ID

24780

Descrição

Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Parkinson Disease Documentation part: Follow-up Visit

Palavras-chave

17/08/2017 17/08/2017 -

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17 de agosto de 2017

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Creative Commons BY-NC 3.0

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Dose strength equivalence of ropinirole CR in healthy adults Follow-up Visit 101468/219

model
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Follow-up Visit Dose strength equivalence of ropinirole CR in healthy adults 101468/219

1 Formulários

StudyEvent: ODM
1. Follow-up Visit Dose strength equivalence of ropinirole CR in healthy adults 101468/219

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Physical Examination

Item Group

Physical Examination

C0031809 (UMLS CUI-1)

physical examination

Item

Have any changes been noted compared to the examination conducted at screening?

boolean

C0031809 (UMLS CUI [1])

Pregnancy Test

Item Group

Pregnancy Test

C0032976 (UMLS CUI-1)
C0032961 (UMLS CUI-2)

pregnancy test

Item

Was a pregnancy test carried out?

boolean

C0032976 (UMLS CUI [1])

reason pregnancy test not done

Item

Was a pregnancy test carried out? If No, please specify reason

text

C0032976 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])

Date of pregnancy test

Item

Date of pregnancy test

date

C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Pregnancy test result

Item

Pregnancy test result

integer

C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

Pregnancy test result

Code List

Pregnancy test result

CL Item

Positive (1)

CL Item

Negative (2)

ECG Monitoring

Item Group

ECG Monitoring

C1623258 (UMLS CUI-1)

Date ECG

Item

Date ECG

date

C1623258 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Time ECG

Item

Time ECG

time

C1623258 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

Heart rate

Item

Heart rate

integer

C0018810 (UMLS CUI [1])

Item

float

C1880446 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])

QRS

Item

QRS

float

C1880451 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])

QTC

Item

QTC

float

C0860814 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])

ECG clinically significant

Item

ECG clinically significant?

boolean

C1623258 (UMLS CUI [1])

Comments

Item

ECG Comments

text

C1623258 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])

Vitals Signs

Item Group

Vitals Signs, Follow-up

C0518766 (UMLS CUI-1)
C1522577 (UMLS CUI-2)

Date

Item

Date of vital sign measurement

date

C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Time

Item

Time of vital sign measurement

time

C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

systolic Blood pressure

Item

Blood pressure - supine, systolic

integer

C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])

diastolic blood pressure

Item

Blood pressure - supine, diastolic

integer

C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])

Heart rate supine

Item

Heart rate - supine

integer

C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])

systolic Blood pressure erect

Item

Blood pressure - erect, systolic

integer

C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])

diastolic Blood pressure erect

Item

Blood pressure - erect, diastolic

integer

C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])

Heart rate erect

Item

Heart rate - erect

integer

C0018810 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])

Clinical Chemistry and Haematology

Item Group

Clinical Chemistry and Haematology

C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)

Date blood sample taken

Item

Date blood sample taken

date

C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Time blood sample taken

Item

Time blood sample taken

time

C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

Clinical Chemistry and Haematology

Item

Clinical Chemistry and Haematology: Are there clinically significant abnormal values?

boolean

C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])

Comments

Item

Comments

text

C0005834 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])

Urinalysis

Item Group

Urinalysis

C0042014 (UMLS CUI-1)
C0200354 (UMLS CUI-2)

Date urine sample taken

Item

Date urine sample taken

date

C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Time urine sample taken

Item

Time urine sample taken

time

C0200354 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

Comments

Item

Urinalysis Comments

text

C0042014 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])

Urinalysis

Item

Urinalysis: Are there clinically significant abnormal values?

boolean

C0042014 (UMLS CUI [1])

Item

PH Result

float

C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])

Item

PH Clinically significant?

boolean

C0042044 (UMLS CUI [1])
C0042014 (UMLS CUI [2])

Comments

Item

PH Comments

text

C0042044 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])

Protein

Item

Protein Result

float

C0262923 (UMLS CUI [1])
C0042014 (UMLS CUI [2])

Protein

Item

Protein clinically significant?

boolean

C0262923 (UMLS CUI [1])
C0042014 (UMLS CUI [2])

Comments

Item

Protein Comments

text

C0262923 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])

Glucose

Item

Glucose Result

float

C0004076 (UMLS CUI [1])
C0042014 (UMLS CUI [2])

Glucose

Item

Glucose Clinically Significant?

boolean

C0004076 (UMLS CUI [1])
C0042014 (UMLS CUI [2])

Comments

Item

Glucose Comments

text

C0004076 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])

Bilirubin

Item

Bilirubin Result

float

C0344395 (UMLS CUI [1])
C0042014 (UMLS CUI [2])

Bilirubin

Item

Bilirubin Clinically Significant?

boolean

C0344395 (UMLS CUI [1])
C0042014 (UMLS CUI [2])

Comments

Item

Bilirubin Comments

text

C0344395 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])

Blood

Item

Blood Result

text

C0018965 (UMLS CUI [1])
C0042014 (UMLS CUI [2])

Blood

Item

Blood Clinically Significant?

boolean

C0018965 (UMLS CUI [1])
C0042014 (UMLS CUI [2])

Comments

Item

Blood Comments

text

C0018965 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])

Adverse Event

Item Group

Adverse Event

C0877248 (UMLS CUI-1)

Time Point

Item

Time Point

integer

C0877248 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])

Time Point

Code List

Time Point

CL Item

Pre-dose (1)

CL Item

+1 hrs (2)

CL Item

+4 hrs (3)

CL Item

+6 hrs (4)

CL Item

+12 hrs (5)

CL Item

+24 hrs (6)

CL Item

+36 hrs (7)

Adverse Event

Item

Any Adverse Event?

boolean

C0877248 (UMLS CUI [1])

Pregnancy Information

Item Group

Pregnancy Information

C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)

pregnant

Item

Did the patient become pregnant during the study?

integer

C0032961 (UMLS CUI [1])

pregnant

Code List

Did the patient become pregnant during the study?

CL Item

Not applicable (not of childbearing potential or male) (1)

CL Item

No (2)

CL Item

Yes (If ’Yes’ record details on Pregnancy Notification Form) (3)

Study Conclusion

Item Group

Study Conclusion

C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C2349954 (UMLS CUI-3)

complete study

Item

Did the subject complete the study as planned?

boolean

C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])

reason for discontinuation

Item

Did the subject complete the study as planned? If ’NO’, mark the one most appropriate category

integer

C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])

reason for discontinuation

Code List

Did the subject complete the study as planned? If ’NO’, mark the one most appropriate category

CL Item

Adverse Event (complete Adverse Event Form) (1)

CL Item

Insufficient therapeutic effect (2)

CL Item

Deviation from Protocol (including non-compliance) (3)

CL Item

Lost to Follow-Up (4)

CL Item

Other (5)

reason for discontinuation

Item

Reason for discontinuation, if other please specify

text

C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])

Comments withdrawal

Item

Comments on reason for withdrawal

text

C2349954 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])

Date of Withdrawal

Item

Date of Withdrawal

date

C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Time of Withdrawal

Item

Time of Withdrawal

time

C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

Date of Final Dose

Item

Date of Final Dose

date

C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Time of Final Dose

Item

Time of Final Dose

time

C0013227 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])

Follow up comments

Item

Follow up general comments

text

C1522577 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])

Investigators Statement

Item Group

Investigators Statement

C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)

Patient Number

Item

Patient Number

text

C2348585 (UMLS CUI [1])

Center Number

Item

Center Number

text

C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])

Adverse Event forms

Item

Check all Adverse Event forms are up to date and complete

integer

C1283174 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])

Adverse Event forms

Code List

Check all Adverse Event forms are up to date and complete

CL Item

done (1)

CL Item

not done (2)

Concomitant Medication form

Item

Check that the Concomitant Medication form is up to date

integer

C1283174 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])

Adverse Event forms

Code List

Check that the Concomitant Medication form is up to date

CL Item

done (1)

CL Item

not done (2)

pages are signed

Item

Check that all appropriate pages are signed (thus indicating completion) and dated

integer

C1283174 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])

Adverse Event forms

Code List

Check that all appropriate pages are signed (thus indicating completion) and dated

CL Item

done (1)

CL Item

not done (2)

laboratory results

Item

Check that laboratory results are included

integer

C1283174 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])

Adverse Event forms

Code List

Check that laboratory results are included

CL Item

done (1)

CL Item

not done (2)

Investigators signature

Item

I certify that the observtions and findings are recorded correctly and completely in this CRF. Investigators signature

text

C2346576 (UMLS CUI [1])

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Dose strength equivalence of ropinirole CR in healthy adults Follow-up Visit 101468/219

Follow-up Visit Dose strength equivalence of ropinirole CR in healthy adults 101468/219

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