ID

26665

Beschrijving

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

Trefwoorden

Versies (1)
  1. 23-10-17 23-10-17 -
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GSK

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23 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

Engels

Adverse Event

1 Formulieren  
  1. StudyEvent: ODM
    1. Adverse Event
Please note any SERIOUS events should not be recorded on this page, but on the Serious Adverse Event pages provided. Record any Adverse event (using standard medical terminology) observed or elicited by the following direct question to the subject: "Do you feel different in any way since starting the treatment or since the last visit?" Provide the diagnosis not symptoms where possible. (One adverse event per column) If no adverse events, please mark box D and sign form below
Beschrijving

Please note any SERIOUS events should not be recorded on this page, but on the Serious Adverse Event pages provided. Record any Adverse event (using standard medical terminology) observed or elicited by the following direct question to the subject: "Do you feel different in any way since starting the treatment or since the last visit?" Provide the diagnosis not symptoms where possible. (One adverse event per column) If no adverse events, please mark box D and sign form below

Alias
UMLS CUI-1
C0877248
Adverse Event
Beschrijving

Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C0877248
GSK Use
Beschrijving

Investigator Use

Datatype

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457083
Onset Date/Time
Beschrijving

Onset Date/Time

Datatype

datetime

Alias
UMLS CUI [1]
C2826806
End Date/Time
Beschrijving

End Date/Time

Datatype

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Beschrijving

Outcome

Datatype

text

Alias
UMLS CUI [1]
C1705586
Event Course
Beschrijving

Event Course

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Intensity (Maximum)
Beschrijving

Intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Action Taken with Respect to lnvestigational Drug
Beschrijving

Drug Action Taken

Datatype

text

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0304229
Relationship to lnvestigational Drug
Beschrijving

Relationship to lnvestigational Drug

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Corrective Therapy. If "Yes", Please record on Concomitant Medication form
Beschrijving

Corrective Therapy

Datatype

boolean

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

Study withdrawal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0877248
Administrative Documentation
Beschrijving

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Investigator's Signature:
Beschrijving

Investigators Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date
Beschrijving

Investigator Signature Date

Datatype

date

Alias
UMLS CUI [1,1]
C0807937
UMLS CUI [1,2]
C2346576
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Similar models

Adverse Event

1 Formulieren
  1. StudyEvent: ODM
    1. Adverse Event
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Please note any SERIOUS events should not be recorded on this page, but on the Serious Adverse Event pages provided. Record any Adverse event (using standard medical terminology) observed or elicited by the following direct question to the subject: "Do you feel different in any way since starting the treatment or since the last visit?" Provide the diagnosis not symptoms where possible. (One adverse event per column) If no adverse events, please mark box D and sign form below
C0877248 (UMLS CUI-1)
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Investigator Use
Item
GSK Use
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Onset Date/Time
Item
Onset Date/Time
datetime
C2826806 (UMLS CUI [1])
End Date/Time
Item
End Date/Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
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])
Event Course
Code List
Event Course
CL Item
Intermittent (Number of Episodes) (Intermittent (Number of Episodes))
CL Item
Constant (Constant)
Item
Intensity (Maximum)
text
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity (Maximum)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Action Taken with Respect to lnvestigational Drug
text
C2826626 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Drug Action Taken
Code List
Action Taken with Respect to lnvestigational 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)
Item
Relationship to lnvestigational Drug
text
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Relationship to lnvestigational Drug
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)
Corrective Therapy
Item
Corrective Therapy. If "Yes", Please record on Concomitant Medication form
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Study withdrawal
Item
Was subject withdrawn due to this AE?
boolean
C0422727 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Investigators Signature
Item
Investigator's Signature:
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C0807937 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
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