ID

40829

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2020-05-19 2020-05-19 -
  2. 2020-05-20 2020-05-20 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

20 maj 2020

DOI

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Licens

Creative Commons BY-NC 4.0
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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

Engelsk

Significant Medical/ Surgical History; Physical Examination; Pregnancy Test

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Significant Medical/ Surgical History (Period 1 Day -1)
Beskrivning

Significant Medical/ Surgical History (Period 1 Day -1)

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical conditions since screening?
Beskrivning

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.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0543467
Significant Medical/ Surgical History (Period 2 Day -1)
Beskrivning

Significant Medical/ Surgical History (Period 2 Day -1)

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical conditions since treatment period 1?
Beskrivning

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.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0543467
Significant Medical/ Surgical History
Beskrivning

Significant Medical/ Surgical History

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Alias
UMLS CUI [1]
C0011900
Year of first diagnosis
Beskrivning

Year of first diagnosis

Datatyp

partialDate

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Diagnosis status
Beskrivning

Diagnosis status

Datatyp

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0449438
Physical Examination (Period 1 Day -1)
Beskrivning

Physical Examination (Period 1 Day -1)

Alias
UMLS CUI-1
C0031809
Physical Examination - Date
Beskrivning

Physical Examination - Date

Datatyp

date

Alias
UMLS CUI [1]
C2826643
Physical Examination - Time
Beskrivning

Physical Examination - Time

Datatyp

time

Alias
UMLS CUI [1]
C2826761
Has there been any change from the last examination (screening)?
Beskrivning

If Yes, record below. Any clinically relevant worsening since the last exam must be recorded on the Adverse Events page.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0443172
Physical Examination - Change
Beskrivning

Physical Examination - Change

Datatyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0443172
Physical Examination (Period 2 Day -1)
Beskrivning

Physical Examination (Period 2 Day -1)

Alias
UMLS CUI-1
C0031809
Physical Examination - Date
Beskrivning

Physical Examination - Date

Datatyp

date

Alias
UMLS CUI [1]
C2826643
Physical Examination - Time
Beskrivning

Physical Examination - Time

Datatyp

time

Alias
UMLS CUI [1]
C2826761
Has there been any change from the last examination (period 1)?
Beskrivning

If Yes, record below. Any clinically relevant worsening since the last exam must be recorded on the Adverse Events page.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0443172
Physical Examination - Change
Beskrivning

Physical Examination - Change

Datatyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0443172
Physical Examination (Follow-Up)
Beskrivning

Physical Examination (Follow-Up)

Alias
UMLS CUI-1
C0031809
Physical Examination - Date
Beskrivning

Physical Examination - Date

Datatyp

date

Alias
UMLS CUI [1]
C2826643
Physical Examination - Time
Beskrivning

Physical Examination - Time

Datatyp

time

Alias
UMLS CUI [1]
C2826761
Has there been any change from the last examination (Period 1 Day -1)?
Beskrivning

If Yes, record below. Any clinically relevant worsening since the last exam must be recorded on the Adverse Events page.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0443172
Physical Examination - Change
Beskrivning

Physical Examination - Change

Datatyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0443172
Physical Examination - Investigator's Signature
Beskrivning

Physical Examination - Investigator's Signature

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C2346576
Investigator's Signature
Beskrivning

Investigator's Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature Date
Beskrivning

Investigator's Signature Date

Datatyp

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0011008
Pregnancy Test (Females only)
Beskrivning

Pregnancy Test (Females only)

Alias
UMLS CUI-1
C0032976
Was a pregnancy test carried out?
Beskrivning

Was a pregnancy test carried out?

Datatyp

boolean

Alias
UMLS CUI [1]
C0032976
If no pregnancy test has been carried out, please specify reason
Beskrivning

If no pregnancy test has been carried out, please specify reason

Datatyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C2826287
Date and time of pregnancy test
Beskrivning

Date and time of pregnancy test

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Result of pregnancy test
Beskrivning

If ’Positive’, withdraw the subject from the study.

Datatyp

integer

Alias
UMLS CUI [1]
C0427777
Please mark box for test type
Beskrivning

Please mark box for test type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0332307
If other test type, specify
Beskrivning

If other test type, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Laboratory name, if applicable
Beskrivning

ensure result is included on laboratory report

Datatyp

text

Alias
UMLS CUI [1]
C1882331
Tillbaka till toppen

Similar models

Significant Medical/ Surgical History; Physical Examination; Pregnancy Test

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Significant Medical/ Surgical History (Period 1 Day -1)
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical conditions since screening?
Item
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical conditions since screening?
boolean
C0012634 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Item Group
Significant Medical/ Surgical History (Period 2 Day -1)
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical conditions since treatment period 1?
Item
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical conditions since treatment period 1?
boolean
C0012634 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Item Group
Significant Medical/ Surgical History
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis
Item
Year of first diagnosis
partialDate
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Diagnosis status
integer
C0011900 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Diagnosis status
Code List
Diagnosis status
CL Item
Past (1)
CL Item
Ongoing (2)
Item Group
Physical Examination (Period 1 Day -1)
C0031809 (UMLS CUI-1)
Physical Examination - Date
Item
Physical Examination - Date
date
C2826643 (UMLS CUI [1])
Physical Examination - Time
Item
Physical Examination - Time
time
C2826761 (UMLS CUI [1])
Has there been any change from the last examination (screening)?
Item
Has there been any change from the last examination (screening)?
boolean
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Physical Examination - Change
Item
Physical Examination - Change
text
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item Group
Physical Examination (Period 2 Day -1)
C0031809 (UMLS CUI-1)
Physical Examination - Date
Item
Physical Examination - Date
date
C2826643 (UMLS CUI [1])
Physical Examination - Time
Item
Physical Examination - Time
time
C2826761 (UMLS CUI [1])
Has there been any change from the last examination (period 1)?
Item
Has there been any change from the last examination (period 1)?
boolean
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Physical Examination - Change
Item
Physical Examination - Change
text
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item Group
Physical Examination (Follow-Up)
C0031809 (UMLS CUI-1)
Physical Examination - Date
Item
Physical Examination - Date
date
C2826643 (UMLS CUI [1])
Physical Examination - Time
Item
Physical Examination - Time
time
C2826761 (UMLS CUI [1])
Has there been any change from the last examination (Period 1 Day -1)?
Item
Has there been any change from the last examination (Period 1 Day -1)?
boolean
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Physical Examination - Change
Item
Physical Examination - Change
text
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item Group
Physical Examination - Investigator's Signature
C0031809 (UMLS CUI-1)
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
C1519316 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Pregnancy Test (Females only)
C0032976 (UMLS CUI-1)
Was a pregnancy test carried out?
Item
Was a pregnancy test carried out?
boolean
C0032976 (UMLS CUI [1])
If no pregnancy test has been carried out, please specify reason
Item
If no pregnancy test has been carried out, please specify reason
text
C0032976 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Date and time of pregnancy test
Item
Date and time of pregnancy test
datetime
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Result of pregnancy test
integer
C0427777 (UMLS CUI [1])
Result of pregnancy test
Code List
Result of pregnancy test
CL Item
Positive (1)
CL Item
Negative (2)
Item
Please mark box for test type
integer
C0032976 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Please mark box for test type
Code List
Please mark box for test type
CL Item
Dipstick urine HCG (1)
CL Item
Serum HCG (2)
CL Item
Other, please specify (3)
If other test type, specify
Item
If other test type, specify
text
C0032976 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Laboratory name, if applicable
Item
Laboratory name, if applicable
text
C1882331 (UMLS CUI [1])
Tillbaka till toppen 

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