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40828
Beschreibung
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
Stichworte
Versionen (3)
- 19.05.20 19.05.20 -
- 20.05.20 20.05.20 -
- 27.09.21 27.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
20. Mai 2020
DOI
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Creative Commons BY-NC 4.0
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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)
Pharmacogenetic Research; Prior Medication; Baseline Signs and Symptoms
Ähnliche Modelle
Pharmacogenetic Research; Prior Medication; Baseline Signs and Symptoms
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Has informed consent been obtained for Pharmacogenetic Research?
Item
Has informed consent been obtained for Pharmacogenetic Research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,2])
If informed consent has been obtained for Pharmacogenetic Research, record date
Item
If informed consent has been obtained for Pharmacogenetic Research, record date
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If informed consent has not been obtained for Pharmacogenetic Research, check one reason
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
Code List
If informed consent has not been obtained for Pharmacogenetic Research, check one reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
If other reason for informed consent has not been obtained for Pharmacogenetic Research, specify
Item
If other reason for informed consent has not been obtained for Pharmacogenetic Research, specify
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Has a blood sample been collected for Pharmacogenetic Research?
Item
Has a blood sample been collected for Pharmacogenetic Research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
If a blood sample has been collected for Pharmacogenetic Research, record date
Item
If a blood sample has been collected for Pharmacogenetic Research, record date
date
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has this subject withdrawn consent for Pharmacogenetic Research?
Item
Has this subject withdrawn consent for Pharmacogenetic Research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
If a request has been made for sample destruction, check one reason
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Code List
If a request has been made for sample destruction, check one reason
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
If other reason for request for sample destruction, specify
Item
If other reason for request for sample destruction, specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Item
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
boolean
C2826257 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,4])
C0013230 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,4])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
SINGLE Dose/ Unit
Item
SINGLE Dose/ Unit
text
C1960417 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
CL Item
intra-articular (IA)
CL Item
intra-arterial (IAR)
CL Item
intra-dermal (ID)
CL Item
inhalation (IH)
CL Item
intra-muscular (IM)
CL Item
intra-thecal (IT)
CL Item
intra-venous (IV)
CL Item
nasal (NA)
CL Item
oral (PO)
CL Item
rectal (PR)
CL Item
subcutaneous (SC)
CL Item
sublingual (SL)
CL Item
transdermal (TD)
CL Item
topical (TO)
CL Item
vaginal (VA)
Medication Indication
Item
Medication Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Duration of Therapy
Item
Duration of Therapy
text
C0444917 (UMLS CUI [1])
Medication End Date
Item
Medication End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Medication continuing at end of study?
Item
Medication continuing at end of study?
boolean
C1553904 (UMLS CUI [1])
Item Group
Baseline Signs and Symptoms
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
C1442488 (UMLS CUI-2)
Baseline Sign/ Symptom
Item
Baseline Sign/ Symptom
text
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
Signs/ Symptoms Onset Date and Time
Item
Signs/ Symptoms Onset Date and Time
datetime
C0037088 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
Signs/ Symptoms End Date and Time
Item
Signs/ Symptoms End Date and Time
datetime
C0037088 (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
Signs/ Symptoms Outcome
integer
C0037088 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
C1547647 (UMLS CUI [1,2])
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Signs/ Symptoms Event Course
integer
C0037088 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
C0750729 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
CL Item
Intermittent (1)
CL Item
Constant (2)
If intermittent Course, record number of episodes
Item
If intermittent Course, record number of episodes
integer
C0750729 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to study procedures performed prior to randomisation
integer
C2700391 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Not related (1)
CL Item
Unlikely (2)
CL Item
Suspected (3)
CL Item
Probable (4)
Signs/ Symptoms Corrective Therapy
Item
Signs/ Symptoms Corrective Therapy
boolean
C0037088 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Was subject withdrawn due to this event?
Item
Was subject withdrawn due to this event?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Item Group
Baseline Signs and Symptoms - Investigator's Signature
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
C2346576 (UMLS CUI-3)
C1442488 (UMLS CUI-2)
C2346576 (UMLS CUI-3)
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])