ID
25718
Descripción
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
Palabras clave
Versiones (2)
- 12/9/17 12/9/17 -
- 20/9/21 20/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
12 de septiembre de 2017
DOI
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Licencia
Creative Commons BY-NC 3.0
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adverse events PK and tolerability of ropinirole as 5 new formulations 101468/197
adverse events PK and tolerability of ropinirole as 5 new formulations 101468/197
Descripción
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Descripción
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Descripción
diagnosis or signs/symptoms
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0037088
Descripción
24 hr - clock
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1717740
Descripción
symptom intensity of adverse event
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Descripción
If intermittent, record the number of episodes.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Descripción
adverse event outcome
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1705586
Descripción
24 hr - clock
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C1717740
- UMLS CUI [1,2]
- C2699488
Descripción
medication change of study drug as result of AE
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0580105
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0877248
Descripción
Did the subject withdraw from study as a result of this non-serious AE?
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0422727
Descripción
relationship of adverse event to study drug
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Descripción
If Yes, please record on concomitant medication page
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Similar models
adverse events PK and tolerability of ropinirole as 5 new formulations 101468/197
C0037088 (UMLS CUI [2])
C0877248 (UMLS CUI [1,2])
C1717740 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C2699488 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])