ID

24157

Description

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

Keywords

Versions (1)
  1. 7/26/17 7/26/17 -
Copyright Holder

GlaxoSmithKline

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July 26, 2017

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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

English

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

1 forms  
Serious Adverse Event (SAE)
Description

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Description

person reporting SAE

Data type

text

Alias
UMLS CUI [1]
C0008961
Serious Adverse Event
Description

serious adverse event

Data type

text

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

onset date and time

Data type

datetime

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

end date and time

Data type

datetime

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

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

Data type

text

Alias
UMLS CUI [1]
C1705586
Event Course
Description

event course

Data type

text

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

intesity

Data type

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.
Description

serious adverse event reason

Data type

text

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

serious adverse event reason

Data type

text

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

action taken

Data type

text

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

SAE abate

Data type

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)?
Description

study medication reintroduced

Data type

boolean

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

SAE recur

Data type

boolean

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

relationship to investigational drug

Data type

text

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

SAE association

Data type

text

Alias
UMLS CUI [1]
C1706737
Please specify:
Description

SAE association

Data type

text

Alias
UMLS CUI [1]
C1706737
Corrective Therapy
Description

If Yes, please record on Concomitant Medication form

Data type

boolean

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

subject withdrawn due to event

Data type

boolean

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

laboratory test

Data type

text

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

laboratory date

Data type

date

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

laboratory value

Data type

text

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

unit

Data type

text

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

normal range

Data type

text

Alias
UMLS CUI [1]
C2826705
Remarks
Description

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

Data type

text

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

randomisation code broken

Data type

boolean

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

randomisation number

Data type

integer

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

investigator

Data type

text

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

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
Description

baseline signs and symptoms

Data type

boolean

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

prior medication

Data type

boolean

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

signatures and dates

Data type

boolean

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

laboratory

Data type

boolean

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

correct, complete recording

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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