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Falhas:
ID
29007
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)
- 20/02/2018 20/02/2018 -
Titular dos direitos
GlaxoSmithKline (GSK)
Transferido a
20 de fevereiro de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857
RLS history and diagnostic criteria
- StudyEvent: ODM
Similar models
RLS history and diagnostic criteria
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Age of Patient at first symptoms
Item
How old was the patient at the onset of RLS?
integer
C0150907 (UMLS CUI [1])
Item
Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
text
C0277793 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Code List
Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
CL Item
No (N)
CL Item
Yes (Y)
Medication
Item
If ’Yes’ please specify medication(s)
text
C0013227 (UMLS CUI [1])
Item
If female, did RLS symptoms develop during pregnancy?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not applicable (X)
Item
Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?
text
C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0035258 (UMLS CUI [2])
C0037313 (UMLS CUI [1,2])
C0035258 (UMLS CUI [2])
Code List
Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?
CL Item
No (N)
CL Item
Yes (Y)
Onset of PLMS
Item
How old was the patient at the onset of PLMS? Years (in whole years)
integer
C0206132 (UMLS CUI [1,1])
C0596840 (UMLS CUI [1,2])
C0037313 (UMLS CUI [2,1])
C0035258 (UMLS CUI [2,2])
C0596840 (UMLS CUI [1,2])
C0037313 (UMLS CUI [2,1])
C0035258 (UMLS CUI [2,2])
CL Item
No (N)
CL Item
Yes (Y)
Alcohol Units/week
Item
Units/week
integer
C0001948 (UMLS CUI [1])
Item
Does the patient drink caffeine (coffee, tea, caffeinated drinks)?
text
C0948365 (UMLS CUI [1])
CL Item
No (N)
CL Item
Yes (Y)
Caffeine Cups/day
Item
Cups/day
integer
C0948365 (UMLS CUI [1])
Item
Does the patient have any sleep disorder as defined by DSM IV excluding RLS?
text
C0851578 (UMLS CUI [1])
Code List
Does the patient have any sleep disorder as defined by DSM IV excluding RLS?
CL Item
No (N)
CL Item
Yes (Y)
Item
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
text
C0241889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
Code List
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown (U)
Item
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever ... been diagnosed with or had symptoms of PLMS?
text
C0241889 (UMLS CUI [1,1])
C0596840 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0596840 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
Code List
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever ... been diagnosed with or had symptoms of PLMS?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown (U)
Item
Are the patient’s current symptoms mainly present..
integer
C1457887 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
CL Item
At nightime only (1)
CL Item
In evening and nightime (2)
CL Item
Daytime, evening and nightime (3)
Item Group
RLS Diagnostic Criteria
C0035258 (UMLS CUI-1)
C0679228 (UMLS CUI-2)
C0679228 (UMLS CUI-2)
limb movement associated with paresthesias or dysesthesias
Item
A desire to move the limbs usually associated with paresthesias or dysesthesias
boolean
C0035258 (UMLS CUI [1,1])
C0596840 (UMLS CUI [1,2])
C0030554 (UMLS CUI [1,3])
C0392699 (UMLS CUI [1,4])
C0596840 (UMLS CUI [1,2])
C0030554 (UMLS CUI [1,3])
C0392699 (UMLS CUI [1,4])
motor restlessness
Item
motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort)
boolean
C0700075 (UMLS CUI [1])
Symptoms at rest
Item
symptoms worse or exclusively present at rest with at least partial and temporal relief by activity
boolean
C1457887 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
C0035253 (UMLS CUI [1,2])
Symptoms in the evening or night
Item
symptoms worse in the evening or night
boolean
C3176727 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])