ID

26489

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 mandatory 7 day follow-up assessment form.

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  1. 11.10.17 11.10.17 -
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GlaxoSmithKline

Hochgeladen am

18. Oktober 2017

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Follow-Up GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

Englisch

Follow-Up GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

1 Formulare  
General Information
Beschreibung

General Information

Alias
UMLS CUI-1
C1508263
Centre Number
Beschreibung

Centre Number

Datentyp

text

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

Patient Number

Datentyp

text

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
RLS RATING SCALE
Beschreibung

RLS RATING SCALE

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C0035258
RLS RATING SCALE
Beschreibung

RLS RATING SCALE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
VITAL SIGNS
Beschreibung

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Pulse
Beschreibung

after 5 minutes sitting

Datentyp

integer

Alias
UMLS CUI [1]
C0232117
Sitting Blood Pressure systolic
Beschreibung

after 5 minutes sitting

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting Blood Pressure diastolic
Beschreibung

after 5 minutes sitting

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
MEDICAL PROCEDURES
Beschreibung

MEDICAL PROCEDURES

Alias
UMLS CUI-1
C0199171
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
Beschreibung

MEDICAL PROCEDURES

Datentyp

boolean

CONCOMITANT MEDICATION
Beschreibung

CONCOMITANT MEDICATION

Alias
UMLS CUI-1
C2347852
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
Beschreibung

CONCOMITANT MEDICATION

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
ADVERSE EXPERIENCES
Beschreibung

ADVERSE EXPERIENCES

Alias
UMLS CUI-1
C0877248
Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.
Beschreibung

ADVERSE EXPERIENCES

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
LABORATORY EVALUATION
Beschreibung

LABORATORY EVALUATION

Alias
UMLS CUI-1
C0022885
Date of blood sample
Beschreibung

Date of blood sample

Datentyp

date

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

laboratory abnormalities

Datentyp

integer

Alias
UMLS CUI [1]
C1853129
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]
C0430370
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Ähnliche Modelle

Follow-Up 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)
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
RLS RATING SCALE
C0681889 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
RLS RATING SCALE
Item
RLS RATING SCALE
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Sitting Blood Pressure systolic
Item
Sitting Blood Pressure systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting Blood Pressure diastolic
Item
Sitting Blood Pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
MEDICAL PROCEDURES
C0199171 (UMLS CUI-1)
MEDICAL PROCEDURES
Item
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
boolean
Item Group
CONCOMITANT MEDICATION
C2347852 (UMLS CUI-1)
CONCOMITANT MEDICATION
Item
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
boolean
C2347852 (UMLS CUI [1])
Item Group
ADVERSE EXPERIENCES
C0877248 (UMLS CUI-1)
ADVERSE EXPERIENCES
Item
Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.
boolean
C0877248 (UMLS CUI [1])
Item Group
LABORATORY EVALUATION
C0022885 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Were any clinically significant abnormalities detected?
integer
C1853129 (UMLS CUI [1])
laboratory abnormalities
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes - If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this book and repeat at Follow-up. (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])
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 in the Adverse Experiences and/or SAE Section at the back of this book, send a sample to Quest Diagnostics for further evaluation and repeat at Follow-up. (2)
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