ID
40786
Beschreibung
Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome
Stichworte
Versionen (1)
- 13.05.20 13.05.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
13. Mai 2020
DOI
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Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218
Concomitant Medication; Adverse Event; Serious Adverse Event
- StudyEvent: ODM
Beschreibung
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
If ’YES’, please record all medications used below. Where appropriate, medical conditions should be recorded on the Adverse Events Form, utilizing the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0443172
Beschreibung
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
(Trade Name Preferred)
Datentyp
text
Alias
- UMLS CUI [1]
- C2360065
Beschreibung
(eg.500mg)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1960417
- UMLS CUI [1,2]
- C0869039
Beschreibung
(e.g.BID,PRN)
Datentyp
text
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
Concomitant Medication Route
Datentyp
text
Alias
- UMLS CUI [1]
- C2826730
Beschreibung
Concomitant Medication Indication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826696
Beschreibung
Concomitant Medication Start Date/Time
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826825
Beschreibung
Concomitant Medication End Date/Time
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826815
Beschreibung
Concomitant Medication continuing at end of Study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Beschreibung
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Beschreibung
Adverse Event
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Adverse Event - Onset Date/Time
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2985916
- UMLS CUI [2]
- C2697889
Beschreibung
(If ongoing, please leave blank)
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826793
Beschreibung
Adverse Event - Outcome
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
Adverse Event - Event Course
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschreibung
If intermittent course, enter number of episodes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
- UMLS CUI [1,3]
- C0205267
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C4086638
Beschreibung
Adverse Event - Intensity (maximum)
Datentyp
integer
Alias
- UMLS CUI [1]
- C1710066
Beschreibung
Adverse Event - Action Taken with Respect to Investigational Drug
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826626
Beschreibung
Adverse Event - Relationship to Investigational Drug
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
If "Yes", Please record on Concomitant Medication form
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschreibung
Was subject withdrawn due to this AE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0877248
Beschreibung
Advrese Event - Investigator’s Signature
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2346576
Beschreibung
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Person Reporting SAE
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C0335038
Beschreibung
Serious Adverse Event
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Serious Adverse Event - Onset Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1301880
Beschreibung
Serious Adverse Event - End Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1522314
Beschreibung
Serious Adverse Event - Outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschreibung
Serious Adverse Event - Event Course
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0750729
Beschreibung
Serious Adverse Event - If intermittent course, enter number of episodes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205267
- UMLS CUI [2]
- C4086638
Beschreibung
(maximum)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
Beschreibung
Serious Advrese Event - Action Taken with Respect to Investigational Drug
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826626
Beschreibung
Serious Adverse Event - Relationship to Investigational Drug
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0013230
Beschreibung
Did the SAE abate?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Beschreibung
Serious Adverse Event - If study medication was interrupted, stopped or dose reduced, was study medication reintroduced (or dose increased)?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C1512900
- UMLS CUI [3]
- C0850893
- UMLS CUI [4,1]
- C0304229
- UMLS CUI [4,2]
- C1707814
- UMLS CUI [5,1]
- C0013230
- UMLS CUI [5,2]
- C0580673
Beschreibung
Serious Adverse Event - If study medication was reintroduced, did SAE recur?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C0580673
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Beschreibung
The SAE is probably associated with
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
Beschreibung
If SAE is associated with protocol design or procedures, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [2,1]
- C1507394
- UMLS CUI [2,2]
- C1507083
- UMLS CUI [3]
- C2700391
- UMLS CUI [4]
- C2348235
Beschreibung
If SAE is associated with other condition, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [2]
- C2348235
Beschreibung
If ’Yes’,Please record on Concomitant Medication form
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0087111
Beschreibung
Was subject withdrawn due to this AE ?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0877248
Beschreibung
Mark all that apply.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0566251
Beschreibung
Specify other reason(s) for considering this a serious AE.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
Beschreibung
Serious Adverse Event - Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0022885
Beschreibung
Laboratory Test
Datentyp
text
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Laboratory Test Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826641
Beschreibung
Laboratory Test Value
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
Beschreibung
Laboratory Test - Units
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1519795
Beschreibung
Laboratory Test - Normal Range
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0086715
Beschreibung
(Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0947611
Beschreibung
If applicable, was randomisation code broken at investigational site?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C3899531
Beschreibung
Randomisation/Study Medication Number:
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschreibung
Serious Adverse Event - Investigator's Signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Beschreibung
(confirming that the above data are accurate and complete)
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator's Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Investigator’s Signature Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
Concomitant Medication; Adverse Event; Serious Adverse Event
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,2])
C0869039 (UMLS CUI [1,2])
C2697889 (UMLS CUI [2])
C0750729 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C0205267 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2,1])
C4086638 (UMLS CUI [2,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C2346576 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0335038 (UMLS CUI [2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C1705586 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C2826626 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C3853704 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1512900 (UMLS CUI [2,2])
C0850893 (UMLS CUI [3])
C0304229 (UMLS CUI [4,1])
C1707814 (UMLS CUI [4,2])
C0013230 (UMLS CUI [5,1])
C0580673 (UMLS CUI [5,2])
C0580673 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0332281 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,2])
C1507394 (UMLS CUI [2,1])
C1507083 (UMLS CUI [2,2])
C2700391 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
C0332281 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0087111 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0022885 (UMLS CUI-2)
C1522609 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C3899531 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C2346576 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])