Informações:
Falhas:
ID
40863
Descrição
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
Palavras-chave
Versões (2)
- 27/05/2020 27/05/2020 -
- 27/05/2020 27/05/2020 -
Titular dos direitos
GlaxoSmithKline
Transferido a
27 de maio de 2020
DOI
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Licença
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
Similar models
Adverse Event, Serious Adverse Event
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Adverse Event Time Point
integer
C0877248 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])
CL Item
Post-dose (1)
CL Item
+ 2 hrs (2)
CL Item
+ 8 hrs (3)
CL Item
+ 18 hrs (4)
Any Adverse Events?
Item
Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
Item
Adverse Event Time Point
integer
C0877248 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])
CL Item
Pre-dose (1)
CL Item
+ 4 hrs (2)
Any Adverse Events?
Item
Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
Item
Adverse Event Time Point
integer
C0877248 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])
CL Item
Pre-dose (1)
Any Adverse Events?
Item
Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
Item Group
Any Adverse Events? (Follow-up)
C0877248 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C1522577 (UMLS CUI-2)
Have any Adverse events occured since the last visit?
Item
Have any Adverse events occured since the last visit?
boolean
C0877248 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
Item
If no adverse events, please mark box
integer
C0877248 (UMLS CUI [1])
CL Item
No adverse events (1)
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Adverse Event - Onset Date/Time
Item
Adverse Event - Onset Date/Time
datetime
C2985916 (UMLS CUI [1])
C2697889 (UMLS CUI [2])
C2697889 (UMLS CUI [2])
Adverse Event - End Date/Time
Item
Adverse Event - End Date/Time
datetime
C2826793 (UMLS CUI [1])
CL Item
Resolved (1)
CL Item
Ongoing (2)
Item
Adverse Event - Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
CL Item
Intermittent (1)
CL Item
Constant (2)
If intermittent course, enter number of episodes
Item
If intermittent course, enter number of episodes
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0205267 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2,1])
C4086638 (UMLS CUI [2,2])
C0750729 (UMLS CUI [1,2])
C0205267 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2,1])
C4086638 (UMLS CUI [2,2])
Item
Adverse Event - Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Adverse Event - Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Code List
Adverse Event - Action Taken with Respect to Investigational Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Drug stopped (5)
Item
Adverse Event - Relationship to Investigational Drug
integer
C0877248 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Adverse Event - Relationship to Investigational Drug
CL Item
Related (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
CL Item
Unrelated (4)
Adverse Event - Corrective Therapy
Item
Adverse Event - Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Was subject withdrawn due to this AE?
Item
Was subject withdrawn due to this AE?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Item Group
Adverse Event - Investigator’s Signature
C0877248 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
C2346576 (UMLS CUI-2)
Investigator’s Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
Investigator’s Signature Date
Item
Investigator’s Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Person Reporting SAE
Item
Person Reporting SAE
text
C1519255 (UMLS CUI [1])
C0335038 (UMLS CUI [2])
C0335038 (UMLS CUI [2])
AEGIS Number
Item
AEGIS Number
text
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event - Onset Date and Time
Item
Serious Adverse Event - Onset Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Serious Adverse Event - End Date and Time
Item
Serious Adverse Event - End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Serious Adverse Event - Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Serious Adverse Event - Event Course
integer
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
CL Item
Intermittent (1)
CL Item
Constant (2)
Serious Adverse Event - If intermittent course, enter number of episodes
Item
Serious Adverse Event - If intermittent course, enter number of episodes
integer
C1519255 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [2])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [2])
Item
Serious Adverse Event - Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Serious Advrese Event - Action Taken with Respect to Investigational Drug
integer
C1519255 (UMLS CUI [1,1])
C2826626 (UMLS CUI [1,2])
C2826626 (UMLS CUI [1,2])
Code List
Serious Advrese Event - Action Taken with Respect to Investigational Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Drug stopped (5)
Item
Serious Adverse Event - Relationship to Investigational Drug
integer
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Code List
Serious Adverse Event - Relationship to Investigational Drug
CL Item
Related (1)
CL Item
Possible Related (2)
CL Item
Probable unrelated (3)
CL Item
Unrelated (4)
Did the SAE abate?
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
C3853704 (UMLS CUI [1,2])
Serious Adverse Event - If study medication was interrupted, stopped or dose reduced, was study medication reintroduced (or dose increased)?
Item
Serious Adverse Event - If study medication was interrupted, stopped or dose reduced, was study medication reintroduced (or dose increased)?
boolean
C1519255 (UMLS CUI [1])
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])
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])
Serious Adverse Event - If study medication was reintroduced, did SAE recur?
Item
Serious Adverse Event - If study medication was reintroduced, did SAE recur?
boolean
C0013230 (UMLS CUI [1,1])
C0580673 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0580673 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
Item
The SAE is probably associated with
integer
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,2])
CL Item
Protocol design or procedures (but not to study drug), please specify (1)
CL Item
Another condition (eg, condition under study, intercurrent illness), please specify (2)
CL Item
Another drug (3)
If SAE is associated with protocol design or procedures, please specify
Item
If SAE is associated with protocol design or procedures, please specify
text
C1519255 (UMLS CUI [1,1])
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])
C1507394 (UMLS CUI [2,1])
C1507083 (UMLS CUI [2,2])
C2700391 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
If SAE is associated with other condition, specify
Item
If SAE is associated with other condition, specify
text
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0332281 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Serious Adverse Event - Corrective Therapy
Item
Serious Adverse Event - Corrective Therapy
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Was subject withdrawn due to this AE ?
Item
Was subject withdrawn due to this AE ?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a serious AE.
text
C1519255 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
Code List
Specify reason(s) for considering this a serious AE.
CL Item
results in Death (A)
CL Item
life threatening (B)
CL Item
requires hospitalisation or prolongationof existing hospitalization (C)
CL Item
results in disability/incapacity (D)
CL Item
congenital anomaly/birth defect (E)
CL Item
other (see definition) (F)
Specify other reason(s) for considering this a serious AE.
Item
Specify other reason(s) for considering this a serious AE.
text
C1519255 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Serious Adverse Event - Relevant Laboratory Data
C1519255 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Laboratory Test
Item
Laboratory Test
text
C0022885 (UMLS CUI [1])
Laboratory Test Date
Item
Laboratory Test Date
date
C2826641 (UMLS CUI [1])
Laboratory Test Value
Item
Laboratory Test Value
float
C0587081 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,2])
Laboratory Test - Units
Item
Laboratory Test - Units
text
C0022885 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Laboratory Test - Normal Range
Item
Laboratory Test - Normal Range
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,2])
Relevant Laboratory Data - Remarks
Item
Relevant Laboratory Data - Remarks
text
C0022885 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
If applicable, was randomisation code broken at investigational site?
Item
If applicable, was randomisation code broken at investigational site?
boolean
C0034656 (UMLS CUI [1,1])
C3899531 (UMLS CUI [1,2])
C3899531 (UMLS CUI [1,2])
Randomisation/Study Medication Number:
Item
Randomisation/Study Medication Number:
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - Investigator's Signature
C1519255 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
C2346576 (UMLS CUI-2)
Investigator’s Signature:
Item
Investigator’s Signature:
text
C2346576 (UMLS CUI [1])
Investigator's Name
Item
Investigator's Name
text
C2826892 (UMLS CUI [1])
Investigator’s Signature Date
Item
Investigator’s Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])