ID

26476

Beschreibung

Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). 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: Requip Study Indication: Restless Legs Syndrome This is the Screening Repeat Tests form.

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  1. 03.10.17 03.10.17 -
  2. 18.10.17 18.10.17 -
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GlaxoSmithKline

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18. Oktober 2017

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Screening Repeat Tests GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

Englisch

Screening Repeat Tests GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

1 Formulare  
General Information
Beschreibung

General Information

Alias
UMLS CUI-1
C1508263
UMLS CUI-2
C1955348
UMLS CUI-3
C0035258
Centre Number
Beschreibung

Centre Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Number
Beschreibung

Patient Number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
ONLY COMPLETE THE FOLLOWING IF THERE WERE ABNORMAL FINDINGS AT THE SCREENING VISIT
Beschreibung

ABNORMAL FINDINGS

Datentyp

boolean

Alias
UMLS CUI [1]
C1704258
ELECTROCARDIOGRAM (12 LEAD)
Beschreibung

ELECTROCARDIOGRAM (12 LEAD)

Alias
UMLS CUI-1
C0013798
Date of ECG
Beschreibung

Date of ECG

Datentyp

date

Alias
UMLS CUI [1]
C2826640
Were any clinically significant abnormalities detected?
Beschreibung

ecg abnormalities

Datentyp

integer

Alias
UMLS CUI [1]
C0522055
PHYSICAL EXAMINATION
Beschreibung

PHYSICAL EXAMINATION

Alias
UMLS CUI-1
C0031809
If any abnormality was present at screening please perform a physical examination. If there are any significant abnormal findings record details in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study.
Beschreibung

abnormal findings

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1704258
LABORATORY EVALUATION
Beschreibung

LABORATORY EVALUATION

Alias
UMLS CUI-1
C0022885
Date of sample
Beschreibung

Date of sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Were any clinically significant abnormalities detected?
Beschreibung

Were any clinically significant abnormalities detected?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1704258
URINE DIPSTICK
Beschreibung

URINE DIPSTICK

Alias
UMLS CUI-1
C0430370
What was the result of the urine dipstick performed at this visit?
Beschreibung

urine dipstick

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C1274040
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Ähnliche Modelle

Screening Repeat Tests GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
C1955348 (UMLS CUI-2)
C0035258 (UMLS CUI-3)
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
ABNORMAL FINDINGS
Item
ONLY COMPLETE THE FOLLOWING IF THERE WERE ABNORMAL FINDINGS AT THE SCREENING VISIT
boolean
C1704258 (UMLS CUI [1])
Item Group
ELECTROCARDIOGRAM (12 LEAD)
C0013798 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Were any clinically significant abnormalities detected?
integer
C0522055 (UMLS CUI [1])
ecg abnormalities
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes - If ’Yes’, please record details in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study. (2)
Item Group
PHYSICAL EXAMINATION
C0031809 (UMLS CUI-1)
abnormal findings
Item
If any abnormality was present at screening please perform a physical examination. If there are any significant abnormal findings record details in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study.
boolean
C0031809 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
LABORATORY EVALUATION
C0022885 (UMLS CUI-1)
Date of sample
Item
Date of sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Were any clinically significant abnormalities detected?
integer
C0005834 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Were any clinically significant abnormalities detected?
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes - If ‘Yes’, please record the findings and/or diagnosis in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study. (2)
Item Group
URINE DIPSTICK
C0430370 (UMLS CUI-1)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
urine dipstick
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Negative (1)
CL Item
Positive - If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and send a sample to Quest Diagnostics for further evaluation. (2)
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