ID

24558

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: Follow-Up Concomitant Medication, Adverse Event

Keywords

Versions (1)
  1. 8/6/17 8/6/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 6, 2017

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License

Creative Commons BY-NC 3.0
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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Concomitant Medication, Adverse Event

English

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Concomitant Medication, Adverse Event

1 forms  
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Are there any concomitant medication CHANGES since the start of the study?
Description

If YES, please record all medications used below. Where appropriate, medical conditions should be recorded on the Adverse Events Form, utilizing the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0443172
Drug Name (Trade Name Preferred)
Description

drug name

Data type

text

Alias
UMLS CUI [1]
C0013227
Single Dose Unit (e.g. 500 mg)
Description

dose unit

Data type

text

Alias
UMLS CUI [1]
C2826646
Frequency of this Dose (e.g. BID, PRN)
Description

dose frequency

Data type

text

Alias
UMLS CUI [1]
C2826654
Route
Description

route

Data type

text

Alias
UMLS CUI [1]
C0013153
Indication
Description

medication indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Start Date/Time
Description

medication start

Data type

datetime

Alias
UMLS CUI [1]
C0451613
End Date/Time
Description

medication end

Data type

datetime

Alias
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0806020
Continuing at end of Study?
Description

medication ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Adverse Event
Description

adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
Onset Date/Time
Description

adverse event onset

Data type

datetime

Alias
UMLS CUI [1]
C2985916
End Date/Time
Description

(If ongoing, please leave blank)

Data type

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Description

adverse event outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
Event Course
Description

adverse event course

Data type

text

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

adverse event episodes

Data type

integer

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

adverse event intensity

Data type

text

Alias
UMLS CUI [1]
C1710066
Action Taken with Respect to Investigational Drug
Description

action taken

Data type

text

Alias
UMLS CUI [1]
C2826626
Relationship to Investigational Drug
Description

relationship to investigational drug

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Corrective Therapy
Description

If YES, please record on Concomitant Medication form.

Data type

boolean

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

subject withdrawn due to adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0877248
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Similar models

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Concomitant Medication, Adverse Event

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
concomitant medication changes
Item
Are there any concomitant medication CHANGES since the start of the study?
boolean
C2347852 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
drug name
Item
Drug Name (Trade Name Preferred)
text
C0013227 (UMLS CUI [1])
dose unit
Item
Single Dose Unit (e.g. 500 mg)
text
C2826646 (UMLS CUI [1])
dose frequency
Item
Frequency of this Dose (e.g. BID, PRN)
text
C2826654 (UMLS CUI [1])
route
Item
Route
text
C0013153 (UMLS CUI [1])
medication indication
Item
Indication
text
C3146298 (UMLS CUI [1])
medication start
Item
Start Date/Time
datetime
C0451613 (UMLS CUI [1])
medication end
Item
End Date/Time
datetime
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
medication ongoing
Item
Continuing at end of Study?
boolean
C2826666 (UMLS CUI [1])
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
adverse event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
adverse event onset
Item
Onset Date/Time
datetime
C2985916 (UMLS CUI [1])
adverse event end
Item
End Date/Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
adverse event outcome
Code List
Outcome
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
adverse event course
Code List
Event Course
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
adverse event episodes
Item
Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
text
C1710066 (UMLS CUI [1])
adverse event intensity
Code List
Intensity (maximum)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
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)
Item
Relationship to Investigational Drug
text
C1518404 (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)
corrective therapy
Item
Corrective Therapy
boolean
C0877248 (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])
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