ID

26523

Description

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

Keywords

Versions (1)
  1. 10/18/17 10/18/17 -
Copyright Holder

GSK

Uploaded on

October 18, 2017

DOI

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License

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

English

Baseline Signs and Symptoms

1 forms  
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Please note any SERIOUS events should not be recorded on this page, but on the Serious Adverse Event pages provided. Record any Baseline events (using standard medical terminology) observed or elicited by the following direct question to subject: "How do you feel?" Provide the diagnosis, NOT symptoms where possible. (One baseline event per column)
Description

Please note any SERIOUS events should not be recorded on this page, but on the Serious Adverse Event pages provided. Record any Baseline events (using standard medical terminology) observed or elicited by the following direct question to subject: "How do you feel?" Provide the diagnosis, NOT symptoms where possible. (One baseline event per column)

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C1442488
Baseline Sign/Symptom
Description

Basline Signs and Symptoms

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
GSK Use
Description

Investigator Use

Data type

text

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

Onset Date and Time

Data type

datetime

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

End Date and Time

Data type

datetime

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

Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
Event Course
Description

Course

Data type

text

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

Intensity

Data type

text

Alias
UMLS CUI [1]
C1710066
Relationship to study procedures performed prior to randomisation
Description

Relation

Data type

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C2603343
UMLS CUI [1,4]
C0184661
Corrective Therapy If 'Yes', Please record on Prior Medication form.
Description

Corrective Therapy

Data type

boolean

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

Withdrawal

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1710677
UMLS CUI [1,3]
C1518404
Investigators Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Investigator Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Baseline Signs and Symptoms

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Please note any SERIOUS events should not be recorded on this page, but on the Serious Adverse Event pages provided. Record any Baseline events (using standard medical terminology) observed or elicited by the following direct question to subject: "How do you feel?" Provide the diagnosis, NOT symptoms where possible. (One baseline event per column)
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Basline Signs and Symptoms
Item
Baseline Sign/Symptom
text
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Investigator Use
Item
GSK Use
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time
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
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Course
Code List
Event Course
CL Item
Intermittent (No. of episodes) (Intermittent (No. 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
Relationship to study procedures performed prior to randomisation
text
C0085978 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
Relation
Code List
Relationship to study procedures performed prior to randomisation
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 Prior Medication form.
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Withdrawal
Item
Was subject withdrawn due to this event?
boolean
C2348568 (UMLS CUI [1,1])
C1710677 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Signature
Item
Investigators Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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