ID

29075

Descrizione

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)

Keywords

versioni (1)
  1. 23/02/18 23/02/18 -
Titolare del copyright

GlaxoSmithKline (GSK)

Caricato su

23 febbraio 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

  • i più nuovi
  • i più vecchi
  • Popolare
  • i più nuovi
    • i più nuovi
    • i più vecchi
    • Popolare

Non ci sono commenti

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

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

Inglese

Scales, baseline signs and symptoms

1 moduli  
Scales RLS
Descrizione

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
Descrizione

IRLS Rating Scale

Tipo di dati

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)
Descrizione

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

Tipo di dati

boolean

Vital signs
Descrizione

Vital signs

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

Pulse

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Sitting Blood Pressure (after 5 minutes sitting) systolic / diastolic
Descrizione

Blood pressure

Tipo di dati

integer

Unità di misura
  • 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.
Descrizione

Concomitant medication

Tipo di dati

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.
Descrizione

Medical Procedures

Tipo di dati

boolean

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

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)
Descrizione

Serious baseline events

Tipo di dati

boolean

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

Baseline events

Tipo di dati

boolean

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

Baseline signs and symptoms

Alias
UMLS CUI-1
C0037088
Onset Date and Time
Descrizione

Onset Date and Time

Tipo di dati

datetime

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

End Date and Time

Tipo di dati

datetime

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

Outcome

Tipo di dati

integer

Alias
UMLS CUI [1]
C1705586
Event Course
Descrizione

Event Course

Tipo di dati

integer

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

Event Course

Tipo di dati

integer

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

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 di dati

integer

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

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 di dati

integer

Alias
UMLS CUI [1]
C1510821
Corrective Therapy
Descrizione

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

Tipo di dati

boolean

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

Withdrawal related to adverse event

Tipo di dati

boolean

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

Ramos Randomisation and Dispensing

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

Randomisation number

Tipo di dati

integer

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

Container numbers

Tipo di dati

integer

Alias
UMLS CUI [1]
C0180098
Orthostatic vital signs
Descrizione

Orthostatic vital signs

Alias
UMLS CUI-1
C0518766
Orthostatic vital signs
Descrizione

Orthostatic vital signs

Tipo di dati

integer

Alias
UMLS CUI [1]
C0518766
Reading
Descrizione

Reading

Tipo di dati

integer

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

Time of dose

Tipo di dati

time

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

Time Vitals Taken

Tipo di dati

date

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

Blood pressure

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse
Descrizione

Pulse

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Ritorna all'inizio della pagina

Similar models

Scales, baseline signs and symptoms

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Aiuto

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