Information:
Fel:
ID
24445
Beskrivning
Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen 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 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome Screening
Nyckelord
Versioner (1)
- 2017-08-01 2017-08-01 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
1 augusti 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC-ND 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Screening GSK Ropinirole Restless Legs Syndrome 101468
Screening GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
Similar models
Screening GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Date of Report
Item
Date of Interview
date
C1302584 (UMLS CUI [1])
Item Group
Restless Legs Syndrome Diagnostic Criteria - The International RLS Study Group Criteria* defines RLS patients as having. Answer to all four diagnostic criteria must be yes for the patient to be diagnosed with RLS.
C0035258 (UMLS CUI-1)
C0679228 (UMLS CUI-2)
C0679228 (UMLS CUI-2)
Limb movement
Item
1. a desire to move the limbs usually associated with paresthesias or dysesthesias
boolean
C0596840 (UMLS CUI [1])
Motor Restlessness
Item
2. 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
3. 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])
Worsening in night
Item
4. symptoms worse in the evening or night
boolean
C0332271 (UMLS CUI [1,1])
C0240526 (UMLS CUI [1,2])
C0240526 (UMLS CUI [1,2])
Item Group
Medical History and Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-3)
C0031809 (UMLS CUI-3)
Comorbidity
Item
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
boolean
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Date of First Diagnosis
Item
Year of first diagnosis
date
C2316983 (UMLS CUI [1])
Past Medical History
Item
Past
boolean
C0262926 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C0549178 (UMLS CUI [1])
Smoking Status
Item
Is the subject a smoker?
boolean
C1519386 (UMLS CUI [1])
Smoking Years
Item
Number of years the subject has been a smoker?
float
C1277691 (UMLS CUI [1])
Cigarettes per day
Item
Average number of cigarettes smoked per day?
float
C3694146 (UMLS CUI [1])
Tobacco product
Item
Please state what type of tobacoo product (e.g. pipe, cigar, chewing tobacco or cigarette)
text
C3166496 (UMLS CUI [1])
Pharmacotherapy for RLS
Item
Has the patient taken any pharmacotherapy medication for treatment of RLS?
boolean
C0013216 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
Drug name
Item
Drug Name (Trade Name Preferred)
text
C0013227 (UMLS CUI [1])
Start Date
Item
Start Date (be as precise as possible)
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Ongoing
Item
or if Continuing mark box
boolean
Item
Did the patient respond to the treatment? (mark one)
text
C0521982 (UMLS CUI [1])
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Date of Measurement
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
Semi-supine Systolic Blood Pressure
Item
Semi-supine Blood Pressure: Systolic (Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measuremnts will be taken after the patients has been erect for a period of 1 min. - The blood pressure curff must be placed on the same arm throughout the study. - The same sutdy nurse/operator should conduct all the blood pressure measurements for each clinic visit. - Ideally, the same study nurse/operator should conduct ALL the blood pressure measurements for each patient throughout the study.
float
C0522019 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,2])
Semi-supine Diastolic Blood Pressure
Item
Semi-supine Blood Pressure: Diastolic (Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measuremnts will be taken after the patients has been erect for a period of 1 min. - The blood pressure curff must be placed on the same arm throughout the study. - The same sutdy nurse/operator should conduct all the blood pressure measurements for each clinic visit. - Ideally, the same study nurse/operator should conduct ALL the blood pressure measurements for each patient throughout the study.)
float
C0522019 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
Semi-supine Heart Rate
Item
Semi-supine Heart Rate (Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measuremnts will be taken after the patients has been erect for a period of 1 min. - The blood pressure curff must be placed on the same arm throughout the study. - The same sutdy nurse/operator should conduct all the blood pressure measurements for each clinic visit. - Ideally, the same study nurse/operator should conduct ALL the blood pressure measurements for each patient throughout the study.)
float
C0522019 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Erect Systolic Blood Pressure
Item
Erect Blood Pressure: Systolic (Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measuremnts will be taken after the patients has been erect for a period of 1 min. - The blood pressure curff must be placed on the same arm throughout the study. - The same sutdy nurse/operator should conduct all the blood pressure measurements for each clinic visit. - Ideally, the same study nurse/operator should conduct ALL the blood pressure measurements for each patient throughout the study. Repeat the erect measurement IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.)
float
C0522014 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,2])
Erect Diastolic Blood Pressure
Item
Erect Blood Pressure: Diastolic (Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measuremnts will be taken after the patients has been erect for a period of 1 min. - The blood pressure cuff must be placed on the same arm throughout the study. - The same sutdy nurse/operator should conduct all the blood pressure measurements for each clinic visit. - Ideally, the same study nurse/operator should conduct ALL the blood pressure measurements for each patient throughout the study. Repeat the erect measurement IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.)
float
C0522014 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
Erect Heart Rate
Item
Erect Heart Rate (Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measuremnts will be taken after the patients has been erect for a period of 1 min. - The blood pressure cuff must be placed on the same arm throughout the study. - The same sutdy nurse/operator should conduct all the blood pressure measurements for each clinic visit. - Ideally, the same study nurse/operator should conduct ALL the blood pressure measurements for each patient throughout the study. Repeat the erect measurement IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.)
float
C0522014 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Date of ECG
Item
Date
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Actual Time
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
float
C0018810 (UMLS CUI [1])
PR Interval
Item
PR
float
C0429087 (UMLS CUI [1])
QRS Interval
Item
QRS
float
C1880451 (UMLS CUI [1])
QTC Interval
Item
QTC
float
C0855331 (UMLS CUI [1])
ECG clinically significant
Item
ECG clinically significant?
boolean
C1623258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
ECG Comment
Item
Comments*
text
C0947611 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,2])
Item Group
Laboratory Collections - Clinical Chemistry & Haematology: Ensure a blood sample has been taken for clinical chemistry and haematology
C0008000 (UMLS CUI-1)
C0474523 (UMLS CUI-3)
C0474523 (UMLS CUI-3)
Date of Collection
Item
Exact date of blood sampling
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of Collection
Item
Exact time of blood sampling
time
Comment
Item
Comments:
text
C0947611 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2,1])
C0474523 (UMLS CUI [2,2])
C0008000 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2,1])
C0474523 (UMLS CUI [2,2])
Clinical Chemistry & Haematology: Abnormal Findings
Item
Are there clinically significant abnormal values?
boolean
C1704258 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0474523 (UMLS CUI [2,2])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0474523 (UMLS CUI [2,2])
Date of Drug Screening
Item
Exact date of sampling
date
C0011008 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
C0202274 (UMLS CUI [1,2])
Time of Drug Screeing
Item
Exact time of sampling
time
C0040223 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
C0202274 (UMLS CUI [1,2])
Contraindicated Drug
Item
Were there any contra-indicated drugs detected?
boolean
C1444657 (UMLS CUI [1,1])
C4036061 (UMLS CUI [1,2])
C4036061 (UMLS CUI [1,2])
Type of Drug
Item
Type of Drug
text
C0457591 (UMLS CUI [1])
Drug Screening Comment
Item
Comment
text
C0202274 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Item Group
Urinanalyis Test Results -Ensure a urine sample has been taken for urine dipstick
C0042014 (UMLS CUI-1)
Date of Urinanalysis
Item
Exact date of urine sampling
date
C0042014 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of Urinanalysis
Item
Exact time of urine sampling
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Urinanalysis abnormality
Item
Are there clinically significant abnormal values?
boolean
C0042014 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Urine pH
Item
Results for dip stick test: pH
text
C0042044 (UMLS CUI [1])
Urine pH: Clinically Significant
Item
Urine pH: Clinically Significant
boolean
C0042044 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Urine pH: Comment
Item
Urine pH: Comments
text
C0947611 (UMLS CUI [1,1])
C0042044 (UMLS CUI [1,2])
C0042044 (UMLS CUI [1,2])
Urine Protein
Item
Results for dip stick test: Protein
text
C0262923 (UMLS CUI [1])
Urine Protein: Clinically Significant
Item
Urine Protein: Clinically Significant
boolean
C2826633 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
C0262923 (UMLS CUI [1,2])
Urine Glucose
Item
Results for dip stick test: Urine Glucose
text
C0004076 (UMLS CUI [1])
Urine Glucose: Clinically Significant
Item
Urine Glucose: Clinically Significant
boolean
C0004076 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Urine Glucose: Comment
Item
Urine Glucose: Comments
text
C0004076 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Urine Bilirubin
Item
Results for dip stick test: Urine Bilirubin
text
C0042040 (UMLS CUI [1])
Urine Bilirubin: Clinically Significant
Item
Urine Bilirubin: Clinically Significant
boolean
C0042040 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Urine Bilirubin: Comments
Item
Urine Bilirubin: Comments
text
C0042040 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Hematuria
Item
Results for dip stick test: Urine Blood
text
C0018965 (UMLS CUI [1])
Hematuria: Clinically Significant
Item
Urine Blood: Clinically Significant
boolean
C0018965 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Hematuria: Comments
Item
Blood Urine: Comments
text
C0018965 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Pregnancy Test
Item
Was a pregancy test carried out?
boolean
C0032976 (UMLS CUI [1])
Reason
Item
If 'NO', please specify reason:
text
C0392360 (UMLS CUI [1])
Date of Pregnany Test
Item
If 'YES', please indicate date of result:
date
C0011008 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)