visit screening, 1, 2, 3, 4 & final examination pregnancy PK and tolerability of ropinirole as 5 new formulations 101468/197

ID

25474

Beschreibung

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy 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 : Restless Legs Syndrome

Stichworte

Neurologie

Klinische Studie [Dokumenttyp]

Schwangerschaftstests

Restless-legs-Syndrom

Hochgeladen am

4. September 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0

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1 Formulare

StudyEvent: ODM
1. visit screening, 1, 2, 3, 4 & final examination pregnancy PK and tolerability of ropinirole as 5 new formulations 101468/197

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

administrative data

Item Group

Administrative Data

C1320722 (UMLS CUI-1)

focus panel

Item

Focus Panel ID

integer

patient number

Item

Patient No

integer

C1830427 (UMLS CUI [1])

date

Item

Date

date

C0011008 (UMLS CUI [1])

visit number

Item

Number of Visit

text

C1549755 (UMLS CUI [1])

visit number

Code List

Number of Visit

CL Item

Screening (Screening)

CL Item

Period 1/ Day -1 (Period 1/ Day -1)

CL Item

Period 2/ Day -1 (Period 2/ Day -1)

CL Item

Period 3/ Day -1 (Period 3/ Day -1)

CL Item

Period 4/ Day -1 (Period 4/ Day -1)

CL Item

Final Examination (Final Examination)

treatment

Item

Treatment

text

C0087111 (UMLS CUI [1])

initials

Item

Initials

text

C2986440 (UMLS CUI [1])

serum pregnancy test

Item Group

SERUM PREGNANCY TEST

C0430060 (UMLS CUI-1)

pregnancy test

Item

Was a pregnancy test performed?

text

C0032976 (UMLS CUI [1])

pregnancy test

Code List

Was a pregnancy test performed?

CL Item

Yes (Yes)

CL Item

No (No)

time of pregnancy test

Item

Time

time

C0040223 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])

pregnancy test not done

Item

If "no" above, please specify reason

text

C0032976 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])

pregnancy test not done

Code List

If "no" above, please specify reason

CL Item

male (male)

CL Item

other (other)

pregnancy test result

Item

The pregnancy test result was?

text

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

pregnancy test result

Code List

The pregnancy test result was?

CL Item

Positive (Positive)

CL Item

Negative (Negative)

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visit screening, 1, 2, 3, 4 & final examination pregnancy PK and tolerability of ropinirole as 5 new formulations 101468/197