
boolean
C3899485 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
Skin and subcutaneous tissue disorders
Item
Skin and subcutaneous tissue disorders
text
C3899485 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
Vascular disorders
Item
Vascular disorders
boolean
C3899485 (UMLS CUI [1,1])
C0042373 (UMLS CUI [1,2])
Vascular disorders
Item
Vascular disorders
text
C3899485 (UMLS CUI [1,1])
C0042373 (UMLS CUI [1,2])
Item Group
PRIOR PARKINSON’S MEDICATION
C0030567 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Parkinson’s medication
Item
Has the subject taken any prior Parkinson’s medication within 30 days prior to the study (excluding L-Dopa)? If Yes, record each medication on a separate line using Trade Names where possible.
boolean
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Item
Units
text
C0030567 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Units
Code List
Units
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Route
text
C0030567 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Route
Code List
Route
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Reason for Medication
Item
Reason for Medication
text
C0030567 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Start Date
Item
Start Date
date
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Stop Date
Item
Stop Date
date
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C0030567 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Item Group
L-DOPA MEDICATION HISTORY
C0013227 (UMLS CUI-1)
C0023570 (UMLS CUI-2)
start taking L-Dopa
Item
When did the subject first start taking L-Dopa?
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
Item Group
PRIOR OR CONCOMITANT MEDICATIONS
C2347852 (UMLS CUI-1)
C2826257 (UMLS CUI-2)
concomitant medications
Item
Were any concomitant medications taken by the subject within 30 days prior to the study (excluding parkinson’s medications)?
boolean
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Drug Name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2360065 (UMLS CUI [1,4])
Total Daily Dose
Item
Total Daily Dose
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2348070 (UMLS CUI [1,4])
Item
Units
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Units
Code List
Units
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Route
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
Route
Code List
Route
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Reason for Medication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Start Date
Item
Start Date
date
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
Stop Date
Item
Stop Date
date
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
NEUROLOGICAL EXAMINATION
C0027853 (UMLS CUI-1)
Item
Mental Status
integer
C0004936 (UMLS CUI [1])
Mental Status
Code List
Mental Status
CL Item
Normal (1)
CL Item
Abnormal (2)
Mental Status Comment
Item
Mental Status Comment
text
C0004936 (UMLS CUI [1])
Item
Gait
integer
C0016928 (UMLS CUI [1])
Mental Status
Code List
Gait
CL Item
Normal (1)
CL Item
Abnormal (2)
Gait Comment
Item
Gait Comment
text
C0016928 (UMLS CUI [1])
Item
Balance
integer
C0560184 (UMLS CUI [1])
Mental Status
Code List
Balance
CL Item
Normal (1)
CL Item
Abnormal (2)
Balance Comment
Item
Balance Comment
text
C0560184 (UMLS CUI [1])
Item
Coordination
integer
C0242414 (UMLS CUI [1])
Mental Status
Code List
Coordination
CL Item
Normal (1)
CL Item
Abnormal (2)
Coordination Comment
Item
Coordination Comment
text
C0242414 (UMLS CUI [1])
Item
Cranial nerves
integer
C0010268 (UMLS CUI [1])
Mental Status
Code List
Cranial nerves
CL Item
Normal (1)
CL Item
Abnormal (2)
Cranial nerves
Item
Cranial nerves
text
C0010268 (UMLS CUI [1])
Item
Motor
integer
C0234130 (UMLS CUI [1])
Mental Status
Code List
Motor
CL Item
Normal (1)
CL Item
Abnormal (2)
Motor
Item
Motor
text
C0234130 (UMLS CUI [1])
Item
Reflexes
integer
C0034929 (UMLS CUI [1])
Mental Status
Code List
Reflexes
CL Item
Normal (1)
CL Item
Abnormal (2)
Reflexes
Item
Reflexes
text
C0034929 (UMLS CUI [1])
Item
Sensory
integer
C0682648 (UMLS CUI [1])
Mental Status
Code List
Sensory
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Sensory
text
C0682648 (UMLS CUI [1])
Mental Status
Code List
Sensory
neurological examination
Item
Was the neurological examination consistent with the diagnosis of Parkinson’s disease? If NO, the subject is not eligible to participate in the study.
boolean
C0027853 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Item Group
MODIFIED HOEHN AND YAHR PARKINSON’S DISEASE STAGING
C4274318 (UMLS CUI-1)
Date of onset of symptoms of parkinson’s disease
Item
Date of onset of symptoms of parkinson’s disease
date
C0030567 (UMLS CUI [1,1])
Item
Hoehn and Yahr stage
integer
C4274318 (UMLS CUI [1])
Hoehn and Yahr
Code List
Hoehn and Yahr stage
CL Item
Stage 0 No signs of disease. (1)
CL Item
Stage I Unilateral disease. (2)
CL Item
Stage I.5 Unilateral plus axial involvement. (3)
CL Item
Stage 2 Bilateral disease, without impairment of balance. (4)
CL Item
Stage 2.5 Mild Bilateral disease, with recovery on pull test. (5)
CL Item
Stage 3 Mild to moderate bilateral disease, some postural instability; physically independent. (6)
CL Item
Stage 4 Severe disability; still able to walk or stand unassisted. (7)
CL Item
Stage 5 Wheelchair bound or bedridden unless aided. (8)
Item Group
SURGICAL PROCEDURES
C0543467 (UMLS CUI-1)
surgical procedures
Item
Has the subject had any surgical procedures related to Parkinson’s disease?
boolean
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Details
Item
Details
text
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Details
Item
Details
text
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Details
Item
Details
text
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Item Group
12-LEAD ECG
C0430456 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Result of the ECG
integer
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. Complete the current medical conditions page. (3)
Item Group
CENTRAL LABORATORY
C1880016 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
PREGNANCY TEST
C0032976 (UMLS CUI-1)
pregnancy test
Item
If subject is female and of childbearing potential a serum pregnancy test must be performed.
boolean
C0032976 (UMLS CUI [1])
Item Group
PHYSICAL EXAMINATION PROMPT
C0031809 (UMLS CUI-1)
physical examination
Item
Perform a physical examination on the subject Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the Current Medical Conditions page
boolean
C0031809 (UMLS CUI [1])
Item Group
ELIGIBILITY QUESTION
C1516637 (UMLS CUI-1)
entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
INCLUSION CRITERIA
C1512693 (UMLS CUI-1)
age, pregnancy
Item
Men or non-pregnant/non-breast-feeding women of at least 30 years of age at screening. Women of child-bearing potential must be practising a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device [IUD], or diaphram IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception [i.e. Norplant], during the study and for at least one month prior to randomisation and one month following completion of the study.
boolean
C0001779 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0021359 (UMLS CUI [1,3])
Parkinsons Disease L-dopa
Item
Diagnosis of idiopathic Parkinson’s Disease (according to modified Hoehn & Yahr criteria Stages IIIV) and demonstrating lack of control with L-dopa therapy (e.g. end of dose akinesia, simple on/off fluctuations)
boolean
C0030567 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
L-Dopa
Item
Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
boolean
C0023570 (UMLS CUI [1])
informed consent
Item
Provide written informed consent for this study.
boolean
C0021430 (UMLS CUI [1])
compliance
Item
Be willing and able to comply with study procedures, including diary card completion and follow-up clinic visits.
boolean
C2348568 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Item Group
EXCLUSION CRITERIA
C0680251 (UMLS CUI-1)
Late stage advanced
Item
Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinsia on their stable dose of L-dopa.
boolean
C0023570 (UMLS CUI [1,1])
C0544467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
concomitant disease
Item
Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than Parkinson’s Disease), or cardiovascular disease or active malignancy (other than basal cell cancer).
boolean
C0243087 (UMLS CUI [1])
dizziness or fainting
Item
Recent history of severe dizziness or fainting due to postural hypotension on standing.
boolean
C0020651 (UMLS CUI [1,1])
C0012833 (UMLS CUI [1,2])
C0012833 (UMLS CUI [1,3])
dementia
Item
Clinical dementia that in the judgment of the investigator would preclude assessment of the subject.
boolean
C0497327 (UMLS CUI [1])
drug abuse alcoholism
Item
Recent history or current evidence of drug abuse or alcoholism.
boolean
C0001940 (UMLS CUI [1,1])
C0013146 (UMLS CUI [1,2])
dopamine agonist
Item
Consumption of any dopamine agonist within four weeks of the start of the study.
boolean
C0178601 (UMLS CUI [1])
hypersensitivity to ropinirole
Item
Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude longterm dosing with ropinirole CR;
boolean
C0244821 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
concomitant therapy
Item
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrolment through the end of the Treatment Period.
boolean
C1707479 (UMLS CUI [1,1])
C0282402 (UMLS CUI [1,2])
C3899737 (UMLS CUI [1,3])
investigational drug
Item
Use of an investigational drug within 30 days or 5 half-lives (which ever is longer).
boolean
C0013230 (UMLS CUI [1])
Item Group
DISPENSING
C0947323 (UMLS CUI-1)
Dispense
Item
Dispense placebo run-in medication Record dispensing information in the Investigational Product and Compliance sections at the next visit.
boolean
C0947323 (UMLS CUI [1])
Item Group
DIARIES
C3890583 (UMLS CUI-1)
Week -2 Diary Card
Item
Issue the subject with the Week -2 Diary Card
boolean
C3890583 (UMLS CUI [1])
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