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Erreur:
ID
24042
Description
Module 2 - Screening & Repeat Tests 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 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
Mots-clés
Versions (1)
- 23/07/2017 23/07/2017 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
23 juillet 2017
DOI
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Licence
Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests
GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests
Similar models
GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
systolic blood pressure sitting
Item
Sitting systolic Blood Pressure
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
diastolic blood pressure sitting
Item
Sitting diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
laboratory label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C4273937 (UMLS CUI [1])
Item
Were any clinically significant abnormalities detected?
integer
C0005834 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
CL Item
yes (1)
CL Item
no (2)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
CL Item
Positive (2)
CL Item
Negative (1)
Item
Is the patient a female of child-bearing potential?
integer
C1960468 (UMLS CUI [1])
CL Item
no (1 )
CL Item
yes (2 )
Item
Pregnancy dipstick result
integer
C0430056 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
CL Item
negative (1)
CL Item
positive (2)
Item
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
integer
C0199171 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0430022 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C0087111 (UMLS CUI [2])
C0430022 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
Code List
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
CL Item
No (1 )
CL Item
Yes (2)
Procedure
Item
Procedure
text
C0199171 (UMLS CUI [1])
Indication of medical procedure
Item
Indication
text
C0199171 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
Procedure Start Date
Item
Procedure Start Date
date
C0199171 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
End Date Procedure
Item
End Date Procedure
date
C0199171 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item Group
Prior and concomitant medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Item
Has the patient taken any medication (including any pharmacotherapy medication for treatment of RLS) since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
integer
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Code List
Has the patient taken any medication (including any pharmacotherapy medication for treatment of RLS) since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
CL Item
no (1 )
CL Item
yes (2 )
Item Group
prior and concomitant medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Drug name
Item
Drug Name (Trade name preferred)
text
C0013227 (UMLS CUI [1,1])
C0919189 (UMLS CUI [1,2])
C0919189 (UMLS CUI [1,2])
Total Daily Dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1])
Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1])
start date of medication
Item
Start Date (be as precise as possible)
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
End Date of medication
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
medication is current
Item
Does the medication still continue?
boolean
C0013227 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Item Group
Baseline signs and symptoms
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
C1442488 (UMLS CUI-2)
Baseline adverse reaction
Item
Please mark this box if no baseline events occurred prior to randomisation into study.
boolean
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
Baseline adverse reaction
Item
Baseline event
text
C0559546 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
Adverse Reaction Start Date Time
Item
Onset Date and Time
datetime
C2981441 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
Adverse Reaction End Date Time
Item
End Date and Time
datetime
C2981425 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
CL Item
resolved (1)
CL Item
ongoing (2)
CL Item
died (3)
Item
Event Course
integer
C0559546 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
CL Item
intermittent (1)
CL Item
constant (2)
Number of episodes of adverse reaction
Item
Number of episodes
integer
C0559546 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C0559546 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Item
Relationship to study procedures performed prior to enrolment
integer
C0877248 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
C1510821 (UMLS CUI [1,2])
Code List
Relationship to study procedures performed prior to enrolment
CL Item
Related (5)
CL Item
Possibly related (6)
CL Item
Probably unrelated (7)
CL Item
Unrelated (1)
Item
Corrective Therapy
integer
C0559546 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
CL Item
yes (1)
CL Item
no (2)
Item
Was patient withdrawn due to this specific event prior to randomisation?
integer
C2348568 (UMLS CUI [1,1])
C0559546 (UMLS CUI [1,2])
C0424092 (UMLS CUI [1,3])
C0559546 (UMLS CUI [1,2])
C0424092 (UMLS CUI [1,3])
Code List
Was patient withdrawn due to this specific event prior to randomisation?
CL Item
yes (1)
CL Item
no (2)
Item Group
Significant medical/surgical history and physical examination
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-3)
C0031809 (UMLS CUI-5)
C0489540 (UMLS CUI-3)
C0031809 (UMLS CUI-5)
Item
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
integer
C0012634 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0008976 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Code List
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
CL Item
No (1)
CL Item
Yes (2)
Item Group
Significant medical/surgical history and physical examination
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Diagnosis
Item
text
C0011900 (UMLS CUI [1])
Year of diagnosis
Item
Year of first diagnosis (if know)
partialDate
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Item
Past and/or ongoing (diagnosis)
integer
C0011900 (UMLS CUI [1,1])
C0455458 (UMLS CUI [1,2])
C2826680 (UMLS CUI [2])
C0455458 (UMLS CUI [1,2])
C2826680 (UMLS CUI [2])
CL Item
Past (1)
CL Item
ongoing (2)
CL Item
past+ongoing (3)
Item Group
Patient continuation/ withdrawal
C2348568 (UMLS CUI-1)
Item
Is the patient continuing in the study?
integer
C2348568 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
Item
Cause of withdrawal from study
text
C0422727 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
CL Item
Baseline sign and symptom (please complete Baseline Signs and Symptoms page) (1)
CL Item
Does not meet inclusion/exclusion criteria (10)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other-specify: (7)
Other cause of withdrawal from study
Item
Please specify 'other' cause of withdrawal from study.
text
C0422727 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Repeated Laboratory Evaluation
C0022877 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
C0205341 (UMLS CUI-2)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Laboratory label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C4273937 (UMLS CUI [1])
Item
Were any clinically significant abnormalities detected?
integer
C0005834 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
CL Item
yes (1)
CL Item
no (2)
Item Group
Repeated Urine dipstick
C0430370 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
C0205341 (UMLS CUI-2)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
CL Item
Positive (2)
CL Item
Negative (1)