ID

24157

Descrição

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Serious Adverse Event, Investigator's Statement

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Versões (1)
  1. 26/07/2017 26/07/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

26 de julho de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Serious Adverse Event (SAE), Investigator's Statement

Inglês

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Serious Adverse Event (SAE), Investigator's Statement

1 Formulários  
Serious Adverse Event (SAE)
Descrição

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Descrição

person reporting SAE

Tipo de dados

text

Alias
UMLS CUI [1]
C0008961
Serious Adverse Event
Descrição

serious adverse event

Tipo de dados

text

Alias
UMLS CUI [1]
C1519255
Onset Date and Time
Descrição

onset date and time

Tipo de dados

datetime

Alias
UMLS CUI [1]
C2985916
End Date and Time (If ongoing please leave blank)
Descrição

end date and time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C2981425
UMLS CUI [1,2]
C1442488
Outcome
Descrição

If yubject died, please inform GSK within 24 hours and complete Form D.

Tipo de dados

text

Alias
UMLS CUI [1]
C1705586
Event Course
Descrição

event course

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Intensity (maximum)
Descrição

intesity

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0522510
UMLS CUI [1,2]
C0877248
Specify reason(s) for considering this a serious AE. Mark all that apply.
Descrição

serious adverse event reason

Tipo de dados

text

Alias
UMLS CUI [1]
C3828190
Please specify other:
Descrição

serious adverse event reason

Tipo de dados

text

Alias
UMLS CUI [1]
C3828190
Action Taken with Respect to Investigational Drug
Descrição

action taken

Tipo de dados

text

Alias
UMLS CUI [1]
C2826626
Did the SAE abate?
Descrição

SAE abate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3853704
If the study medication was interrupted, stopped or dose reduced: Was study medication reintroduced or dose increased)?
Descrição

study medication reintroduced

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0580673
If Yes, did SAE recur?
Descrição

SAE recur

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
Relationship to Investigational Drug
Descrição

relationship to investigational drug

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C1519255
The SAE is probably associated with:
Descrição

SAE association

Tipo de dados

text

Alias
UMLS CUI [1]
C1706737
Please specify:
Descrição

SAE association

Tipo de dados

text

Alias
UMLS CUI [1]
C1706737
Corrective Therapy
Descrição

If Yes, please record on Concomitant Medication form

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0087111
Was subject withdrawn due to this AE?
Descrição

subject withdrawn due to event

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0877248
Laboratory Data: Test
Descrição

laboratory test

Tipo de dados

text

Alias
UMLS CUI [1]
C0022885
Laboratory Data: Date
Descrição

laboratory date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0011008
Laboratory Data: Value
Descrição

laboratory value

Tipo de dados

text

Alias
UMLS CUI [1]
C0022877
Laboratory Data: Units
Descrição

unit

Tipo de dados

text

Alias
UMLS CUI [1]
C1519795
Laboratory Data: Normal Range
Descrição

normal range

Tipo de dados

text

Alias
UMLS CUI [1]
C2826705
Remarks
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
If applicable, was randomisation code broken at investigational site?
Descrição

randomisation code broken

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0034656
Randomisation/ Study Medication Number
Descrição

randomisation number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Investigator
Descrição

investigator

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
Investigator's Checklist
Descrição

Investigator's Checklist

Alias
UMLS CUI-1
C1707357
UMLS CUI-2
C0008961
Check all Baseline Signs and Symptoms form is up to date and complete
Descrição

baseline signs and symptoms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0037088
Check that the Prior Medication form is up to date
Descrição

prior medication

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013227
Check that all appropriate pages are sgined (thus indicating completition) and dated
Descrição

signatures and dates

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2346576
UMLS CUI [2]
C0011008
Check that laboratory results are included
Descrição

laboratory

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022877
I certify that the observations and findings are recorded correctly and completely in this CRF.
Descrição

correct, complete recording

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0034869
UMLS CUI [1,2]
C2349182
UMLS CUI [1,3]
C0205197
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Similar models

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Serious Adverse Event (SAE), Investigator's Statement

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Serious Adverse Event (SAE)
C1519255 (UMLS CUI-1)
person reporting SAE
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1])
serious adverse event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
onset date and time
Item
Onset Date and Time
datetime
C2985916 (UMLS CUI [1])
end date and time
Item
End Date and Time (If ongoing please leave blank)
datetime
C2981425 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item
Outcome
text
C1705586 (UMLS CUI [1])
outcome
Code List
Outcome
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
CL Item
Died (Died)
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
event course
Code List
Event Course
CL Item
Intermittent (Intermittent)
CL Item
Consistant (Consistant)
Item
Intensity (maximum)
text
C0522510 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
intesity
Code List
Intensity (maximum)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Specify reason(s) for considering this a serious AE. Mark all that apply.
text
C3828190 (UMLS CUI [1])
serious adverse event reason
Code List
Specify reason(s) for considering this a serious AE. Mark all that apply.
CL Item
results in Death (A)
CL Item
life threatening (B)
CL Item
requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
results in disability/incapacity (D)
CL Item
congenital anomaly/birth defect (E)
CL Item
other (see definition= (F)
serious adverse event reason
Item
Please specify other:
text
C3828190 (UMLS CUI [1])
Item
Action Taken with Respect to Investigational Drug
text
C2826626 (UMLS CUI [1])
action taken
Code List
Action Taken with Respect to Investigational Drug
CL Item
None (None)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Drug interrupted/restarted (Drug interrupted/restarted)
CL Item
Drug stopped (Drug stopped)
SAE abate
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
study medication reintroduced
Item
If the study medication was interrupted, stopped or dose reduced: Was study medication reintroduced or dose increased)?
boolean
C0013230 (UMLS CUI [1,1])
C0580673 (UMLS CUI [1,2])
SAE recur
Item
If Yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Item
Relationship to Investigational Drug
text
C0013230 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
relationship to investigational drug
Code List
Relationship to Investigational Drug
CL Item
Not related (Not related)
CL Item
Unlikely (Unlikely)
CL Item
Suspected (reasonable possibility) (Suspected (reasonable possibility))
CL Item
Probable (Probable)
Item
The SAE is probably associated with:
text
C1706737 (UMLS CUI [1])
SAE association
Code List
The SAE is probably associated with:
CL Item
Protocol design or procedures (but not to study drug) (Protocol design or procedures (but not to study drug))
CL Item
Another condition (e.g. condition under study, intercurrent illness) (Another condition (e.g. condition under study, intercurrent illness))
CL Item
Another drug (Another drug)
SAE association
Item
Please specify:
text
C1706737 (UMLS CUI [1])
corrective therapy
Item
Corrective Therapy
boolean
C0559546 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
subject withdrawn due to event
Item
Was subject withdrawn due to this AE?
boolean
C0422727 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
laboratory test
Item
Laboratory Data: Test
text
C0022885 (UMLS CUI [1])
laboratory date
Item
Laboratory Data: Date
date
C0022877 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
laboratory value
Item
Laboratory Data: Value
text
C0022877 (UMLS CUI [1])
unit
Item
Laboratory Data: Units
text
C1519795 (UMLS CUI [1])
normal range
Item
Laboratory Data: Normal Range
text
C2826705 (UMLS CUI [1])
serious adverse event remarks
Item
Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
randomisation code broken
Item
If applicable, was randomisation code broken at investigational site?
boolean
C0034656 (UMLS CUI [1])
randomisation number
Item
Randomisation/ Study Medication Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Item Group
Investigator's Checklist
C1707357 (UMLS CUI-1)
C0008961 (UMLS CUI-2)
baseline signs and symptoms
Item
Check all Baseline Signs and Symptoms form is up to date and complete
boolean
C0037088 (UMLS CUI [1])
prior medication
Item
Check that the Prior Medication form is up to date
boolean
C0013227 (UMLS CUI [1])
signatures and dates
Item
Check that all appropriate pages are sgined (thus indicating completition) and dated
boolean
C2346576 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
laboratory
Item
Check that laboratory results are included
boolean
C0022877 (UMLS CUI [1])
correct, complete recording
Item
I certify that the observations and findings are recorded correctly and completely in this CRF.
text
C0034869 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
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