ID
36871
Descripción
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.
Palabras clave
Versiones (4)
- 1/9/17 1/9/17 -
- 18/6/19 18/6/19 -
- 18/6/19 18/6/19 -
- 17/9/21 17/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
18 de junio de 2019
DOI
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Licencia
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
Descripción
Significant Medical/ Surgical History And Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1699700
- UMLS CUI [2]
- C0543467
Descripción
Diagnosis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011900
Descripción
Month Year
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C0439234
- UMLS CUI [1,2]
- C0011900
Descripción
Medical condition
Tipo de datos
text
Descripción
Prior Medication
Alias
- UMLS CUI-1
- C2826257
Descripción
If you tick ‘Yes’, please record each medication in the following items.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826257
Descripción
(Trade name preferred)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2360065
Descripción
(eg 500 mg)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1960417
Descripción
(eg BID, PRN)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3476109
Descripción
Other routes may be entered onto the form when appropriate, and will be coded prior to data entry.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013153
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Descripción
(e.g. 6 years)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0444917
Descripción
day month year. If therapy/medication is continuing tick the follwing item.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0806020
Descripción
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.
Tipo de datos
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])