ID

24574

Beschreibung

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: Follow-Up Serious Adverse Event, Form D, Investigator Comment Log, Investigator's Statement

Stichworte

Versionen (1)
  1. 06.08.17 06.08.17 -
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GlaxoSmithKline

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6. August 2017

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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Serious Adverse Event, Form D, Investigator Comment Log, Investigator's Statement

Englisch

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Serious Adverse Event, Form D, Investigator Comment Log, Investigator's Statement

1 Formulare  
Serious Adverse Event (SAE)
Beschreibung

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Beschreibung

person reporting sae

Datentyp

text

Alias
UMLS CUI [1]
C0008961
Serious Adverse Event
Beschreibung

serious adverse event

Datentyp

text

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

serious adverse event onset

Datentyp

datetime

Alias
UMLS CUI [1]
C2826806
End Date and Time
Beschreibung

serious adverse event end

Datentyp

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Event Course
Beschreibung

serious adverse event course

Datentyp

text

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

serious adverse event episodes

Datentyp

integer

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

serious adverse event intensity

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
Specify reason(s) for considering this a serious AE. Mark all that apply.
Beschreibung

serious adverse event reason

Datentyp

text

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

serious adverse event reason

Datentyp

text

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

action taken

Datentyp

text

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

SAE abate

Datentyp

boolean

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

study medication reintroduced

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0580673
If yes, did SAE recur?
Beschreibung

SAE recur

Datentyp

boolean

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

relationship to investigational drug

Datentyp

text

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

SAE association

Datentyp

text

Alias
UMLS CUI [1]
C1706737
Please specify:
Beschreibung

SAE association

Datentyp

text

Alias
UMLS CUI [1]
C1706737
Corrective Therapy
Beschreibung

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

subject withdrawn due to adverse event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0877248
Remarks
Beschreibung

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

Datentyp

text

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

randomisation code broken

Datentyp

boolean

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

randomisation number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Relevant Laboratory Data
Beschreibung

Relevant Laboratory Data

Alias
UMLS CUI-1
C0022885
Test
Beschreibung

laboratory test

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Date
Beschreibung

laboratory date

Datentyp

date

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0011008
Value
Beschreibung

laboratory value

Datentyp

text

Alias
UMLS CUI [1]
C0022877
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Normal Range
Beschreibung

normal range

Datentyp

text

Alias
UMLS CUI [1]
C0086715
Form D
Beschreibung

Form D

Alias
UMLS CUI-1
C1306577
Certified Cause of Death
Beschreibung

cause of death

Datentyp

text

Alias
UMLS CUI [1]
C0007465
Date of Death
Beschreibung

date of death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Was an autopsy done?
Beschreibung

autopsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0004398
If YES, please summarize findings (include diagnosis):
Beschreibung

autopsy

Datentyp

text

Alias
UMLS CUI [1]
C0004398
Investigator Comment LOG
Beschreibung

Investigator Comment LOG

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
Date of comment
Beschreibung

date of comment

Datentyp

date

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0011008
CRF page number if applicable
Beschreibung

page number

Datentyp

integer

Alias
UMLS CUI [1]
C1704732
Comment
Beschreibung

comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Investigator's Checklist
Beschreibung

Investigator's Checklist

Alias
UMLS CUI-1
C1707357
UMLS CUI-2
C0008961
Check all Adverse Event forms are up to date and complete
Beschreibung

adverse event forms completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C0205197
Check that the Concomitant Medication form is up to date
Beschreibung

concomitant medication form up to date

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C0237400
Check that all appropriate pages are signed (thus indicating completition) an dated
Beschreibung

signing

Datentyp

boolean

Alias
UMLS CUI [1]
C1519316
Check that laboratory results are included
Beschreibung

laboratory results included

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0920316
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Ähnliche Modelle

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Serious Adverse Event, Form D, Investigator Comment Log, Investigator's Statement

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
serious adverse event onset
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
serious adverse event end
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
serious adverse event outcome
Code List
Outcome
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
CL Item
Died (Died)
Item
Event Course
text
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
serious adverse event course
Code List
Event Course
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
serious adverse event episodes
Item
Number of episodes
integer
C1519255 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
serious adverse event intensity
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 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
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (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
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
subject withdrawn due to adverse event
Item
Was subject withdrawn due to this AE?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
SAE 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])
Item Group
Relevant Laboratory Data
C0022885 (UMLS CUI-1)
laboratory test
Item
Test
text
C0022885 (UMLS CUI [1])
laboratory date
Item
Date
date
C0022877 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
laboratory value
Item
Value
text
C0022877 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
normal range
Item
Normal Range
text
C0086715 (UMLS CUI [1])
Item Group
Form D
C1306577 (UMLS CUI-1)
cause of death
Item
Certified Cause of Death
text
C0007465 (UMLS CUI [1])
date of death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
autopsy
Item
Was an autopsy done?
boolean
C0004398 (UMLS CUI [1])
autopsy
Item
If YES, please summarize findings (include diagnosis):
text
C0004398 (UMLS CUI [1])
Item Group
Investigator Comment LOG
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
date of comment
Item
Date of comment
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
page number
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1])
comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's Checklist
C1707357 (UMLS CUI-1)
C0008961 (UMLS CUI-2)
adverse event forms completed
Item
Check all Adverse Event forms are up to date and complete
boolean
C0877248 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
concomitant medication form up to date
Item
Check that the Concomitant Medication form is up to date
boolean
C2347852 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])
signing
Item
Check that all appropriate pages are signed (thus indicating completition) an dated
boolean
C1519316 (UMLS CUI [1])
laboratory results included
Item
Check that laboratory results are included
boolean
C1254595 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
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