Informationen:
Fehler:
ID
25725
Beschreibung
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 Follow-Up
Stichworte
Versionen (1)
- 13.09.17 13.09.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
13. September 2017
DOI
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Creative Commons BY-NC-ND 3.0
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Follow-Up GSK Ropinirole Restless Legs Syndrome 101468
Follow-Up GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
Ähnliche Modelle
Follow-Up GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Visit Day
Item
Visit Day
date
C2827038 (UMLS CUI [1])
Pregnancy test
Item
Was a pregnancy test carried out?
boolean
C0032976 (UMLS CUI [1])
pregnancy Test Reason
Item
If NO, please specify reason
text
C0430060 (UMLS CUI [1])
Date of Pregnancy Test
Item
If 'YES', pease indicate date of result:
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Vital Signs - Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measurments 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 study nurse/operator should conduct all the blood pressure measurements for each clinic visit.
C0518766 (UMLS CUI-1)
Date of Examination: Pre-Dose
Item
Date
date
C2826643 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,2])
Time of Examination: Pre-Dose
Item
Time
time
C0040223 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Semi-supine Systolic Blood Pressure
Item
Semi-supine Blood Pressure: Systolic
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
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
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
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
float
C0522014 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
Erect Heart Rate
Item
Erect Heart Rate
float
C0522014 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Item Group
12 Lead ECG Monitoring - Please affix ECG trace to this page.
C0430456 (UMLS CUI-1)
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 Duration
Item
QRS
float
C1880451 (UMLS CUI [1])
QTc Interval
Item
QTc
float
C0489625 (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 Comments
Item
Comments*
text
C1623258 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Item Group
Labaroty Collections: Clinical Chemistry & Haematology - Ensure
C0008000 (UMLS CUI-1)
C0474523 (UMLS CUI-3)
C0474523 (UMLS CUI-3)
Date of Blood Sampling
Item
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of Blood Sampling
Item
Exact time of blood sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Clinical Chemistry & Hematology: Comments
Item
Comments
text
C0008000 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0474523 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C0947611 (UMLS CUI [1,2])
C0474523 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
Clinical Chemistry & Hematology: Clinically significant
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
boolean
C0008000 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C0474523 (UMLS CUI [2,1])
C2826633 (UMLS CUI [2,2])
C2826633 (UMLS CUI [1,2])
C0474523 (UMLS CUI [2,1])
C2826633 (UMLS CUI [2,2])
Item Group
Laboratory Collections: Drug Screening (Urine)
C0202274 (UMLS CUI-1)
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 Screening
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
C3845816 (UMLS CUI [1])
Type of contraindicated drug
Item
If YES, please record all the relevant contra-indicated drugs below. Type of drug
text
C0457591 (UMLS CUI [1,1])
C3845816 (UMLS CUI [1,2])
C3845816 (UMLS CUI [1,2])
Comment: Contraindicated Drug
Item
If YES, please record all the relevant contraindicated drugs below. Comment
text
C0947611 (UMLS CUI [1,1])
C3845816 (UMLS CUI [1,2])
C3845816 (UMLS CUI [1,2])
Item Group
Urinanalysis - Ensure a urine sample has been taken for urine dipstick.
C0042014 (UMLS CUI-1)
Date of Urine Sample
Item
Exact date of urine sampling
date
C2371162 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of Urine Sampling
Item
Exact time of urine sampling
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Urinanalysis: Comment
Item
Comments:
text
C0947611 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
Urinanalysis: Clinically Significant
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
boolean
C2826633 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
Urine pH
Item
Results for dip stick test: pH
float
C0042044 (UMLS CUI [1])
Urine pH: Clinically Significant
Item
Results for dip stick test: pH Clinically Significant
boolean
C2826633 (UMLS CUI [1,1])
C0042044 (UMLS CUI [1,2])
C0042044 (UMLS CUI [1,2])
Urine pH: Comment
Item
Results for dip stick test: 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
float
C0262923 (UMLS CUI [1])
Urine Protein: Clinically Significant
Item
Results for dip stick test: Protein Clinically Significant
boolean
C2826633 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
C0262923 (UMLS CUI [1,2])
Urine Protein: Comment
Item
Results for dip stick test: Protein Comments
text
C0947611 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
C0262923 (UMLS CUI [1,2])
Urine Glucose
Item
Results for dip stick test: Glucose
float
C0004076 (UMLS CUI [1])
Urine Glucose: Clinically Significant
Item
Results for dip stick test: Glucose Clinically Significant
boolean
C2826633 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
C0004076 (UMLS CUI [1,2])
Urine Glucose: Comment
Item
Results for dip stick test: Glucose Comment
text
C0947611 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
C0004076 (UMLS CUI [1,2])
Urine Bilirubin
Item
Results for dip stick test: Bilirubin
float
C0042040 (UMLS CUI [1])
Urine Bilirubin: Clinically Significant
Item
Results for dip stick test: Bilirubin Clinically Significant
boolean
C2826633 (UMLS CUI [1,1])
C0042040 (UMLS CUI [1,2])
C0042040 (UMLS CUI [1,2])
Urine Bilirubin: Comment
Item
Results for dip stick test: Bilirubin Comment
text
C0947611 (UMLS CUI [1,1])
C0042040 (UMLS CUI [1,2])
C0042040 (UMLS CUI [1,2])
Hematuria
Item
Results for dip stick test: Blood
float
C0018965 (UMLS CUI [1])
Hematuria: Clinically Significant
Item
Results for dip stick test: Blood Clinically Significant
boolean
C2826633 (UMLS CUI [1,1])
C0018965 (UMLS CUI [1,2])
C0018965 (UMLS CUI [1,2])
Hematuria: Comment
Item
Results for dip stick test: Blood Comment
text
C0947611 (UMLS CUI [1,1])
C0018965 (UMLS CUI [1,2])
C0018965 (UMLS CUI [1,2])
CL Item
Not applicable (not of childbearing potential or male) (X)
CL Item
No (N)
CL Item
Yes (Y)
Completed
Item
Did the subject complete the study as planned?
boolean
C0205197 (UMLS CUI [1])
Item
Did the subject complete the study as planned? If 'NO', mark the one most appropriate category
integer
C2349954 (UMLS CUI [1])
Code List
Did the subject complete the study as planned? If 'NO', mark the one most appropriate category
CL Item
Adverse Event (complete Adverse Event Form) (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Deviation from Protocol (including non-compliance) (3)
CL Item
Lost to Follow-Up (4)
CL Item
Other (5)
Withdrawal: Specification
Item
Did the subject complete the study as planned? If 'NO', mark the one most appropriate category. If 'Other', please specify
text
C2349954 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Withdrawal: Comment
Item
Comments on reason for withdrawal
text
C0947611 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
Date of Withrawal
Item
Date of Withdrawal
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of Withdrawal
Item
Time of Withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Date of Final Dose
Item
Date of Final Dose
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Time of Final Dose
Item
Time of Final Dose
time
C0013227 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Item Group
Adverse Event - Please note any SERIOUS events should NOT be recorded on this page, but on the SERIOUS ADVERSE EVENT pages provided. Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient 'How are you feeling' (pre-dose) and at subsequent schedules intervals post dose: 'Since you were last asked have you felt unwell or different from usual?'
C0877248 (UMLS CUI-1)
Adverse Event
Item
If no adverse events, please mark box and sign form below.
boolean
C0877248 (UMLS CUI [1])
Adverse Event: Specification
Item
Adverse Event
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Onset Date
Item
Onset Date
date
C0574845 (UMLS CUI [1])
Onset Time
Item
Onset Time
time
C0449244 (UMLS CUI [1])
End Date
Item
End Date (If ongoing, please leave blank)
date
C0806020 (UMLS CUI [1])
End Time
Item
End Time (If ongoing, please leave blank)
time
C1522314 (UMLS CUI [1])
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
Number of Episodes
Item
Event Course If Intermittent, specify No. of episodes
float
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Non (Non)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Drug interrupted/restarted (Drug interrupted/restarted)
CL Item
Drug stopped (Drug stopped)
CL Item
Related (Related)
CL Item
Possibly related (Possibly related)
CL Item
Probably related (Probably related)
CL Item
Unrelated (Unrelated)
Corrective Therapy
Item
Corrective Therapy. If 'YES', please record on Concomitant Medication form.
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Withdrawal due to Adverse Event
Item
Was subject due to this AE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
Investigator's Statement
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
C1710187 (UMLS CUI-2)
CL Item
Check all Adverse Event forms are upt to date and complete (Check all Adverse Event forms are upt to date and complete)
CL Item
Check that the Concomitant Medication form is up to date (Check that the Concomitant Medication form is up to date)
CL Item
Check that all appropriate pages are signed (thus indicating completion) and dated (Check that all appropriate pages are signed (thus indicating completion) and dated)
CL Item
Check that laboratory results are included (Check that laboratory results are included)
Investigator's Signature
Item
I certify that the observation and findings are recorded correctly and completely in this CRF.
text
C2346576 (UMLS CUI [1])
Date of report
Item
Date
date
C1302584 (UMLS CUI [1])