ID

26489

Descripción

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.

Palabras clave

Versiones (2)
  1. 11/10/17 11/10/17 -
  2. 18/10/17 18/10/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

18 de octubre de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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

Inglés

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

1 formularios  
General Information
Descripción

General Information

Alias
UMLS CUI-1
C1508263
Centre Number
Descripción

Centre Number

Tipo de datos

text

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

Patient Number

Tipo de datos

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Descripción

Patient Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
RLS RATING SCALE
Descripción

RLS RATING SCALE

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

RLS RATING SCALE

Tipo de datos

boolean

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

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Pulse
Descripción

after 5 minutes sitting

Tipo de datos

integer

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

after 5 minutes sitting

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting Blood Pressure diastolic
Descripción

after 5 minutes sitting

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
MEDICAL PROCEDURES
Descripción

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.
Descripción

MEDICAL PROCEDURES

Tipo de datos

boolean

CONCOMITANT MEDICATION
Descripción

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.
Descripción

CONCOMITANT MEDICATION

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
ADVERSE EXPERIENCES
Descripción

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.
Descripción

ADVERSE EXPERIENCES

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0877248
LABORATORY EVALUATION
Descripción

LABORATORY EVALUATION

Alias
UMLS CUI-1
C0022885
Date of blood sample
Descripción

Date of blood sample

Tipo de datos

date

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

laboratory abnormalities

Tipo de datos

integer

Alias
UMLS CUI [1]
C1853129
URINE DIPSTICK
Descripción

URINE DIPSTICK

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

Urine Dipstick

Tipo de datos

integer

Alias
UMLS CUI [1]
C0430370
Volver a la parte superior de la página

Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial