ID

26112

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: Serious Adverse Event

Stichworte

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  1. 09.10.17 09.10.17 -
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GlaxoSmithKline

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9. Oktober 2017

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

Englisch

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

1 Formulare  
Serious Adverse Event
Beschreibung

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Patient Number
Beschreibung

Patient Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Center Number
Beschreibung

Center Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Person Reporting SAE
Beschreibung

Person Reporting SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1519255
Serious Adverse Event
Beschreibung

Serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event
Beschreibung

Specify reason(s) for considering this a serious AE. Mark all that apply.

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event
Beschreibung

Specify reason(s) for considering this a serious AE. If Other, please specify.

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Outcome
Beschreibung

*If subject died, please inform GSK within 24 hours and complete Form D

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Adverse Event Onset Date
Beschreibung

Adverse Event Onset Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C1519255
Adverse Event Onset Time
Beschreibung

Adverse Event Onset Time

Datentyp

time

Alias
UMLS CUI [1,1]
C2697889
UMLS CUI [1,2]
C1519255
Adverse Event End Date
Beschreibung

Adverse Event End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2697886
UMLS CUI [1,2]
C1519255
Adverse event end time
Beschreibung

Adverse event end time

Datentyp

time

Alias
UMLS CUI [1,1]
C2826658
UMLS CUI [1,2]
C1519255
Event Course
Beschreibung

adverse event course

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0750729
Number of episodes
Beschreibung

If Intermittent = "Yes"

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Beschreibung

Intensity of the adverse event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710066
UMLS CUI [1,2]
C1519255
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
UMLS CUI [2]
C1519255
Relationship to lnvestigational Drug
Beschreibung

Relationship to lnvestigational Drug

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
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]
C1519255
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]
C1519255
Did the SAE abate?
Beschreibung

SAE abate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0547047
Was study medication reintroduced (or dose increased)?
Beschreibung

If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?

Datentyp

boolean

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C1519255
If yes, did SAE recur?
Beschreibung

If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
Is the SAE is probably associated with: Protocol design or procedures (but not to study drug)
Beschreibung

SAE associated with protocol procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0087111
If Yes, please specify
Beschreibung

Is the SAE is probably associated with: Protocol design or procedures (but not to study drug)

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0087111
Is the SAE is probably associated with: Another condition (eg, condition under study, intercurrent illness)
Beschreibung

SAE associated with other condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0012634
If Yes, please specify
Beschreibung

Is the SAE is probably associated with: Another condition (eg, condition under study, intercurrent illness)

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0012634
Is the SAE is probably associated with: Another drug
Beschreibung

SAE associated with other drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013227
If Yes, please specify
Beschreibung

Is the SAE is probably associated with: Another drug

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013227
Remarks
Beschreibung

(Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary)

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Relevant Laboratory Data
Beschreibung

Relevant Laboratory Data

Alias
UMLS CUI-1
C0587081
UMLS CUI-2
C1519255
Test
Beschreibung

Test

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Value
Beschreibung

Value

Datentyp

text

Alias
UMLS CUI [1]
C0587081
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Normal Range
Beschreibung

Normal Range

Datentyp

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0587081
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Ähnliche Modelle

Serious 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
Serious Adverse Event
C1519255 (UMLS CUI-1)
Patient Number
Item
Patient Number
integer
C2348585 (UMLS CUI [1])
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Person Reporting SAE
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event
boolean
C1519255 (UMLS CUI [1])
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event
Code List
Serious Adverse Event
CL Item
results in Death (A)
CL Item
life threatening (B)
CL Item
requires hospitalisation or prolongationof existing hospitalization (C)
CL Item
results in disability/incapacity (D)
CL Item
congenital anomaly/birth defect (E)
CL Item
other (see definition) (F)
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Adverse event outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Adverse Event Onset Date
Item
Adverse Event Onset Date
date
C2985916 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Adverse Event Onset Time
Item
Adverse Event Onset Time
time
C2697889 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Adverse Event End Date
Item
Adverse Event End Date
date
C2697886 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Adverse event end time
Item
Adverse event end time
time
C2826658 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Event Course
integer
C1519255 (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
C1519255 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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])
C1519255 (UMLS CUI [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
C1519255 (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
C1519255 (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])
C1519255 (UMLS CUI [1,2])
SAE abate
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
study medication reintroduced
Item
Was study medication reintroduced (or dose increased)?
boolean
C0304229 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
SAE recur
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
SAE associated with protocol procedures
Item
Is the SAE is probably associated with: Protocol design or procedures (but not to study drug)
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
SAE associated with protocol procedures
Item
If Yes, please specify
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
SAE associated with other condition
Item
Is the SAE is probably associated with: Another condition (eg, condition under study, intercurrent illness)
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
SAE associated with other condition
Item
If Yes, please specify
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
SAE associated with other drug
Item
Is the SAE is probably associated with: Another drug
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
SAE associated with other drug
Item
If Yes, please specify
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Remarks
Item
Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Relevant Laboratory Data
C0587081 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Test
Item
Test
text
C0022885 (UMLS CUI [1])
Date
Item
Date
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Value
Item
Value
text
C0587081 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Normal Range
Item
Normal Range
text
C0086715 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
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