ID

26111

Beschreibung

Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female 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 : Parkinson Disease Documentation part: Adverse Event

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Versionen (1)
  1. 09.10.17 09.10.17 -
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GlaxoSmithKline

Hochgeladen am

9. Oktober 2017

DOI

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Dose strength equivalence of ropinirole CR in healthy adults Adverse Event 101468/219

Englisch

Adverse Event Dose strength equivalence of ropinirole CR in healthy adults 101468/219

1 Formulare  
Adverse Event
Beschreibung

Adverse Event

Alias
UMLS CUI-1
C0877248
Adverse Event
Beschreibung

Record any Adverse event (using standard medical terminology) observed or elicited by the following direct question to the subject: "Do you feel different in any way since starting the treatment or since the last visit?" Provide the diagnosis not symptoms where possible.

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Outcome
Beschreibung

Adverse event outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Adverse Event Onset Date
Beschreibung

Adverse Event Onset Date

Datentyp

date

Alias
UMLS CUI [1]
C2985916
Adverse Event Onset Time
Beschreibung

Adverse Event Onset Time

Datentyp

time

Alias
UMLS CUI [1]
C2697889
Adverse Event End Date
Beschreibung

Adverse Event End Date

Datentyp

date

Alias
UMLS CUI [1]
C2697886
Adverse event end time
Beschreibung

Adverse event end time

Datentyp

time

Alias
UMLS CUI [1]
C2826658
Event Course
Beschreibung

adverse event course

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Number of episodes
Beschreibung

If Intermittent = "Yes"

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Beschreibung

Intensity of the adverse event

Datentyp

integer

Alias
UMLS CUI [1]
C1710066
Action Taken with Respect to lnvestigational Drug
Beschreibung

Action Taken in response to event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C0304229
Relationship to lnvestigational Drug
Beschreibung

Relationship to lnvestigational Drug

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Corrective Therapy
Beschreibung

Corrective Therapy. If "Yes", Please record on Concomitant Medication form

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was subject withdrawn due to this AE?
Beschreibung

withdrawn due to event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0877248
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Ähnliche Modelle

Adverse Event Dose strength equivalence of ropinirole CR in healthy adults 101468/219

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Adverse Event
Item
Adverse Event
boolean
C0877248 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Adverse event outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
Adverse Event Onset Date
Item
Adverse Event Onset Date
date
C2985916 (UMLS CUI [1])
Adverse Event Onset Time
Item
Adverse Event Onset Time
time
C2697889 (UMLS CUI [1])
Adverse Event End Date
Item
Adverse Event End Date
date
C2697886 (UMLS CUI [1])
Adverse event end time
Item
Adverse event end time
time
C2826658 (UMLS CUI [1])
Item
Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
adverse event course
Code List
Event Course
CL Item
Intermittent (1)
CL Item
Constant (2)
adverse event number of episodes
Item
Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
Intensity of the adverse event
Code List
Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action Taken with Respect to lnvestigational Drug
integer
C1547656 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Action Taken in response to event
Code List
Action Taken with Respect to lnvestigational Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Drug stopped (5)
Item
Relationship to lnvestigational Drug
integer
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Relationship to lnvestigational Drug
Code List
Relationship to lnvestigational Drug
CL Item
Related (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated  (3)
CL Item
Unrelated (4)
corrective therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
withdrawn due to event
Item
Was subject withdrawn due to this AE?
boolean
C0422727 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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