ID
25718
Beskrivning
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
Nyckelord
Versioner (2)
- 2017-09-12 2017-09-12 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
12 september 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
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
Beskrivning
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beskrivning
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beskrivning
diagnosis or signs/symptoms
Datatyp
text
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0037088
Beskrivning
24 hr - clock
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1717740
Beskrivning
symptom intensity of adverse event
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Beskrivning
If intermittent, record the number of episodes.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beskrivning
adverse event outcome
Datatyp
text
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
24 hr - clock
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1717740
- UMLS CUI [1,2]
- C2699488
Beskrivning
medication change of study drug as result of AE
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0580105
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0877248
Beskrivning
Did the subject withdraw from study as a result of this non-serious AE?
Datatyp
text
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
relationship of adverse event to study drug
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
If Yes, please record on concomitant medication page
Datatyp
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])