ID
40786
Descripción
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
Palabras clave
Versiones (1)
- 13/5/20 13/5/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
13 de mayo de 2020
DOI
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Licencia
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
Descripción
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0443172
Descripción
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Descripción
(Trade Name Preferred)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2360065
Descripción
(eg.500mg)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1960417
- UMLS CUI [1,2]
- C0869039
Descripción
(e.g.BID,PRN)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3476109
Descripción
Concomitant Medication Route
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826730
Descripción
Concomitant Medication Indication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826696
Descripción
Concomitant Medication Start Date/Time
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C2826825
Descripción
Concomitant Medication End Date/Time
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C2826815
Descripción
Concomitant Medication continuing at end of Study?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2826666
Descripción
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Descripción
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Descripción
Adverse Event
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0877248
Descripción
Adverse Event - Onset Date/Time
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C2985916
- UMLS CUI [2]
- C2697889
Descripción
(If ongoing, please leave blank)
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C2826793
Descripción
Adverse Event - Outcome
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1705586
Descripción
Adverse Event - Event Course
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Descripción
If intermittent course, enter number of episodes
Tipo de datos
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
Descripción
Adverse Event - Intensity (maximum)
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1710066
Descripción
Adverse Event - Action Taken with Respect to Investigational Drug
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2826626
Descripción
Adverse Event - Relationship to Investigational Drug
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Descripción
If "Yes", Please record on Concomitant Medication form
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Descripción
Was subject withdrawn due to this AE?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0877248
Descripción
Advrese Event - Investigator’s Signature
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2346576
Descripción
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Descripción
Person Reporting SAE
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C0335038
Descripción
Serious Adverse Event
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
Descripción
Serious Adverse Event - Onset Date and Time
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1301880
Descripción
Serious Adverse Event - End Date and Time
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1522314
Descripción
Serious Adverse Event - Outcome
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Descripción
Serious Adverse Event - Event Course
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0750729
Descripción
Serious Adverse Event - If intermittent course, enter number of episodes
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205267
- UMLS CUI [2]
- C4086638
Descripción
(maximum)
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
Descripción
Serious Advrese Event - Action Taken with Respect to Investigational Drug
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826626
Descripción
Serious Adverse Event - Relationship to Investigational Drug
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0013230
Descripción
Did the SAE abate?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Descripción
Serious Adverse Event - If study medication was interrupted, stopped or dose reduced, was study medication reintroduced (or dose increased)?
Tipo de datos
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
Descripción
Serious Adverse Event - If study medication was reintroduced, did SAE recur?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C0580673
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Descripción
The SAE is probably associated with
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
Descripción
If SAE is associated with protocol design or procedures, please specify
Tipo de datos
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
Descripción
If SAE is associated with other condition, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [2]
- C2348235
Descripción
If ’Yes’,Please record on Concomitant Medication form
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0087111
Descripción
Was subject withdrawn due to this AE ?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0877248
Descripción
Mark all that apply.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0566251
Descripción
Specify other reason(s) for considering this a serious AE.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
Descripción
Serious Adverse Event - Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0022885
Descripción
Laboratory Test
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0022885
Descripción
Laboratory Test Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826641
Descripción
Laboratory Test Value
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
Descripción
Laboratory Test - Units
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1519795
Descripción
Laboratory Test - Normal Range
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0086715
Descripción
(Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0947611
Descripción
If applicable, was randomisation code broken at investigational site?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C3899531
Descripción
Randomisation/Study Medication Number:
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Descripción
Serious Adverse Event - Investigator's Signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Descripción
(confirming that the above data are accurate and complete)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator's Name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Investigator’s Signature Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
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])