ID
36871
Beschrijving
Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome This document contains the Significant Medical/ Surgical History And Physical Examination and the Prior Medication form. It has to be filled in for screening.
Trefwoorden
Versies (4)
- 01-09-17 01-09-17 -
- 18-06-19 18-06-19 -
- 18-06-19 18-06-19 -
- 17-09-21 17-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
18 juni 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201
Significant Medical/ Surgical History And Physical Examination, Prior Medication
Beschrijving
Significant Medical/ Surgical History And Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Beschrijving
If you tick Yes, fill in the follwoing items for each diagnosis. Only in the absence of a diagnosis, record the signs and symptoms on separate lines.
Datatype
text
Alias
- UMLS CUI [1]
- C1699700
- UMLS CUI [2]
- C0543467
Beschrijving
Diagnosis
Datatype
text
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
Month Year
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0439234
- UMLS CUI [1,2]
- C0011900
Beschrijving
Medical condition
Datatype
text
Beschrijving
Prior Medication
Alias
- UMLS CUI-1
- C2826257
Beschrijving
If you tick ‘Yes’, please record each medication in the following items.
Datatype
text
Alias
- UMLS CUI [1]
- C2826257
Beschrijving
(Trade name preferred)
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
(eg 500 mg)
Datatype
text
Alias
- UMLS CUI [1]
- C1960417
Beschrijving
(eg BID, PRN)
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Other routes may be entered onto the form when appropriate, and will be coded prior to data entry.
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Indication on Prior Medication page must correlate utilizing the same terminology. Indication on Concomitant page must be recorded on the Adverse Events Page and expressed utilizing the same terminology.
Datatype
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschrijving
(e.g. 6 years)
Datatype
text
Alias
- UMLS CUI [1]
- C0444917
Beschrijving
day month year. If therapy/medication is continuing tick the follwing item.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0806020
Beschrijving
If a medication was marked continuing at the initial visit (on the Prior and Concomitant Medication Page), but has since had a dosage change or has been stopped, it must be recorded on this form as a change with the start and end date.
Datatype
text
Alias
- UMLS CUI [1]
- C1553904
Similar models
Significant Medical/ Surgical History And Physical Examination, Prior Medication
C0031809 (UMLS CUI-2)
C0543467 (UMLS CUI [2])
C0011900 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])