ID
40829
Descripción
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
Palabras clave
Versiones (2)
- 19/5/20 19/5/20 -
- 20/5/20 20/5/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
20 de mayo de 2020
DOI
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Licencia
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
Descripción
Significant Medical/ Surgical History (Period 1 Day -1)
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0543467
Descripción
Significant Medical/ Surgical History (Period 2 Day -1)
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0543467
Descripción
Significant Medical/ Surgical History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
Descripción
Diagnosis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011900
Descripción
Year of first diagnosis
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C0439234
- UMLS CUI [1,2]
- C0011900
Descripción
Diagnosis status
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0449438
Descripción
Physical Examination (Period 1 Day -1)
Alias
- UMLS CUI-1
- C0031809
Descripción
Physical Examination - Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826643
Descripción
Physical Examination - Time
Tipo de datos
time
Alias
- UMLS CUI [1]
- C2826761
Descripción
If Yes, record below. Any clinically relevant worsening since the last exam must be recorded on the Adverse Events page.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0443172
Descripción
Physical Examination - Change
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0443172
Descripción
Physical Examination (Period 2 Day -1)
Alias
- UMLS CUI-1
- C0031809
Descripción
Physical Examination - Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826643
Descripción
Physical Examination - Time
Tipo de datos
time
Alias
- UMLS CUI [1]
- C2826761
Descripción
If Yes, record below. Any clinically relevant worsening since the last exam must be recorded on the Adverse Events page.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0443172
Descripción
Physical Examination - Change
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0443172
Descripción
Physical Examination (Follow-Up)
Alias
- UMLS CUI-1
- C0031809
Descripción
Physical Examination - Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826643
Descripción
Physical Examination - Time
Tipo de datos
time
Alias
- UMLS CUI [1]
- C2826761
Descripción
If Yes, record below. Any clinically relevant worsening since the last exam must be recorded on the Adverse Events page.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0443172
Descripción
Physical Examination - Change
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0443172
Descripción
Physical Examination - Investigator's Signature
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C2346576
Descripción
Pregnancy Test (Females only)
Alias
- UMLS CUI-1
- C0032976
Descripción
Was a pregnancy test carried out?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0032976
Descripción
If no pregnancy test has been carried out, please specify reason
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C2826287
Descripción
Date and time of pregnancy test
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Descripción
If ’Positive’, withdraw the subject from the study.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0427777
Descripción
Please mark box for test type
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0332307
Descripción
If other test type, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Descripción
ensure result is included on laboratory report
Tipo de datos
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])