ID

29075

Descrição

Study ID: 101468/249 Clinical Study ID: 101468/249 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: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome; Restless Legs Syndrome (RLS)

Palavras-chave

Versões (1)
  1. 23/02/2018 23/02/2018 -
Titular dos direitos

GlaxoSmithKline (GSK)

Transferido a

23 de fevereiro de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

  • Os mais recentes
  • Os mais antigos
  • Preferidos
  • Os mais recentes
    • Os mais recentes
    • Os mais antigos
    • Preferidos

Sem comentários

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857

Inglês

Scales, baseline signs and symptoms

1 Formulários  
Scales RLS
Descrição

Scales RLS

Alias
UMLS CUI-1
C0450973
UMLS CUI-2
C0035258
Please complete the information below based on the Baseline IRLS Rating Scale. If this score is not ≥ 15, exclude the patient
Descrição

IRLS Rating Scale

Tipo de dados

integer

Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale • Hospital Anxiety and Depression Scale (HADS)
Descrição

If the patient is eligible to continue in the study please continue the assessments for this visit as stated below:

Tipo de dados

boolean

Vital signs
Descrição

Vital signs

Alias
UMLS CUI-1
C0518766
Pulse (after 5 minutes sitting)
Descrição

Pulse

Tipo de dados

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Sitting Blood Pressure (after 5 minutes sitting) systolic / diastolic
Descrição

Blood pressure

Tipo de dados

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
Descrição

Concomitant medication

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347852
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
Descrição

Medical Procedures

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0199171
Baseline signs and symptoms
Descrição

Baseline signs and symptoms

Alias
UMLS CUI-1
C0037088
If you consider this to be a serious baseline event (SBE), please do not enter on this page but enter in the Serious Adverse Experience section (SAE) (See opposite for definitions of an SBE)
Descrição

Serious baseline events

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519255
Please mark this box if no baseline events occurred prior to randomisation into study.
Descrição

Baseline events

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0877248
Baseline signs and symptoms
Descrição

Baseline signs and symptoms

Alias
UMLS CUI-1
C0037088
Onset Date and Time
Descrição

Onset Date and Time

Tipo de dados

datetime

Alias
UMLS CUI [1]
C2826806
End Date and Time (If ongoing please leave blank)
Descrição

End Date and Time

Tipo de dados

datetime

Alias
UMLS CUI [1]
C2826793
Outcome If patient died, STOP: go to SAE section and follow instructions given there
Descrição

Outcome

Tipo de dados

integer

Alias
UMLS CUI [1]
C1705586
Event Course
Descrição

Event Course

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Event Course, if 'intermittent' please specify No. of episodes:
Descrição

Event Course

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Intensity (maximum)
Descrição

INTENSITY (Maximum) MILD An event which is easily tolerated MODERATE An event which is sufficiently discomforting to interfere with daily activities SEVERE An event which prevents normal everyday activities

Tipo de dados

integer

Alias
UMLS CUI [1]
C1710066
Relationship to study procedures performed prior to randomisation
Descrição

RELATIONSHIP TO STUDY PROCEDURES RELATED There is a direct cause and effect relationship between the event and the study procedures POSSIBLY RELATED A direct cause and effect relationship between the study procedures and the event has not been demonstrated but is possible or likely PROBABLY UNRELATED Cause and effect relationship between the study procedures and the event has not been demonstrated, is improbable but not impossible UNRELATED The event is definitely not related to the study procedures

Tipo de dados

integer

Alias
UMLS CUI [1]
C1510821
Corrective Therapy
Descrição

If ‘Yes’, record details in Prior and Concomitant Medication section and/or Health Care Resource Utilisation section if appropriate.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific event?
Descrição

Withdrawal related to adverse event

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0877248
Ramos Randomisation and Dispensing
Descrição

Ramos Randomisation and Dispensing

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0947323
Randomisation number:
Descrição

Randomisation number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Container numbers:
Descrição

Container numbers

Tipo de dados

integer

Alias
UMLS CUI [1]
C0180098
Orthostatic vital signs
Descrição

Orthostatic vital signs

Alias
UMLS CUI-1
C0518766
Orthostatic vital signs
Descrição

Orthostatic vital signs

Tipo de dados

integer

Alias
UMLS CUI [1]
C0518766
Reading
Descrição

Reading

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0034754
Time of dose
Descrição

Time of dose

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Time Vitals Taken
Descrição

Time Vitals Taken

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Blood pressure systolic/diastolic
Descrição

Blood pressure

Tipo de dados

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse
Descrição

Pulse

Tipo de dados

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Voltar ao início da página

Similar models

Scales, baseline signs and symptoms

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Scales RLS
C0450973 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
IRLS Rating Scale
Item
Please complete the information below based on the Baseline IRLS Rating Scale. If this score is not ≥ 15, exclude the patient
integer
Patient rated scales
Item
Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale • Hospital Anxiety and Depression Scale (HADS)
boolean
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Pulse
Item
Pulse (after 5 minutes sitting)
integer
C0232117 (UMLS CUI [1])
Blood pressure
Item
Sitting Blood Pressure (after 5 minutes sitting) systolic / diastolic
integer
C0005823 (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])
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
C0199171 (UMLS CUI [1])
Item Group
Baseline signs and symptoms
C0037088 (UMLS CUI-1)
Serious baseline events
Item
If you consider this to be a serious baseline event (SBE), please do not enter on this page but enter in the Serious Adverse Experience section (SAE) (See opposite for definitions of an SBE)
boolean
C1519255 (UMLS CUI [1])
Baseline events
Item
Please mark this box if no baseline events occurred prior to randomisation into study.
boolean
C0877248 (UMLS CUI [1])
Item Group
Baseline signs and symptoms
C0037088 (UMLS CUI-1)
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time (If ongoing please leave blank)
datetime
C2826793 (UMLS CUI [1])
Item
Outcome If patient died, STOP: go to SAE section and follow instructions given there
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome If patient died, STOP: go to SAE section and follow instructions given there
CL Item
[1] Resolved (1)
CL Item
[2] Ongoing (2)
CL Item
[3] Died (3)
Item
Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Event Course
Code List
Event Course
CL Item
[1] Intermittent (1)
CL Item
[2] Constant (2)
Event Course
Item
Event Course, if 'intermittent' please specify No. of episodes:
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity (maximum)
CL Item
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
Item
Relationship to study procedures performed prior to randomisation
integer
C1510821 (UMLS CUI [1])
Relationship to study procedures
Code List
Relationship to study procedures performed prior to randomisation
CL Item
[5] Related (1)
CL Item
[6] Possibly related (2)
CL Item
[7] Probably unrelated (3)
CL Item
[1] Unrelated (4)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Withdrawal related to adverse event
Item
Was patient withdrawn due to this specific event?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
Ramos Randomisation and Dispensing
C0034656 (UMLS CUI-1)
C0947323 (UMLS CUI-2)
Randomisation number
Item
Randomisation number:
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Container numbers
Item
Container numbers:
integer
C0180098 (UMLS CUI [1])
Item Group
Orthostatic vital signs
C0518766 (UMLS CUI-1)
Item
Orthostatic vital signs
integer
C0518766 (UMLS CUI [1])
Orthostatic vital signs
Code List
Orthostatic vital signs
CL Item
After 10 minutes semi-supine (1)
CL Item
After erect for 1 minute (2)
Item
Reading
integer
C0456984 (UMLS CUI [1,1])
C0034754 (UMLS CUI [1,2])
Reading
Code List
Reading
CL Item
Pre-Dose Reading (1)
CL Item
2 hours Post-Dose Reading (2)
Time of dose
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Time Vitals Taken
Item
Time Vitals Taken
date
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood pressure
Item
Blood pressure systolic/diastolic
integer
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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