ID
40829
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)
- 5/19/20 5/19/20 -
- 5/20/20 5/20/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 20, 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)
Significant Medical/ Surgical History; Physical Examination; Pregnancy Test
Description
Significant Medical/ Surgical History (Period 1 Day -1)
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
Description
If Yes, List below one diagnosis per line. (Please print clearly) Only in the absence of a diagnosis, record the signs and symptoms on separate lines.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0543467
Description
Significant Medical/ Surgical History (Period 2 Day -1)
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
Description
If Yes, List below one diagnosis per line. (Please print clearly) Only in the absence of a diagnosis, record the signs and symptoms on separate lines.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0543467
Description
Significant Medical/ Surgical History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
Description
Diagnosis
Data type
text
Alias
- UMLS CUI [1]
- C0011900
Description
Year of first diagnosis
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0439234
- UMLS CUI [1,2]
- C0011900
Description
Diagnosis status
Data type
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0449438
Description
Physical Examination (Period 1 Day -1)
Alias
- UMLS CUI-1
- C0031809
Description
Physical Examination - Date
Data type
date
Alias
- UMLS CUI [1]
- C2826643
Description
Physical Examination - Time
Data type
time
Alias
- UMLS CUI [1]
- C2826761
Description
If Yes, record below. Any clinically relevant worsening since the last exam must be recorded on the Adverse Events page.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0443172
Description
Physical Examination - Change
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0443172
Description
Physical Examination (Period 2 Day -1)
Alias
- UMLS CUI-1
- C0031809
Description
Physical Examination - Date
Data type
date
Alias
- UMLS CUI [1]
- C2826643
Description
Physical Examination - Time
Data type
time
Alias
- UMLS CUI [1]
- C2826761
Description
If Yes, record below. Any clinically relevant worsening since the last exam must be recorded on the Adverse Events page.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0443172
Description
Physical Examination - Change
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0443172
Description
Physical Examination (Follow-Up)
Alias
- UMLS CUI-1
- C0031809
Description
Physical Examination - Date
Data type
date
Alias
- UMLS CUI [1]
- C2826643
Description
Physical Examination - Time
Data type
time
Alias
- UMLS CUI [1]
- C2826761
Description
If Yes, record below. Any clinically relevant worsening since the last exam must be recorded on the Adverse Events page.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0443172
Description
Physical Examination - Change
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0443172
Description
Physical Examination - Investigator's Signature
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C2346576
Description
Pregnancy Test (Females only)
Alias
- UMLS CUI-1
- C0032976
Description
Was a pregnancy test carried out?
Data type
boolean
Alias
- UMLS CUI [1]
- C0032976
Description
If no pregnancy test has been carried out, please specify reason
Data type
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C2826287
Description
Date and time of pregnancy test
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Description
If ’Positive’, withdraw the subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0427777
Description
Please mark box for test type
Data type
integer
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0332307
Description
If other test type, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
ensure result is included on laboratory report
Data type
text
Alias
- UMLS CUI [1]
- C1882331
Similar models
Significant Medical/ Surgical History; Physical Examination; Pregnancy Test
C0489540 (UMLS CUI-2)
C0543467 (UMLS CUI [1,2])
C0489540 (UMLS CUI-2)
C0543467 (UMLS CUI [1,2])
C0489540 (UMLS CUI-2)
C0011900 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,2])
C2346576 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])