ID

26524

Beskrivning

Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy 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: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

Nyckelord

Versioner (1)
  1. 2017-10-18 2017-10-18 -
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18 oktober 2017

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7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

Engelsk

Serious Adverse Event

1 Formulär  
  1. StudyEvent: ODM
    1. Serious Adverse Event
Administrative Documentation
Beskrivning

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Serious Adverse Event (SAE)
Beskrivning

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE (Please print clearly)
Beskrivning

Reporting Person

Datatyp

text

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0700287
AEGIS Number
Beskrivning

Reporter Identifier

Datatyp

float

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0600091
Serious Adverse Event (Please print clearly)
Beskrivning

Serious Adverse Event

Datatyp

text

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

Reason Adverse Event

Datatyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1519255
GSK Use
Beskrivning

GSK Use

Datatyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457083
Onset Date and Time
Beskrivning

Date | Time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C2826806
UMLS CUI [1,2]
C1519255
End Date and Time (if ongoing please leave blank)
Beskrivning

End Date Time

Datatyp

datetime

Alias
UMLS CUI [1]
C2826793
Outcome *If subject died, please inform GSK within 24 hours and complete Form D
Beskrivning

Adverse Event Outcome

Datatyp

text

Alias
UMLS CUI [1]
C1705586
Event Course
Beskrivning

Course

Datatyp

text

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C1519255
Intensity (Maximum)
Beskrivning

Intensity

Datatyp

text

Alias
UMLS CUI [1,1]
C1710066
UMLS CUI [1,2]
C1519255
Action Taken with Respect to Investigational Drug
Beskrivning

Action Taken

Datatyp

text

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

Abation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3853704
assessment of adverse event
Beskrivning

Adverse event association C0877248

Datatyp

text

If yes, did SAE recur?
Beskrivning

Recurring Adverse Event

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1709874
UMLS CUI [1,2]
C1519255
Relationship to lnvestigational Drug
Beskrivning

Drug relationship

Datatyp

text

Alias
UMLS CUI [1]
C0277579
The SAE is probably associated with:
Beskrivning

Adverse event assessment

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3846158
Corrective Therapy If 'Yes' Please record on Concomitant Medication form
Beskrivning

Corrective therapy

Datatyp

boolean

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

Withdrawal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Remarks (Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary)
Beskrivning

SAE Remarks

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Relevant Laboratory Data Please provide relevant abnormal laboratory data below
Beskrivning

Relevant Laboratory Data Please provide relevant abnormal laboratory data below

Alias
UMLS CUI-1
C1705214
Test
Beskrivning

Test

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0332307
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Value
Beskrivning

Value

Datatyp

text

Alias
UMLS CUI [1]
C0587081
Units
Beskrivning

Unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Normal Range
Beskrivning

Normal Range

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0086715
Administrative Documentation
Beskrivning

Administrative Documentation

Alias
UMLS CUI-1
C1320722
If applicable, was randomisation code broken at investigational site?
Beskrivning

Randomisation Code

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C3899531
Randomisation/Study Medication Number:
Beskrivning

Randomisation Number | Study Medication Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Investigator's Signature: (confirming that the above data are accurate and complete)
Beskrivning

Investigator Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beskrivning

Investigator Signature Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Please PRINT Name
Beskrivning

Printed Name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
GSK Medical Monitor's Signature:
Beskrivning

Investigator Use

Datatyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457083
UMLS CUI [1,3]
C1519316
Investigator Use
Beskrivning

Investigator Use

Datatyp

date

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457083
UMLS CUI [1,3]
C2346576
UMLS CUI [1,4]
C0011008
Please PRINT Name
Beskrivning

Printed Name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Serious Adverse Event

1 Formulär
  1. StudyEvent: ODM
    1. Serious Adverse Event
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Serious Adverse Event (SAE)
C1519255 (UMLS CUI-1)
Reporting Person
Item
Person Reporting SAE (Please print clearly)
text
C0027361 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Reporter Identifier
Item
AEGIS Number
float
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event (Please print clearly)
text
C1519255 (UMLS CUI [1])
Item
Specify reason(s) for considering this a serious AE. Mark all that apply.
text
C0566251 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Reason Adverse Event
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 hospitalization (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
other (see definition) (F)
GSK Use
Item
GSK Use
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Date | Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End Date Time
Item
End Date and Time (if ongoing please leave blank)
datetime
C2826793 (UMLS CUI [1])
Item
Outcome *If subject died, please inform GSK within 24 hours and complete Form D
text
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Outcome *If subject died, please inform GSK within 24 hours and complete Form D
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
CL Item
Died* (Died*)
Item
Event Course
text
C0750729 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Course
Code List
Event Course
CL Item
Intermittent (Number of episodes) (1)
CL Item
Constant (2)
Item
Intensity (Maximum)
text
C1710066 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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
Dose interrupted/restarted (Dose interrupted/restarted)
CL Item
Drug stopped (Drug stopped)
Abation
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
assessment of adverse event
Item
text
Recurring Adverse Event
Item
If yes, did SAE recur?
boolean
C1709874 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Relationship to lnvestigational Drug
text
C0277579 (UMLS CUI [1])
Drug relationship
Code List
Relationship to lnvestigational 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
C0877248 (UMLS CUI [1,1])
C3846158 (UMLS CUI [1,2])
Adverse event assessment
Code List
The SAE is probably associated with:
CL Item
Protocol design or procedures (but not to study drug) Please specify (Protocol design or procedures (but not to study drug) Please specify)
CL Item
Another condition (eg, condition under study, intercurrent illness) Please specify (Another condition (eg, condition under study, intercurrent illness) Please specify)
CL Item
Another drug Please specify (Another drug Please specify)
Corrective therapy
Item
Corrective Therapy If 'Yes' Please record on Concomitant Medication form
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Withdrawal
Item
Was subject withdrawn due to this AE ?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE Remarks
Item
Remarks (Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary)
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Relevant Laboratory Data Please provide relevant abnormal laboratory data below
C1705214 (UMLS CUI-1)
Test
Item
Test
text
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Value
Item
Value
text
C0587081 (UMLS CUI [1])
Unit
Item
Units
text
C1519795 (UMLS CUI [1])
Normal Range
Item
Normal Range
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Item Group
C1320722 (UMLS CUI-1)
Randomisation Code
Item
If applicable, was randomisation code broken at investigational site?
boolean
C0034656 (UMLS CUI [1,1])
C3899531 (UMLS CUI [1,2])
Randomisation Number | Study Medication Number
Item
Randomisation/Study Medication Number:
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator's Signature: (confirming that the above data are accurate and complete)
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Printed Name
Item
Please PRINT Name
text
C2826892 (UMLS CUI [1])
Investigator Use
Item
GSK Medical Monitor's Signature:
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,3])
Investigator Use
Item
date
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Printed Name
Item
Please PRINT Name
text
C2826892 (UMLS CUI [1])
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