ID
40863
Description
Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 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
Keywords
Versions (2)
- 5/27/20 5/27/20 -
- 5/27/20 5/27/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 27, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)
Adverse Event, Serious Adverse Event
- StudyEvent: ODM
Description
Any Adverse Events?
Alias
- UMLS CUI-1
- C0877248
Description
Any Adverse Events?
Alias
- UMLS CUI-1
- C0877248
Description
Any Adverse Events?
Alias
- UMLS CUI-1
- C0877248
Description
Any Adverse Events? (Follow-up)
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1522577
Description
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Description
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Description
Adverse Event
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Adverse Event - Onset Date/Time
Data type
datetime
Alias
- UMLS CUI [1]
- C2985916
- UMLS CUI [2]
- C2697889
Description
(If ongoing, please leave blank)
Data type
datetime
Alias
- UMLS CUI [1]
- C2826793
Description
Adverse Event - Outcome
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
Adverse Event - Event Course
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
If intermittent course, enter number of episodes
Data type
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
Description
Adverse Event - Intensity (maximum)
Data type
integer
Alias
- UMLS CUI [1]
- C1710066
Description
Adverse Event - Action Taken with Respect to Investigational Drug
Data type
integer
Alias
- UMLS CUI [1]
- C2826626
Description
Adverse Event - Relationship to Investigational Drug
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
If "Yes", Please record on Concomitant Medication form
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
Was subject withdrawn due to this AE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0877248
Description
Adverse Event - Investigator’s Signature
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2346576
Description
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Description
Person Reporting SAE
Data type
text
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C0335038
Description
AEGIS Number
Data type
text
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0600091
Description
Serious Adverse Event
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
Serious Adverse Event - Onset Date and Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1301880
Description
Serious Adverse Event - End Date and Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1522314
Description
Serious Adverse Event - Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
Serious Adverse Event - Event Course
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0750729
Description
Serious Adverse Event - If intermittent course, enter number of episodes
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205267
- UMLS CUI [2]
- C4086638
Description
(maximum)
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
Description
Serious Advrese Event - Action Taken with Respect to Investigational Drug
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826626
Description
Serious Adverse Event - Relationship to Investigational Drug
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0013230
Description
Did the SAE abate?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Description
Serious Adverse Event - If study medication was interrupted, stopped or dose reduced, was study medication reintroduced (or dose increased)?
Data type
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
Description
Serious Adverse Event - If study medication was reintroduced, did SAE recur?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C0580673
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Description
The SAE is probably associated with
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
Description
If SAE is associated with protocol design or procedures, please specify
Data type
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
Description
If SAE is associated with other condition, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [2]
- C2348235
Description
If ’Yes’,Please record on Concomitant Medication form
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0087111
Description
Was subject withdrawn due to this AE ?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0877248
Description
Mark all that apply.
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0566251
Description
Specify other reason(s) for considering this a serious AE.
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
Description
Serious Adverse Event - Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0022885
Description
Laboratory Test
Data type
text
Alias
- UMLS CUI [1]
- C0022885
Description
Laboratory Test Date
Data type
date
Alias
- UMLS CUI [1]
- C2826641
Description
Laboratory Test Value
Data type
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
Description
Laboratory Test - Units
Data type
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1519795
Description
Laboratory Test - Normal Range
Data type
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0086715
Description
(Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary)
Data type
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0947611
Description
If applicable, was randomisation code broken at investigational site?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C3899531
Description
Randomisation/Study Medication Number:
Data type
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Description
Serious Adverse Event - Investigator's Signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Description
(confirming that the above data are accurate and complete)
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's Name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator’s Signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Adverse Event, Serious Adverse Event
- StudyEvent: ODM
C2348792 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
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])
C0600091 (UMLS CUI [1,2])
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])