ID

40829

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 (2)
  1. 19.05.20 19.05.20 -
  2. 20.05.20 20.05.20 -
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GlaxoSmithKline

Hochgeladen am

20. Mai 2020

DOI

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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

Englisch

Significant Medical/ Surgical History; Physical Examination; Pregnancy Test

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

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

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?
Beschreibung

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.

Datentyp

boolean

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

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?
Beschreibung

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.

Datentyp

boolean

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

Significant Medical/ Surgical History

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

Diagnosis

Datentyp

text

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

Year of first diagnosis

Datentyp

partialDate

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

Diagnosis status

Datentyp

integer

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

Physical Examination (Period 1 Day -1)

Alias
UMLS CUI-1
C0031809
Physical Examination - Date
Beschreibung

Physical Examination - Date

Datentyp

date

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

Physical Examination - Time

Datentyp

time

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

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

Datentyp

boolean

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

Physical Examination - Change

Datentyp

text

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

Physical Examination (Period 2 Day -1)

Alias
UMLS CUI-1
C0031809
Physical Examination - Date
Beschreibung

Physical Examination - Date

Datentyp

date

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

Physical Examination - Time

Datentyp

time

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

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

Datentyp

boolean

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

Physical Examination - Change

Datentyp

text

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

Physical Examination (Follow-Up)

Alias
UMLS CUI-1
C0031809
Physical Examination - Date
Beschreibung

Physical Examination - Date

Datentyp

date

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

Physical Examination - Time

Datentyp

time

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

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

Datentyp

boolean

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

Physical Examination - Change

Datentyp

text

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

Physical Examination - Investigator's Signature

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

Investigator's Signature

Datentyp

text

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

Investigator's Signature Date

Datentyp

date

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

Pregnancy Test (Females only)

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

Was a pregnancy test carried out?

Datentyp

boolean

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

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

Datentyp

text

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

Date and time of pregnancy test

Datentyp

datetime

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

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

Datentyp

integer

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

Please mark box for test type

Datentyp

integer

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

If other test type, specify

Datentyp

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
Beschreibung

ensure result is included on laboratory report

Datentyp

text

Alias
UMLS CUI [1]
C1882331
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Ähnliche Modelle

Significant Medical/ Surgical History; Physical Examination; Pregnancy Test

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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